Oral tablet formulations

Abstract

The present disclosure relates to pharmaceutical formulations comprising a HIV capsid inhibitor and methods for the prevention of a human immunodeficiency virus (HIV) infection in a patient.

Description

1592-US-NP / WO-PCT ORAL TABLET FORMULATIONSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U. S. Provisional Application No. 63 / 761,619, filed February 21, 2025, the entire contents of which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] The viral capsid protein (CA) is essential for multiple stages of the HIV life cycle. During viral maturation following the processing of Gag polyprotein by the HIV protease, CA self-assembles into the conical shaped core characteristic of mature HIV-1 virions. Contained within this capsid core are the viral RNA, nucleocapsid, reverse transcriptase, and integrase. Failure to generate a suitable core precludes infectivity. In addition, CA contributes to multiple essential processes during the early stages of HIV replication, including important roles in regulating proper capsid core disassembly (uncoating) kinetics to ensure efficient and productive viral DNA synthesis via coupled reverse transcription, and contributes to the active transport of pre-integration complexes into the nuclear compartment to support viral DNA integration into transcriptionally active loci. Defects in the proper function of capsid ultimately inhibit efficient nuclear uptake and integration of viral DNA into the host genome.

[0003] Human immunodeficiency virus type 1 infection is a life-threatening and serious disease of major public health significance, with approximately 38 million people infected worldwide and approximately 26 million on antiretroviral (ARV) treatment (UNAIDS. Global HIV & AIDS statistics, 2020 fact sheet). Advances in combination ARV therapy for HIV have led to significant improvements in morbidity and mortality by suppressing viral replication, preserving immunologic function, and averting disease progression to AIDS.1592-US-NP / WO-PCT SUMMARY

[0004] The present disclosure provides, inter alia, a tablet comprising a compound of Formula la:laor a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients.

[0005] The present disclosure further provides a method of preventing human immunodeficiency virus (HIV) infection in a patient, comprising administering to the patient a tablet provided herein.

[0006] The present disclosure further provides a tablet provided herein, for use in any of the methods described herein.

[0007] The present disclosure further provides use of a tablet provided herein, for use in any of the methods described herein.

[0008] The present disclosure further provides use of a tablet provided herein, for use in preparation of a medicament for use in any of the methods described herein.DESCRIPTION OF DRAWINGS

[0009] FIG. 1 shows a manufacturing process flow diagram for preparing the tablets described in Example 1.

[0010] FIGs. 2-5 show results of in vivo dog studies described in Example 2.

[0011] FIG. 6 shows plasma pharmacokinetic (PK) profiles of encequidar following intravenous (IV) and oral (PO) administration in non-clinical species (monkey, dog, and rat). Plasma concentration-time profiles are shown for IV administration at 1 mg / kg (blue circles) and PO administration at 10 mg / kg (red squares).1592-US-NP / WO-PCT

[0012] FIG. 7 shows pharmacokinetic (PK) profiles of orally administered digoxin (5 mg / kg) and paclitaxel (5 mg / kg) in Sprague-Dawley rats, paclitaxel (5 mg / kg) in beagle dogs, and talinolol (1 mg / kg) in cynomolgus monkeys with and without efflux inhibitors. Encequidar (5 mg / kg, red squares) and elacridar (10 mg / kg, green triangles) were co-administered orally to evaluate their effects on substrate plasma concentrations.

[0013] FIG. 8 shows pharmacokinetic (PK) profiles of single-dose intravenous (IV) administration of apixaban (0.33 mg / kg), talinolol (0.33 mg / kg), and lenacapavir (0.33 mg / kg) in beagle dogs, and paclitaxel (1 mg / kg) in Sprague-Dawley rats. Plasma concentration-time curves are shown with) and without co-administration of the P-gp inhibitors (5 mg / kg PO).

[0014] FIG. 9 shows improvement in bioavailability of lenacapavir in pentagastrin pretreated dogs upon administration of Compound 1, 350 mg fixed PO and solution vehicle.DETAILED DESCRIPTION

[0015] Pre-exposure prophylaxis (PrEP) strategies have been used to prevent transmission of HIV-1 infection. In locations where uptake of PrEP is high, there has been a significant population-level reduction in HIV incidence, demonstrating the potential for PrEP to contribute to population-wide HIV control (see e.g., Grulich et al, The Lancet. HIV, 2018; 5(ll):e629-e37; and Sullivan et al, Abstract LBPEC036, International AIDS Conference (IAC); July 2018, 23-27). However, for many individuals at risk for HIV, the uptake of daily oral PrEP has been a challenge. In the US, it is estimated that 1.1 million persons are at risk for HIV, yet only 240,000 are on Descovy or Truvada, and another 400,000 more started, but have stopped, daily oral PrEP. Several reasons likely contribute to the suboptimal uptake of PrEP, including lack of health system accessibility, medical mistrust due to experiences of homophobia, transphobia, and stigma, lack of willingness to take daily oral PrEP, concerns about side effects, and low selfperception of risk (see e.g., Center for Disease Control and Prevention, HIV / AIDS: Preexposure prophylaxis (PrEP); cdc.gov / hiv / basics / prep.html, 2017; and Wood et al, AIDS Behav.2019;23 (10):2719-29).

[0016] Lenacapavir (LEN), a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, has the potential to provide an additional option for populations at risk of HIV acquisition. Lenacapavir can help address substantial existing PrEP barriers including 1) requirement for daily adherence, 2) stigma and concerns about disclosure and discrimination or other social harms, 3) oral medication-associated adverse events (AEs), including gastrointestinal tolerability, and 4) challenges with access to health care providers in overburdened health systems or in geographical PrEP deserts. Thus, LEN has the potential to1592-US-NP / WO-PCT increase the uptake of, adherence to, and thereby the scalability of PrEP, thus contributing to the overarching goal of ending the HIV-1 epidemic.

[0017] The present invention relates to pharmaceutical compositions (e.g., tablets) comprising (2-(2-(4-(N-(4-chloro-7-(2-((S)-l-(2-((3bS,4aR)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-lH-cyclopropa[3,4]cyclopenta[l,2-c]pyrazol-l-yl)acetamido)-2-(3,5-difhiorophenyl)ethyl)-6-(3-methyl-3-(methylsulfonyl)but-l-yn-l-yl)pyridin-3-yl)-l-(2,2,2-trifhioroethyl)-lH-indazol-3-yl)methylsulfonamido)-2-methyl-4-oxobutan-2-yl)-5-methyl-3-(phosphonooxy)phenyl)acetyl)-L-aspartic acid (i.e., Compound 1, structure shown below; see e.g. U. S. Patent No.: 11,787,825, the disclosure of which is incorporated herein by reference in its entirety).Compound 1

[0018] Compound 1 converts to lenacapavir (i.e., N-((S)-l-(3-(4-chloro-3-(methylsulfonamido)-l-(2,2,2-trifhioroethyl)-lH-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-l-yn-l-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bS,4aR)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-lH-cyclopropa[3,4]cyclopenta[l,2-c]pyrazol-1-yl) acetamide), an HIV capsid inhibitor that is in development as a long-acting treatment for HIV, in the gastrointestinal tract when administered to a subject (e.g., a human patient).1592-US-NP / WO-PCTlenacapavir

[0019] Synthesis and characterization of lenacapavir, and salts thereof, are described, for example, in US 20180051005 and US 20190300505, the contents of each of which are hereby incorporated by reference in their entireties. Various forms and / or uses of the compounds of lenacapavir are disclosed, for example, in US 20190083478, US 20190084963, US 20200038389A1, and US 20210188815, the contents of each of which are hereby incorporated by reference in their entireties.

[0020] As used herein and in the appended claims, the singular forms "a" and "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, e.g., reference to "the compound" includes a plurality of such compounds, “a tablet” or “the tablet” includes reference to one or more tablets, and reference to "the assay" includes reference to one or more assays, and so forth.

[0021] The absolute stereochemistry is specified according to the Cahn-Ingold-Prelog R-S system. When a compound is a pure enantiomer the stereochemistry at each chiral carbon may be specified by either R or S. Resolved compounds whose absolute configuration is unknown can be designated (+) or (-) depending on the direction (dextro- or levorotatory) which they rotate plane polarized light at the wavelength of the sodium D line. Certain of the compounds and salts described herein contain one or more asymmetric centers and / or hindered rotation about a bond axis and may thus give rise to enantiomers, diastereomers, and other stereoisomeric forms that may be defined, in terms of absolute stereochemistry, as (R)- or (S)-. The present disclosure is meant to include all such possible isomers, including racemic mixtures, scalemic mixtures, diastereomeric mixtures, optically pure forms and intermediate mixtures. Optically active (R)- and (S)- isomers may be prepared using chiral synthons or chiral reagents, or resolved using conventional techniques.

[0022] Except as expressly defined otherwise, the present disclosure includes all tautomers of compounds detailed herein, even if only one tautomer is expressly represented (e.g., both1592-US-NP / WO-PCT tautomeric forms are intended and described by the presentation of one tautomeric form where a pair of two tautomers may exist). For example, if reference is made to a compound containing an amide (e.g., by structure or chemical name), it is understood that the corresponding imidic acid tautomer is included by this disclosure and described the same as if the amide were expressly recited either alone or together with the imidic acid. Where more than two tautomers may exist, the present disclosure includes all such tautomers even if only a single tautomeric form is depicted by chemical name and / or structure.

[0023] Compounds described herein may have chiral centers and / or geometric isomeric centers (E- and Z- isomers), and it is to be understood that all such optical, enantiomeric, diastereoisomeric and geometric isomers are encompassed. Where compounds are represented in their chiral form, it is understood that the embodiment encompasses, but is not limited to, the specific diastereomerically or enantiomeric ally enriched form. Where chirality is not specified but is present, it is understood that the embodiment is directed to either the specific diastereomerically or enantiomerically enriched form; or a racemic or scalemic mixture of such compound(s).

[0024] One skilled in the art understands that a compound structure may be named or identified using commonly recognized nomenclature systems and symbols. By way of example, the compound may be named or identified with common names, systematic or non- systematic names. The nomenclature systems and symbols that are commonly recognized in the art of chemistry including but not limited to Chemical Abstract Service (CAS) and International Union of Pure and Applied Chemistry (IUPAC). Accordingly, the compound structure for Compound 1 provided above may also be named or identified as (2-(2-(4-(N-(4-chloro-7-(2-((S)-l-(2-((3bS,4aR)-5,5-difhioro-3-(trifhioromethyl)-3b,4,4a,5-tetrahydro-lH-cyclopropa[3,4]cyclopenta[l,2-c]pyrazol-l-yl)acetamido)-2-(3,5-difluorophenyl)ethyl)-6-(3-methyl-3-(methylsulfonyl)but-l-yn-l-yl)pyridin-3-yl)-l-(2,2,2-trifluoroethyl)-lH-indazol-3-yl)methylsulfonamido)-2-methyl-4-oxobutan-2-yl)-5-methyl-3-(phosphonooxy)phenyl)acetyl)-L-aspartic acid.

[0025] Reference to “about” a value or parameter herein includes (and describes) embodiments that are directed to that value or parameter per se. In certain embodiments, the term “about” includes the indicated amount ± 10%. In other embodiments, the term “about” includes the indicated amount ± 5%. In certain other embodiments, the term “about” includes the indicated amount ± 1%. Also, the term “about X” includes description of “X”.

[0026] As used herein, the term “consists essentially of’ means that, in addition to the mandatory ingredients, specific further ingredients can be present, namely those not materially1592-US-NP / WO-PCT affecting the essential characteristics of the composition or component in question.Compositions or components herein which “consist essentially of’ the specified ingredients may consist only of the specified ingredients, with no other ingredients present.

[0027] Kolliphor® HS-15 (CAS No. 70142-34-6) is a non-ionic solubilizer and emulsifying agent obtained by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxy stearic acid. Kolliphor® HS-15 consists of polyglycol mono- and di-esters of 12-hydroxy stearic acid (= lipophilic part) and of about 30% of free polyethylene glycol (= hydrophilic part). Kolliphor® HS-15 is also known as Macrogol 15 Hydroxystearate (Ph. Eur.), or Polyoxyl 15 Hydrostearate (USP / NF).

[0028] Kolliphor® RH 40 is a non-ionic solubilizer and emulsifying agent obtained by reacting 1 mole of hydrogenated castor oil with 40 moles of ethylene oxide. The main constituent of Kolliphor® RH 40 is glycerol polyethylene glycol hydroxy- stearate, which, together with fatty acid glycerol polyglycol esters, forms the hydrophobic part of the product. The hydrophilic part consists of polyethylene glycols and glycerol ethoxylate. Kolliphor® RH 40 is also known as Macroglycerol Hydroxystearate (Ph. Eur.) or Polyoxyl 40 Hydrogenated Castor Oil (USP / NF).Pharmaceutical Compositions

[0029] Accordingly, the present disclosure provides pharmaceutical compositions comprising a compound of Formula la or lb:1592-US-NP / WO-PCTIbor a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier.

[0030] Pharmaceutical compositions of the disclosure are formulated so as to allow the active ingredients contained therein to be bioavailable upon administration of the composition to a patient. Compositions that will be administered to a patient take the form of one or more dosage units (e.g., one or more tablets). Actual methods of preparing such dosage forms are known, or will be apparent, to those skilled in this art; for example, see Remington: The Science and Practice of Pharmacy, 20th Edition (Philadelphia College of Pharmacy and Science, 2000). The composition to be administered will, in any event, contain a prophylactically effective amount of the compound of Formula la or Ib, or a pharmaceutically acceptable salt thereof, for prevention of an HIV infection, or reducing the risk of acquiring an HIV infection, as described herein.

[0031] The term “prophylactically effective amount” or “effective amount” of a compound described herein means an amount sufficient to effect prevention of an HIV infection, or reduce the risk of acquiring an HIV infection, when administered to a subject. The prophylactically effective amount may vary, for example, depending on the subject, the weight and age of the subject, and the manner of administering, which can readily be determined by one of ordinary skill in the art.

[0032] As used herein, “pharmaceutically acceptable carrier” is meant to refer to any adjuvant, carrier, excipient, filler, disintegrant, glidant, sweetening agent, diluent, preservative, dye / colorant, flavor enhancer, surfactant, wetting agent, dispersing agent, suspending agent, stabilizer, isotonic agent, solvent, or emulsifier which has been approved by the United States Food and Drug Administration as being acceptable for use in humans or domestic animals.1592-US-NP / WO-PCT

[0033] In some embodiments, the compound of Formula la or lb is administered as a salt, such as a pharmaceutically acceptable salt. A salt generally refers to a derivative of a disclosed compound wherein the parent compound is modified by converting an existing acid or base moiety to its salt form. A pharmaceutically acceptable salt is one that, within the scope of sound medical judgment, is suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines, alkali or organic salts of acidic residues such as carboxylic acids, and the like. The pharmaceutically acceptable salts of the present disclosure include the conventional non-toxic salts of the parent compound formed, for example, from non-toxic inorganic or organic acids. The pharmaceutically acceptable salts of the present disclosure can be synthesized from the parent compound which contains a basic or acidic moiety by conventional chemical methods. Generally, such salts can be prepared by reacting the free acid or base forms of these compounds with a stoichiometric amount of the appropriate base or acid. Lists of suitable salts are found in Remington’s Pharmaceutical Sciences, 17thed., Mack Publishing Company, Easton, Pa., 1985, p. 1418 and Journal of Pharmaceutical Science, 66, 2 (1977), each of which is incorporated herein by reference in its entirety.

[0034] In some embodiments, the pharmaceutical composition provided herein is a tablet. In some embodiments, the tablet provided herein comprises a compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients. In some embodiments, the tablet provided herein comprises a compound of Formula la, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients. In some embodiments, the tablet provided herein comprises a compound of Formula lb, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients.

[0035] In some embodiments, the active ingredient is a compound of Formula la, or a pharmaceutically acceptable salt thereof. In some embodiments, the active ingredient is a compound of Formula lb, or a pharmaceutically acceptable salt thereof.

[0036] In some embodiments, the active ingredient is a compound of Formula la (z.e., a free acid form of the compound of Formula la). In some embodiments, the active ingredient is a compound of Formula lb (z.e., a free acid form of the compound of Formula lb).1592-US-NP / WO-PCT

[0037] In some embodiments, the active ingredient is an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the active ingredient is an amorphous form of the free acid form of the compound of Formula lb.

[0038] In some embodiments, the tablet disclosed herein comprises a compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients selected from the group consisting of a filler, a disintegrant, and a lubricant.

[0039] In some embodiments, the tablet disclosed herein comprises a compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, a filler, a disintegrant, and a lubricant.

[0040] In some embodiments, the tablet disclosed herein comprises a compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, about 20 w / w% to about 55 w / w% of one or more fillers, about 1 w / w% to 15 w / w% of one or more disintegrants, and about 1 w / w% to 5 w / w% of one or more lubricants.

[0041] In some embodiments, the tablet disclosed herein comprises a compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, about 20 w / w% to about 55 w / w% of the one or more fillers, about 4 w / w% to about 15 w / w% of the one or more disintegrants, and about 1 w / w% to about 5 w / w% of the one or more lubricant.

[0042] In some embodiments, the one or more fillers are each independently selected from microcrystalline cellulose, mannitol, lactose monohydrate, and silicified microcrystalline cellulose. In some embodiments, the one or more fillers are each independently selected from microcrystalline cellulose, mannitol, and silicified microcrystalline cellulose. In some embodiments, the one or more fillers are each independently selected from microcrystalline cellulose and mannitol. In some embodiments, the disintegrant is crospovidone. In some embodiments, the lubricant is magnesium stearate.

[0043] In some embodiments, the tablet provided herein comprises about 30 w / w% to about 80 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, for example, about 30 w / w%, about 35 w / w%, about 40 w / w%, about 45 w / w%, about 50 w / w%, about 55 w / w%, about 60 w / w%, about 65 w / w%, about 70 w / w%, about 75 w / w%, or about 80 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0044] In some embodiments, the tablet provided herein comprises about 30 w / w% to about 80 w / w% of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 30 w / w% to about 80 w / w% of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 30 w / w% to about 80 w / w% of a free acid form of the compound of Formula lb. In some1592-US-NP / WO-PCT embodiments, the tablet provided herein comprises about 30 w / w% to about 80 w’ / w’^c of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 30to about 80 of an amorphous form of the compound of Formula lb.

[0045] In some embodiments, the tablet provided herein comprises about 35to about 75 of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 35to about 75of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 35to about 75 of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 35to about 75of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 35to about 75of an amorphous form of the compound of Formula lb.

[0046] In some embodiments, the tablet provided herein comprises about 40to about 70 of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 40to about 70of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 40to about 70 of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 40to about 70of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 40to about 70of an amorphous form of the compound of Formula lb.

[0047] In some embodiments, the tablet provided herein comprises about 50to about 70 of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 50to about 70of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 50to about 70 of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 50to about 70of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 50to about 70of an amorphous form of the compound of Formula lb.

[0048] In some embodiments, the tablet provided herein comprises about 55to about 65 of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 55 to about 65of a free acid form of the1592-US-NP / WO-PCT compound of Formula la. In some embodiments, the tablet provided herein comprises about 55 w / w% to about 65 w / w% of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 55 w / w% to about 65 w / w% of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 55 w / w% to about 65 w / w% of an amorphous form of the compound of Formula lb.

[0049] In some embodiments, the tablet provided herein comprises about 58 w / w% to about 62 w / w% of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 58 w / w% to about 62 w / w% of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 58 w / w% to about 62 w / w% of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 58 w / w% to about 62 w / w% of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 58 w / w% to about 62of an amorphous form of the compound of Formula lb.

[0050] In some embodiments, the tablet provided herein comprises about 59to about 61 of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 59to about 61of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 59to about 61 of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 59to about 61of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 59to about 61of an amorphous form of the compound of Formula lb.

[0051] In some embodiments, the tablet provided herein comprises about 60of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 60of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 60of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 60 of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 60of an amorphous form of the compound of Formula lb.

[0052] In some embodiments, the tablet provided herein comprises about 40of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided1592-US-NP / WO-PCT herein comprises about 40 w / w% of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 40of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 40 of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 40of an amorphous form of the compound of Formula lb.

[0053] In some embodiments, the tablet provided herein comprises about 70of a free acid form of the compound of Formula la or lb. In some embodiments, the tablet provided herein comprises about 70of a free acid form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 70of a free acid form of the compound of Formula lb. In some embodiments, the tablet provided herein comprises about 70 of an amorphous form of the compound of Formula la. In some embodiments, the tablet provided herein comprises about 70of an amorphous form of the compound of Formula lb.

[0054] In some embodiments, the tablet comprises the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula la or lb, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula la, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula lb, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula la, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula lb, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate, or any combination thereof.1592-US-NP / WO-PCT

[0055] In some embodiments, the tablet comprises the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula la or lb, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula la, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula lb, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula la, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula lb, and one or more pharmaceutically acceptable excipients selected from mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof.

[0056] In some embodiments, the tablet comprises the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients selected from microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula la or lb, and one or more pharmaceutically acceptable excipients selected from microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula la, and one or more pharmaceutically acceptable excipients selected from microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises the free acid form of the compound of Formula lb, and one or more pharmaceutically acceptable excipients selected from microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula la, and one or more pharmaceutically acceptable excipients selected from microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof.1592-US-NP / WO-PCT In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula lb, and one or more pharmaceutically acceptable excipients selected from microcrystalline cellulose, crospovidone, and magnesium stearate, or any combination thereof.

[0057] In some embodiments, the tablet comprises the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula la or lb, mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula la, mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula lb, mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula la, mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula lb, mannitol, microcrystalline cellulose, crospovidone, poloxamer 407, and magnesium stearate.

[0058] In some embodiments, the tablet comprises the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula la or lb, mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula la, mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula lb, mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula la, mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula lb, mannitol, microcrystalline cellulose, crospovidone, and magnesium stearate.

[0059] In some embodiments, the tablet comprises the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula la or lb, microcrystalline cellulose, crospovidone, and magnesium1592-US-NP / WO-PCT stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula la, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises the free acid form of the compound of Formula lb, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula la, microcrystalline cellulose, crospovidone, and magnesium stearate. In some embodiments, the tablet comprises an amorphous form of the free acid form of the compound of Formula lb, microcrystalline cellulose, crospovidone, and magnesium stearate.

[0060] In some embodiments, the tablet comprises about 10 w / w% to about 30 w / w% of mannitol, for example, about 10 NlN%, about 11 NlN%, about 12 w / w%, about 13 NlN%, about14 about 15 about 16 about 17 about 18 about19 about 20 about 21about 22about 23about 24about 25about 26 about 27 about 28 about 29 about 30 wlwlc mannitol.

[0061] In some embodiments, the tablet comprises about 12to about 30of mannitol. In some embodiments, the tablet comprises about10 to about 20of mannitol. In some embodiments, the tablet comprises about10 to about17 of mannitol. In some embodiments, the tablet comprises about12 to about17 of mannitol. In some embodiments, the tablet comprises about 11mannitol. In some embodiments, the tablet comprises about 11.75mannitol. In some embodiments, the tablet comprises about 12 w / w% mannitol. In some embodiments, the tablet comprises about 12.75 mannitol. In some embodiments, the tablet comprises about14 mannitol. In some embodiments, the tablet comprises about 14.25mannitol. In some embodiments, the tablet comprises about16 mannitol. In some embodiments, the tablet comprises about 16.75 mannitol. In some embodiments, the tablet comprises about 20to about 30 of mannitol. In some embodiments, the tablet comprises about 25to about 30 of mannitol. In some embodiments, the tablet comprises about 25to about 28 of mannitol. In some embodiments, the tablet comprises about 26of mannitol. In some embodiments, the tablet comprises about 26.75of mannitol. In some embodiments, the tablet comprises about 27of mannitol.

[0062] In some embodiments, the tablet comprises about 0.1 w / w% to about 5 w / w% poloxamer 407, for example, about 0.1 NlN%, about 0.5 NlN%, about 1 NlN%, about 2 w / w%, about 3 Nl^N%, about 4 w / w%, or about 5 poloxamer 407. In some embodiments, the tablet comprises about 1to about 5 poloxamer 407. In some embodiments, the1592-US-NP / WO-PCT tablet comprises about 2 w / w% to about 4 w / w% poloxamer 407. In some embodiments, the tablet comprises about 3poloxamer 407.

[0063] In some embodiments, the tablet comprises about 10 w / w% to about 35 w / w% of microcrystalline cellulose, for example, about 10 NlN%, about 11 \^\\C / L about 12 \^\\C / L about13 about 14 about 15 about 16 about 17 about18 about 19 about 20about 21about 22about 23about 24about 25 about 26 about 27 about 28 about 29about 30 about 31about 32about 33about 34or about 35 microcrystalline cellulose.

[0064] In some embodiments, the tablet comprises about 10to about 20of microcrystalline cellulose. In some embodiments, the tablet comprises about10 to about 17 of microcrystalline cellulose. In some embodiments, the tablet comprises about 11 of microcrystalline cellulose. In some embodiments, the tablet comprises about 11.75 of microcrystalline cellulose. In some embodiments, the tablet comprises about 12of microcrystalline cellulose. In some embodiments, the tablet comprises about 12.75of microcrystalline cellulose. In some embodiments, the tablet comprises about 14 'w w% of microcrystalline cellulose. In some embodiments, the tablet comprises about 14.25of microcrystalline cellulose. In some embodiments, the tablet comprises about16 of microcrystalline cellulose. In some embodiments, the tablet comprises about 16.25of microcrystalline cellulose.

[0065] In some embodiments, the tablet comprises about 20to about 35of microcrystalline cellulose. In some embodiments, the tablet comprises about 25to about 35 of microcrystalline cellulose. In some embodiments, the tablet comprises about 25to about 30 of microcrystalline cellulose. In some embodiments, the tablet comprises about 26to about 29of microcrystalline cellulose. In some embodiments, the tablet comprises about 27to about 29of microcrystalline cellulose. In some embodiments, the tablet comprises about 26.75of microcrystalline cellulose. In some embodiments, the tablet comprises about 27of microcrystalline cellulose. In some embodiments, the tablet comprises about 27.5of microcrystalline cellulose. In some embodiments, the tablet comprises about 28of microcrystalline cellulose. In some embodiments, the tablet comprises about 28.5of microcrystalline cellulose.

[0066] In some embodiments, the tablet comprises about 1 w / w% to about 15 w / w% of crospovidone, for example, about 1 NlN%, about 2 w / w%, about 3 NlN%, about 4 w / w%, about1592-US-NP / WO-PCT 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, about 10 w / w%, about 11 Nl^N%, about 12 w / w%, about 13 NlN%, about 14 w / w%, or about 15 w' / w’^c crospovidone.

[0067] In some embodiments, the tablet comprises about 5 w / w% to about 15 w / w% of crospovidone. In some embodiments, the tablet comprises about 3to about 11of crospovidone. In some embodiments, the tablet comprises about 4 'w w% to about10 of crospovidone. In some embodiments, the tablet comprises about 8to about 12 'w w% of crospovidone. In some embodiments, the tablet comprises about 9to about 11of crospovidone. In some embodiments, the tablet comprises about 4of crospovidone. In some embodiments, the tablet comprises about 5of crospovidone. In some embodiments, the tablet comprises about10 of crospovidone.

[0068] In some embodiments, the tablet comprises about 1 w / w% to about 5 w / w% of magnesium stearate, for example, about 1about 2 w / w%, about 3about 4 w / w%, or about 5 magnesium stearate. In some embodiments, the tablet comprises about 1to about 3 of magnesium stearate. In some embodiments, the tablet comprises about 1 w / w% to about 2.5 w / w% of magnesium stearate. In some embodiments, the tablet comprises about 1.5to about 2of magnesium stearate. In some embodiments, the tablet comprises about 1.5of magnesium stearate. In some embodiments, the tablet comprises about 2of magnesium stearate.

[0069] In some embodiments, the tablet comprises or consists essentially of:about 30 w / w% to about 80 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0070] In some embodiments, the tablet comprises or consists essentially of:about 30to about 80 w / w% of the free acid form of the compound of Formula la or lb;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.1592-US-NP / WO-PCT

[0071] In some embodiments, the tablet comprises or consists essentially of:about 35 w / w% to about 45 w / w% of the free acid form of the compound of Formula la or lb;about 25 w / w% to about 30 w / w% of mannitol;about 25 w / w% to about 30 w / w% of microcrystalline cellulose;about 3 w / w% to about 6 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% magnesium stearate.

[0072] In some embodiments, the tablet comprises or consists essentially of:about 40 w / w% of the free acid form of the compound of Formula la or lb;about 27 w / w% of mannitol;about 27.5 w / w% of microcrystalline cellulose;about 4 of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0073] In some embodiments, the tablet comprises or consists essentially of:about 40of the free acid form of the compound of Formula la or lb;about 26.75of mannitol;about 26.75of microcrystalline cellulose;about 5 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0074] In some embodiments, the tablet comprises or consists essentially of:about 50 w / w% to about 80 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 10 to about20 of mannitol;about 10to about 20 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0075] In some embodiments, the tablet comprises or consists essentially of:about 55to about 75of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 10 to about20 of mannitol;about 10to about 20 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.1592-US-NP / WO-PCT

[0076] In some embodiments, the tablet comprises or consists essentially of:about 55 w / w% to about 75 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 10 w / w% to about 20 w / w% of mannitol;about 10 w / w% to about 20 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone;about 2to about 4 w / w% poloxamer 407; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0077] In some embodiments, the tablet comprises or consists essentially of:about 50to about 80 w / w% of the free acid form of the compound of Formula la or lb;about 10 to about20 of mannitol;about 10to about 20 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0078] In some embodiments, the tablet comprises or consists essentially of:about 55to about 75 w / w% of the free acid form of the compound of Formula la or lb;about 10 to about20 of mannitol;about 10to about 20 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0079] In some embodiments, the tablet comprises or consists essentially of:about 55to about 75 w / w% of the free acid form of the compound of Formula la or lb;about 10 to about20 of mannitol;about 10to about 20 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone;about 2to about 4 w / w% poloxamer 407; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0080] In some embodiments, the tablet comprises or consists essentially of:about 60of the free acid form of the compound of Formula la or lb;about 16.75of mannitol;about 16.75of microcrystalline cellulose;1592-US-NP / WO-PCT about 5 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0081] In some embodiments, the tablet comprises or consists essentially of:about 70 w / w% of the free acid form of the compound of Formula la or lb;about 11.75 w / w% of mannitol;about 11.75 w / w% of microcrystalline cellulose;about 5 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0082] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the free acid form of the compound of Formula la or lb;about 14.25 w / w% of mannitol;about 14.25 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0083] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the free acid form of the compound of Formula la or lb;about 12.75 w / w% of mannitol;about 12.75 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone;about 3 w / w% poloxamer 407; andabout 1.5 w / w% of magnesium stearate.

[0084] In some embodiments, the tablet comprises or consists essentially of:about 50 w / w% to about 70 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 25 w / w% to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0085] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0086] In some embodiments, the tablet comprises or consists essentially of:about 55 w / w% to about 65 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 25 w / w% to about 30 w / w% of microcrystalline cellulose;1592-US-NP / WO-PCT about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0087] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0088] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0089] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0090] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises or consists essentially of:about 50to about 70of the free acid form of the compound of Formula la or lb;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0091] In some embodiments, the tablet comprises or consists essentially of:about 55to about 65 w / w% of the free acid form of the compound of Formula la or lb;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0092] In some embodiments, the tablet comprises or consists essentially of:about 60of the free acid form of the compound of Formula la or lb;about 28.5of microcrystalline cellulose;1592-US-NP / WO-PCT about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0093] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the free acid form of the compound of Formula la or lb;about 28 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0094] In some embodiments, the tablet comprises or consists essentially of:about 50to about 70of an amorphous form of the free acid form of the compound of Formula la or lb;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0095] In some embodiments, the tablet comprises or consists essentially of:about 55to about 65of an amorphous form of the free acid form of the compound of Formula la or lb;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0096] In some embodiments, the tablet comprises or consists essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la or lb;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0097] In some embodiments, the tablet comprises or consists essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la or lb;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0098] In some embodiments, the tablet comprises or consists essentially of:1592-US-NP / WO-PCT about 50 w / w% to about 70 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0099] In some embodiments, the tablet comprises or consists essentially of:about 55to about 65of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0100] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0101] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0102] In some embodiments, the tablet comprises or consists essentially of:about 50to about 70 w / w% of the free acid form of the compound of Formula la; about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0103] In some embodiments, the tablet comprises or consists essentially of:about 55 w / w% to about 65 w / w% of the free acid form of the compound of Formula la; about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0104] In some embodiments, the tablet comprises or consists essentially of:1592-US-NP / WO-PCT about 60 w / w% of the free acid form of the compound of Formula la;about 28.5 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0105] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the free acid form of the compound of Formula la;about 28 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0106] In some embodiments, the tablet comprises or consists essentially of:about 50to about 70of an amorphous form of the free acid form of the compound of Formula la;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0107] In some embodiments, the tablet comprises or consists essentially of:about 55to about 65of an amorphous form of the free acid form of the compound of Formula la;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0108] In some embodiments, the tablet comprises or consists essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0109] In some embodiments, the tablet comprises or consists essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0110] In some embodiments, the tablet comprises or consists essentially of:1592-US-NP / WO-PCT about 50 w / w% to about 70 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0111] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the compound of Formula lb, or a pharmaceutically acceptable salt thereof.

[0112] In some embodiments, the tablet comprises or consists essentially of:about 55to about 65of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0113] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the compound of Formula lb, or a pharmaceutically acceptable salt thereof.

[0114] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0115] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0116] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the compound of Formula lb, or a pharmaceutically acceptable salt thereof.

[0117] In some embodiments, the tablet comprises or consists essentially of:about 50to about 70 of the free acid form of the compound of Formula lb;1592-US-NP / WO-PCT about 25 w’ / w’^c to about 35 w’ / w’^c of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0118] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the free acid form of the compound of Formula lb.

[0119] In some embodiments, the tablet comprises or consists essentially of:about 55 w / w% to about 65 w / w% of the free acid form of the compound of Formula lb; about 25 w / w% to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0120] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the free acid form of the compound of Formula lb.

[0121] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the free acid form of the compound of Formula lb;about 28.5 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0122] In some embodiments, the tablet comprises or consists essentially of:about 60 w / w% of the free acid form of the compound of Formula lb;about 28 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0123] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the free acid form of the compound of Formula lb.

[0124] In some embodiments, the tablet comprises or consists essentially of:about 50to about 70of an amorphous form of the free acid form of the compound of Formula lb;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0125] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the amorphous form of the free acid form of the compound of Formula lb.

[0126] In some embodiments, the tablet comprises or consists essentially of:1592-US-NP / WO-PCT about 55 w / w% to about 65 w / w% of an amorphous form of the free acid form of the compound of Formula lb;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0127] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the amorphous form of the free acid form of the compound of Formula lb.

[0128] In some embodiments, the tablet comprises or consists essentially of:about 60of an amorphous form of the free acid form of the compound of Formula lb;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0129] In some embodiments, the tablet comprises or consists essentially of:about 60of an amorphous form of the free acid form of the compound of Formula lb;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0130] In some embodiments, the tablet may comprise or consist essentially of about 300 mg or about 700 mg of the amorphous form of the free acid form of the compound of Formula lb.

[0131] In some embodiments, the tablet comprises about 1 mg to about 2000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, for example, about 1 mg, about 5 mg, about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1125 mg, about 1150 mg, about 1175 mg, about 1200 mg, about 1225 mg, about 1250 mg, about 1275 mg, about 1300 mg, about 1325 mg, about 1350 mg,1592-US-NP / WO-PCT about 1375 mg, about 1400 mg, about 1425 mg, about 1450 mg, about 1475 mg, about 1500 mg, about 1525 mg, about 1550 mg, about 1575 mg, about 1600 mg, about 1625 mg, about 1650 mg, about 1675 mg, about 1700 mg, about 1725 mg, about 1750 mg, about 1775 mg, about 1800 mg, about 1825 mg, about 1850 mg, about 1875 mg, about 1900 mg, about 1925 mg, about 1950 mg, about 1975 mg, or about 2000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0132] In some embodiments, the tablet comprises about 225 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 250 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 275 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 300 mg to about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0133] In some embodiments, the tablet comprises about 300 mg to about 310 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 305 mg to about 307 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 306 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 306 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 306 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 306 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 306 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 306 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 300 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 300 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 300 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 300 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 300 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 300 mg of an amorphous form of the free acid form of the compound of Formula lb.1592-US-NP / WO-PCT

[0134] In some embodiments, the tablet comprises about 100 mg to about 500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 200 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 250 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 300 mg to about 400 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 325 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 340 mg to about 360 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 345 mg to about 355 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 349 mg to about 351 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0135] In some embodiments, the tablet comprises about 100 mg to about 500 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 200 mg to about 450 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 250 mg to about 450 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 300 mg to about 400 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 325 mg to about 375 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 340 mg to about 360 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 345 mg to about 355 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 349 mg to about 351 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 350 mg of the compound of the free acid form of the compound of Formula la or lb.1592-US-NP / WO-PCT

[0136] In some embodiments, the tablet comprises about 100 mg to about 500 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 200 mg to about 450 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 250 mg to about 450 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 300 mg to about 400 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 325 mg to about 375 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 340 mg to about 360 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 345 mg to about 355 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 349 mg to about 351 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 350 mg of the compound of the free acid form of the compound of Formula la.

[0137] In some embodiments, the tablet comprises about 100 mg to about 500 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 200 mg to about 450 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 250 mg to about 450 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 300 mg to about 400 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 325 mg to about 375 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 340 mg to about 360 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 345 mg to about 355 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 349 mg to about 351 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 350 mg of the compound of the free acid form of the compound of Formula lb.

[0138] In some embodiments, the tablet comprises about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises1592-US-NP / WO-PCT about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la or lb.

[0139] In some embodiments, the tablet comprises about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la.

[0140] In some embodiments, the tablet comprises about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 200 mg to about 450 mg of an amorphous form of the free acid form of the1592-US-NP / WO-PCT compound of Formula lb. In some embodiments, the tablet comprises about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula lb.

[0141] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 600 mg to about 800 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 600 mg to about 750 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 650 mg to about 750 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 675 mg to about 725 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 690 mg to about 710 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 695 mg to about 705 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 699 mg to about 701 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 700 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0142] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 600 mg to about 800 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 600 mg to about 750 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 650 mg to about 750 mg of the free acid form of the compound of Formula la or lb. In some embodiments,1592-US-NP / WO-PCT the tablet comprises about 675 mg to about 725 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 690 mg to about 710 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 695 mg to about 705 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 699 mg to about 701 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 700 mg of the free acid form of the compound of Formula la or lb.

[0143] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 600 mg to about 800 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 600 mg to about 750 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 650 mg to about 750 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 675 mg to about 725 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 690 mg to about 710 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 695 mg to about 705 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 699 mg to about 701 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 700 mg of the free acid form of the compound of Formula la.

[0144] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 600 mg to about 800 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 600 mg to about 750 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 650 mg to about 750 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 675 mg to about 725 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 690 mg to about 710 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 695 mg to about 705 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 699 mg to about 701 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 700 mg of the free acid form of the compound of Formula lb.1592-US-NP / WO-PCT

[0145] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 600 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 650 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 695 mg to about 705 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 699 mg to about 701 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 700 mg of an amorphous form of the free acid form of the compound of Formula la or lb.

[0146] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 600 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 650 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 695 mg to about 705 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 699 mg to about 701 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 700 mg of an amorphous form of the free acid form of the compound of Formula la.

[0147] In some embodiments, the tablet comprises about 500 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 600 mg to1592-US-NP / WO-PCT about 750 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 650 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 695 mg to about 705 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 699 mg to about 701 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 700 mg of an amorphous form of the free acid form of the compound of Formula lb.

[0148] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 875 mg to about 925 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 890 mg to about 910 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 895 mg to about 905 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 899 mg to about 901 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 900 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0149] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 875 mg to about 925 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 890 mg to about 910 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some1592-US-NP / WO-PCT embodiments, the tablet comprises about 895 mg to about 905 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 899 mg to about 901 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 900 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof.

[0150] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 875 mg to about 925 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 890 mg to about 910 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 895 mg to about 905 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 899 mg to about 901 mg of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 900 mg of the free acid form of the compound of Formula la or lb.

[0151] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 875 mg to about 925 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 890 mg to about 910 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 895 mg to about 905 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 899 mg to about 901 mg of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 900 mg of the free acid form of the compound of Formula la.

[0152] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 875 mg to about 925 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet1592-US-NP / WO-PCT comprises about 890 mg to about 910 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 895 mg to about 905 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 899 mg to about 901 mg of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 900 mg of the free acid form of the compound of Formula lb.

[0153] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 875 mg to about 925 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 890 mg to about 910 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 895 mg to about 905 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 899 mg to about 901 mg of an amorphous form of the free acid form of the compound of Formula la or lb. In some embodiments, the tablet comprises about 900 mg of an amorphous form of the free acid form of the compound of Formula la or lb.

[0154] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 650 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 875 mg to about 925 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 890 mg to about 910 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 895 mg to about 905 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 899 mg to about 901 mg of an amorphous form of the free acid form of the compound of Formula la. In some embodiments, the tablet comprises about 900 mg of an amorphous form of the free acid form of the compound of Formula la.

[0155] In some embodiments, the tablet comprises about 800 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments,1592-US-NP / WO-PCT the tablet comprises about 650 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 800 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 875 mg to about 925 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 890 mg to about 910 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 895 mg to about 905 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 899 mg to about 901 mg of an amorphous form of the free acid form of the compound of Formula lb. In some embodiments, the tablet comprises about 900 mg of an amorphous form of the free acid form of the compound of Formula lb.

[0156] The tablets disclosed herein may be uncoated or coated (in which case they include an outer film coat). Although uncoated tablets may be used, it is more usual to provide a coated tablet, in which case a conventional non-enteric coating may be used. Film coatings are known in the art and can be composed of hydrophilic polymer materials, but are not limited to, polysaccharide materials, such as hydroxypropylmethyl cellulose (HPMC), methylcellulose, hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), poly(vinylalcohol-co-ethylene glycol) and other water soluble polymers. Though the water-soluble material included in the film coating of the tablets may include a single polymer material, it may also be formed using a mixture of more than one polymer. The coating may be white or colored. Suitable coatings include, but are not limited to, polymeric film coatings such as those comprising polyvinyl alcohol e.g. ‘Opadry® II’ (which includes part-hydrolysed PVA, titanium dioxide, macrogol 3350 and talc, with optional colouring such as iron oxide or indigo carmine or iron oxide yellow or FD& C yellow #6). The amount of coating will generally be between about 1-8% of the uncoated tablet’s weight. In some embodiments, the amount of coating will generally be between about 2-6% of the uncoated tablet’s weight. In some embodiments, the amount of coating will generally be between about 3-4% of the uncoated tablet’s weight.

[0157] In some embodiments, the amount of coating is 1% of the uncoated tablet’s weight. In some embodiments, the amount of coating is 2% of the uncoated tablet’s weight. In some embodiments, the amount of coating is 3% of the uncoated tablet’s weight. In some embodiments, the amount of coating is 4% of the uncoated tablet’s weight. In some embodiments, the amount of coating is 5% of the uncoated tablet’s weight. In some embodiments, the amount of coating is 6% of the uncoated tablet’s weight. In some1592-US-NP / WO-PCT embodiments, the amount of coating is 7% of the uncoated tablet’s weight. In some embodiments, the amount of coating is 8% of the uncoated tablet’s weight.

[0158] In some embodiments, the coating is Opadry II White 85F 18422. Opadry II White 85F18422 contains: 40.00% w / w Polyvinyl Alcohol, 25.00% w / w Titanium Dioxide, 20.20% w / w Macrogol / PEG 3350, and 14.80% w / w Talc.

[0159] In some embodiments, the coating is Opadry II Grey 85F575019. Opadry II Grey 85F575019 contains: 40.00% w / w Polyvinyl Alcohol, 23.80% w / w Titanium Dioxide, 20.20% w / w Macrogol / PEG 3350, 14.80% w / w Talc, and 1.20% w / w Black Iron Oxide.Methods of Use

[0160] In some embodiments, the methods provided herein comprise preventing a human immunodeficiency virus (HIV) infection in the patient. In some embodiments, the patient may be at risk of contracting an HIV infection. In some embodiments, the patient has been identified as an individual who is at risk of sexual transmission of HIV. In some embodiments, the individual has been identified as a man (e.g., who has sexual intercourse with a man or a woman), transgender man, transgender woman, a woman (e.g., who has sexual intercourse with a man or a woman), as a gender non-binary individual (e.g., who has sexual intercourse with a man or a woman), and / or a sex worker.

[0161] As used herein, an “at risk” individual is an individual who is at risk of developing a condition to be treated. An individual “at risk” may or may not have detectable disease or condition, and may or may not have displayed detectable disease prior to the methods described herein. “At risk” denotes that an individual has one or more so-called risk factors, which are measurable parameters that correlate with development of a disease or condition and are known in the art. An individual having one or more of these risk factors has a higher probability of developing the disease or condition than an individual without these risk factor(s). For example, individuals at risk for AIDS are those having HIV.In some embodiments, the individual has been identified as one or more of the following:• having sex with partners of unknown HIV status;• having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load;• having sex in a geographic area where HIV is common;• having sex while under the influence of substances or alcohol;• not using condoms consistently with partners of unknown status; and1592-US-NP / WO-PCT • an individual who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Non-limiting examples of opioids include fentanyl and heroin. Non-limiting examples of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0162] In some embodiments, the individual has been identified as having sex with partners of unknown HIV status.

[0163] In some embodiments, the individual has been identified as having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load.

[0164] In some embodiments, the individual has been identified as having sex in a geographic area where HIV is common.

[0165] In some embodiments, the individual has been identified as having sex in a geographic area of North America (e.g., United States, Canada, Mexico) where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of the United States where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of the Canada where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of the Mexico where HIV is common.

[0166] In some embodiments, the individual has been identified as having sex in a geographic area of Africa where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of South Africa where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of Uganda where HIV is common.

[0167] In some embodiments, the individual has been identified as having sex in a geographic area of Europe where HIV is common.

[0168] In some embodiments, the individual has been identified as having sex in a geographic area of Asia (e.g., Thailand) where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of Thailand where HIV is common.

[0169] In some embodiments, the individual has been identified as having sex in a geographic area of South America (e.g., Argentina, Brazil, Peru, and the like) where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of Argentina where HIV is common. In some embodiments, the individual has been identified as having sex in a geographic area of Brazil where HIV is common. In some1592-US-NP / WO-PCT embodiments, the individual has been identified as having sex in a geographic area of Peru where HIV is common.

[0170] In some embodiments, the individual has been identified as having sex while under the influence of substances or alcohol.

[0171] In some embodiments, the individual has been identified as not using condoms consistently with partners of unknown status.

[0172] In some embodiments, the individual has been identified as an individual who injects drugs.

[0173] In some embodiments, the individual is a cisgender woman. In some embodiments, the individual is an adolescent cisgender woman. In some embodiments, the adolescent cisgender woman is about 16 to about 25 years of age, for example, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, or about 26 years of age.

[0174] In some embodiments, the individual is a cisgender woman identified as one or more of the following:• having sex with partners of unknown HIV status;• having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load;• having sex in a geographic area where HIV is common;• having sex while under the influence of substances or alcohol;• not using condoms consistently with partners of unknown status; and• an individual who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Non-limiting examples of opioids include fentanyl and heroin. Non-limiting examples of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0175] In some embodiments, the individual is a cisgender woman identified as having sex with partners of unknown HIV status.

[0176] In some embodiments, the individual is a cisgender woman identified as having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load.

[0177] In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area where HIV is common.1592-US-NP / WO-PCT

[0178] In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of North America (e.g., United States, Canada, Mexico) where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of the United States where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of the Canada where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of the Mexico where HIV is common.

[0179] In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Africa where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of South Africa where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Uganda where HIV is common.

[0180] In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Europe where HIV is common.

[0181] In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Asia (e.g., Thailand) where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Thailand where HIV is common.

[0182] In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of South America (e.g., Argentina, Brazil, Peru, and the like) where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Argentina where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Brazil where HIV is common. In some embodiments, the individual is a cisgender woman identified as having sex in a geographic area of Peru where HIV is common.

[0183] In some embodiments, the individual is a cisgender woman identified as having sex while under the influence of substances or alcohol.

[0184] In some embodiments, the individual is a cisgender woman identified as not using condoms consistently with partners of unknown status.

[0185] In some embodiments, the individual is a cisgender woman identified as an individual who injects drugs.

[0186] In some embodiments, the individual is a transgender woman. In some embodiments, the individual is an adolescent transgender woman. In some embodiments, the adolescent transgender woman is about 16 to about 25 years of age, for example, about 16, about 17, about1592-US-NP / WO-PCT 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, or about 26 years of age.

[0187] In some embodiments, the individual is a transgender woman identified as one or more of the following:• having sex with partners of unknown HIV status;• having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load;• having sex in a geographic area where HIV is common;• having sex while under the influence of substances or alcohol;• not using condoms consistently with partners of unknown status; and• an individual who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Non-limiting examples of opioids include fentanyl and heroin. Non-limiting examples of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0188] In some embodiments, the individual is a transgender woman identified as having sex with partners of unknown HIV status.

[0189] In some embodiments, the individual is a transgender woman identified as having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load.

[0190] In some embodiments, the individual is a transgender woman identified as having sex in a geographic area where HIV is common.

[0191] In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of North America (e.g., United States, Canada, Mexico) where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of the United States where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of the Canada where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of the Mexico where HIV is common.

[0192] In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Africa where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of South Africa where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Uganda where HIV is common.1592-US-NP / WO-PCT

[0193] In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Europe where HIV is common.

[0194] In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Asia (e.g., Thailand) where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Thailand where HIV is common.

[0195] In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of South America (e.g., Argentina, Brazil, Peru, and the like) where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Argentina where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Brazil where HIV is common. In some embodiments, the individual is a transgender woman identified as having sex in a geographic area of Peru where HIV is common.

[0196] In some embodiments, the individual is a transgender woman identified as having sex while under the influence of substances or alcohol.

[0197] In some embodiments, the individual is a transgender woman identified as not using condoms consistently with partners of unknown status.

[0198] In some embodiments, the individual is a transgender woman identified as an individual who injects drugs.

[0199] In some embodiments, the individual is a cisgender man. In some embodiments, the individual is an adolescent cisgender man. In some embodiments, the adolescent cisgender man is about 16 to about 25 years of age, for example, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, or about 26 years of age.

[0200] In some embodiments, the individual is a cisgender man identified as one or more of the following:• having sex with partners of unknown HIV status;• having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load;• having sex in a geographic area where HIV is common;• having sex while under the influence of substances or alcohol;• not using condoms consistently with partners of unknown status; and• an individual who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Non-limiting examples of opioids include fentanyl and heroin. Non-limiting examples1592-US-NP / WO-PCT of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0201] In some embodiments, the individual is a cisgender man identified as having sex with partners of unknown HIV status.

[0202] In some embodiments, the individual is a cisgender man identified as having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load.

[0203] In some embodiments, the individual is a cisgender man identified as having sex in a geographic area where HIV is common.

[0204] In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of North America (e.g., United States, Canada, Mexico) where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of the United States where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of the Canada where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of the Mexico where HIV is common.

[0205] In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Africa where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of South Africa where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Uganda where HIV is common.

[0206] In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Europe where HIV is common.

[0207] In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Asia (e.g., Thailand) where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Thailand where HIV is common.

[0208] In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of South America (e.g., Argentina, Brazil, Peru, and the like) where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Argentina where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Brazil where HIV is common. In some embodiments, the individual is a cisgender man identified as having sex in a geographic area of Peru where HIV is common.1592-US-NP / WO-PCT

[0209] In some embodiments, the individual is a cisgender man identified as having sex while under the influence of substances or alcohol.

[0210] In some embodiments, the individual is a cisgender man identified as not using condoms consistently with partners of unknown status.

[0211] In some embodiments, the individual is a cisgender man identified as an individual who injects drugs.

[0212] In some embodiments, the individual is a transgender man. In some embodiments, the individual is an adolescent transgender man. In some embodiments, the adolescent transgender man is about 16 to about 25 years of age, for example, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, or about 26 years of age.

[0213] In some embodiments, the individual is a transgender man identified as one or more of the following:• having sex with partners of unknown HIV status;• having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load;• having sex in a geographic area where HIV is common;• having sex while under the influence of substances or alcohol;• not using condoms consistently with partners of unknown status; andan individual who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Non-limiting examples of opioids include fentanyl and heroin. Non-limiting examples of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0214] In some embodiments, the individual is a transgender man identified as having sex with partners of unknown HIV status.

[0215] In some embodiments, the individual is a transgender man identified as having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load.

[0216] In some embodiments, the individual is a transgender man identified as having sex in a geographic area where HIV is common.

[0217] In some embodiments, the individual is a transgender man identified as having sex in a geographic area of North America (e.g., United States, Canada, Mexico) where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of the United States where HIV is common. In some embodiments, the1592-US-NP / WO-PCT individual is a transgender man identified as having sex in a geographic area of the Canada where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of the Mexico where HIV is common.

[0218] In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Africa where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of South Africa where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Uganda where HIV is common.

[0219] In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Europe where HIV is common.

[0220] In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Asia (e.g., Thailand) where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Thailand where HIV is common.

[0221] In some embodiments, the individual is a transgender man identified as having sex in a geographic area of South America (e.g., Argentina, Brazil, Peru, and the like) where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Argentina where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Brazil where HIV is common. In some embodiments, the individual is a transgender man identified as having sex in a geographic area of Peru where HIV is common.

[0222] In some embodiments, the individual is a transgender man identified as having sex while under the influence of substances or alcohol.

[0223] In some embodiments, the individual is a transgender man identified as not using condoms consistently with partners of unknown status.

[0224] In some embodiments, the individual is a transgender man identified as an individual who injects drugs.

[0225] In some embodiments, the individual is a gender non-binary individual. In some embodiments, the individual is an adolescent gender non-binary individual. In some embodiments, the adolescent gender non-binary individual is about 16 to about 25 years of age, for example, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, or about 26 years of age.

[0226] In some embodiments, the individual is a gender non-binary individual identified as one or more of the following:1592-US-NP / WO-PCT • having sex with partners of unknown HIV status;• having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load;• having sex in a geographic area where HIV is common;• having sex while under the influence of substances or alcohol;• not using condoms consistently with partners of unknown status; and• an individual who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Non-limiting examples of opioids include fentanyl and heroin. Non-limiting examples of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0227] In some embodiments, the individual is a gender non-binary individual identified as having sex with partners of unknown HIV status.

[0228] In some embodiments, the individual is a gender non-binary individual identified as having sex with people who are living with HIV but not on HIV treatment and with an undetectable viral load.

[0229] In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area where HIV is common.

[0230] In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of North America (e.g., United States, Canada, Mexico) where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of the United States where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of the Canada where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of the Mexico where HIV is common.

[0231] In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Africa where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of South Africa where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Uganda where HIV is common.

[0232] In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Europe where HIV is common.1592-US-NP / WO-PCT

[0233] In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Asia (e.g., Thailand) where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Thailand where HIV is common.

[0234] In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of South America (e.g., Argentina, Brazil, Peru, and the like) where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Argentina where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Brazil where HIV is common. In some embodiments, the individual is a gender non-binary individual identified as having sex in a geographic area of Peru where HIV is common.

[0235] In some embodiments, the individual is a gender non-binary individual identified as having sex while under the influence of substances or alcohol.

[0236] In some embodiments, the individual is a gender non-binary individual identified as not using condoms consistently with partners of unknown status.

[0237] In some embodiments, the individual is a gender non-binary individual identified as an individual who injects drugs.In some embodiments, the individual has been identified as:• having anal sex with at least two different sexual partners and no consistent condom use over the last 6 months; and / or• having history of sexually transmitted diseases (STDs) during the last 12 months (e.g., syphilis, gonorrhea, chlamydiae, HBV or HCV infection); and / or• using psycho-active drugs during sexual intercourses (e.g., cocaine, gammahydroxybutyric acid (GHB), methylenedioxymethamphetamine (MDMA), mephedrone); and / or• having sexual intercourse with one or more partners originating from a region with high prevalence of HIV infection (> 1%) (e.g., South America, Sub-Saharan Africa, South- East Asia, Eastern Europe, French Guyana) and no consistent condom use; and / or • a sex worker; and / or• having a sexual partner who is an intravenous drug user sharing injection material; and / or• having an HIV-infected sexual partner with a detectable plasma viral load (e.g., >50 copies (cp) / milliliter (mL)); and / or1592-US-NP / WO-PCT • a cisgender man;• a transgender man;• a cisgender woman;• a transgender woman;• a gender non-binary individual; and / or• a person who injects drugs, including, for example, but not limited to people who inject opioids, stimulants, psychoactive drugs, or a combination of any of the foregoing. Nonlimiting examples of opioids include fentanyl and heroin. Non-limiting examples of stimulants include cocaine and amphetamines. Non-limiting examples of psychoactive drugs include benzodiazepines.

[0238] In some embodiments, the methods provided herein comprise administering to the patient a prophylactic ally effective amount of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and a compound of Formula II, or a pharmaceutically acceptable salt thereof, for pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV-1 in adults and adolescents. In some embodiments, the methods provided herein comprise administering to the patient a prophylactically effective amount of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and a compound of Formula II, or a pharmaceutically acceptable salt thereof, for pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg. In some embodiments, the patient has obtained a negative HIV-1 test prior to administration of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, and a compound of Formula II, or a pharmaceutically acceptable salt thereof.

[0239] In some embodiments, the patient is HIV-negative. In some embodiments, the HIV is HIV-1. In some embodiments, the HIV is HIV-2. In some embodiments, the HIV is HIV-1 and HIV-2.

[0240] As used herein, “HIV” or “Human Immunodeficiency Virus” refers to HIV-1 and / or to HIV-2.

[0241] The term “patient” is meant to refer to a human who is in need of preventative treatment for a viral infection, such as HIV infection.

[0242] As used herein, the terms “prevention” or “preventing” refer to the administration of a compound, or a pharmaceutically acceptable salt or free acid form thereof, or composition comprising the compound, pharmaceutically acceptable salt, or free acid form thereof according to the present disclosure pre- or post-exposure of the patient to the virus but before the appearance of symptoms of the disease, and / or prior to the detection of the virus in the blood.1592-US-NP / WO-PCT The terms also refer to prevention of the appearance of symptoms of the disease and / or to prevent the virus from reaching detectable levels in the blood. The terms include both preexposure prophylaxis (PrEP), as well as post-exposure prophylaxis (PEP) and event driven or “on demand” prophylaxis. The terms also refer to prevention of perinatal transmission of HIV from mother to baby by administration of a compound, pharmaceutically acceptable salt thereof, or composition comprising the compound or the pharmaceutically acceptable salt thereof according to the present disclosure to the mother before giving birth and to the child within the first days of life. The term also refers to prevention of transmission of HIV through blood transfusion.

[0243] As used herein, the term “period of exposure” refers to a period of time, ranging from a single event or to multiple events over an extended period of time, in which a patient is exposed to HIV. For example, a patient who engages in one sexual intercourse event with a partner who is HIV-positive has a period of exposure that is limited to the time and duration of that one sexual intercourse event with that partner. As another example, a patient who has sexual intercourse with a partner who is HIV-positive on multiple occasions over an extended period of time (e.g., days, weeks, months, or years) has a period of exposure that ranges from the first instance to the last instance of sexual intercourse with that partner.

[0244] In some embodiments, the methods disclosed herein may comprise event driven administration of a composition provided herein (e.g., a composition comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof), to the patient. As used herein, the terms “event driven” or “event driven administration” refer to administration of a composition provided herein, (1) prior to an event (e.g., 2 hours, 1 day, 2 days, 5 days, 7 days, 10 days, 14 days, 28 days (i.e., one month), or more days prior to the event) that would expose the patient to HIV (or that would otherwise increase the patient’s risk of acquiring HIV); and / or (2) during an event (or more than one recurring event) that would expose the patient to HIV (or that would otherwise increase the patient’s risk of acquiring HIV); and / or (3) after an event (or after the final event in a series of recurring events) that would expose the patient to HIV (or that would otherwise increase the patient’s risk of acquiring HIV). In some embodiments, the event driven administration is performed pre-exposure of the patient to the HIV. In some embodiments, the event driven administration is performed during exposure of the patient to the HIV. In some embodiments, the event driven administration is performed postexposure of the patient to the HIV.

[0245] In some embodiments, the event driven administration is performed pre-exposure of the patient to the HIV and during exposure of the patient to the HIV.1592-US-NP / WO-PCT

[0246] In some embodiments, the event driven administration is performed pre-exposure of the patient to the HIV and post-exposure of the patient to the HIV.

[0247] In some embodiments, the event driven administration is performed during exposure of the patient to the HIV and post-exposure of the patient to the HIV.

[0248] In certain embodiments, the methods disclosed herein involve administration prior to and / or after an event that would expose the patient to HIV or that would otherwise increase the patient’s risk of acquiring HIV, e.g., as pre-exposure prophylaxis (PrEP) and / or as post-exposure prophylaxis (PEP). Examples of events that could increase a patient’s risk of acquiring HIV include, without limitation, no condom use during anal intercourse with an HIV positive partner or a partner of unknown HIV status; anal intercourse with more than 3 sexual partners; exchange of money, gifts, shelter or drugs for anal sex; sex with male partner and diagnosis of sexually transmitted infection; and no consistent use of condoms with a sexual partner known to be HIV positive. In some embodiments, the methods disclosed herein comprise pre-exposure prophylaxis (PrEP). In some embodiments, methods disclosed herein comprise post-exposure prophylaxis (PEP). In some embodiments, the methods disclosed herein comprise pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

[0249] In some embodiments, a composition provided herein is administered before exposure of the patient to the HIV.

[0250] In some embodiments, a composition provided herein is administered during the period of exposure of the patient to the HIV.

[0251] In some embodiments, a composition provided herein is administered after final exposure of the patient to the HIV.

[0252] In some embodiments, a composition provided herein is administered before and during exposure of the patient to the HIV.

[0253] In some embodiments, a composition provided herein is administered before and after exposure of the patient to the HIV.

[0254] In some embodiments, a composition provided herein is administered during and after exposure of the patient to the HIV.

[0255] In some embodiments, a composition provided herein is administered before, during, and after exposure of the patient to the HIV.

[0256] In some embodiments, the dose of the composition administered during each period (z.e., before, during, and after exposure) may be different, i.e, independently selected from any of the doses disclosed herein.1592-US-NP / WO-PCT

[0257] In certain embodiments, e.g., when administered as PrEP, a composition provided herein is administered 1 hour to 240 hours (z.e., within 10 days), 1 hour to 216 hours, 1 hour to 192 hours, 1 hour to 168 hours, 1 hour to 144 hours, 1 hour to 120 hours, 1 hour to 96 hours, 1 hour to 72 hours, 1 hour to 48 hours, 1 hour to 24 hours, or 1 hour to 12 hours prior to an event that would increase the patient’s risk of acquiring HIV (e.g., prior to sexual activity, prior to sexual intercourse or other exposure to the HIV). In some embodiments, a composition provided herein is administered within 14 days, 13 days, 12 days, 11 days, 10 days, 9 days, 8 days, 7 days, 6 days, 5 days, 4 days, 3 days, 2 days, or 1 day prior to an event that would increase the patient’s risk of acquiring HIV (e.g., prior to sexual intercourse or other exposure to the HIV). In some embodiments, a composition provided herein is administered within 72 hours, 60 hours, 48 hours, 24 hours, 12 hours, 9 hours, 6 hours, 4 hours, 3 hours, 2 hours, or 1 hour prior to an event that would increase the patient’s risk of acquiring HIV (e.g., prior to sexual intercourse or other exposure to the HIV). In certain embodiments, when a composition provided herein is administered prior to an event that would increase the patient’s risk of acquiring HIV, it is administered daily prior to the event (e.g., sexual activity). In certain embodiments, when a composition provided herein is administered prior to an event that would increase the patient’s risk of acquiring HIV, it is administered one to three times prior to the event. In certain embodiments, when a composition provided herein is administered prior to an event that would increase the patient’s risk of acquiring HIV, it is administered one time (i.e., once) prior to the event.

[0258] In some embodiments, a composition provided herein is administered once from about 31 days to about one day before exposure of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 30 days to about one day before exposure of the patient to the HIV. In some embodiments, a composition provided herein is administered from about 14 days to about one day before exposure of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 14 days to about one day before exposure of the patient to the HIV.

[0259] In some embodiments, a composition provided herein is administered from about 10 days to about 5 days before exposure of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 10 days to about 5 days before exposure of the patient to the HIV.

[0260] In some embodiments, a composition provided herein is administered from about 8 days to about 6 days before exposure of the patient to the HIV. In some embodiments, a1592-US-NP / WO-PCT composition provided herein is administered once from about 8 days to about 6 days before exposure of the patient to the HIV.

[0261] In some embodiments, a composition provided herein is administered about 7 days before exposure of the patient to the HIV. In some embodiments, a composition provided herein is administered once about 7 days before exposure of the patient to the HIV.

[0262] In some embodiments, a composition provided herein is administered from about 72 hours to about 1 hour before exposure of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 72 hours to about 1 hour before exposure of the patient to the HIV.

[0263] In some embodiments of the methods provided herein, the pre-exposure prophylaxis (PrEP) comprises continuous PrEP.

[0264] In certain embodiments where a composition provided herein is administered before exposure of the patient to the HIV, the methods disclosed herein further comprise administering one or more additional doses of the compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof, during, and / or after exposure of the patient to the HIV.

[0265] In some embodiments, e.g., when administered as part of a PrEP regimen or as part of a PEP regimen, a composition provided herein is administered during the period of exposure of the patient to the HIV. In certain embodiments wherein a composition provided herein is administered before HIV exposure, the composition is administered about every 7 days, about every 14 days, about every 21 days, about every 28 days, about every 35 days, about every 42 days, or about every 6 months, or about every 12 months (e.g., as a single dose) during the time of HIV exposure (e.g., during the time period of sexual activity with a sexual partner known to be HIV positive). In some embodiments, a composition provided herein is administered once about every 7 days, about every 14 days, about every 21 days, about every 28 days, about every 35 days, about every 42 days, about every 6 months, or about every 12 months during the period of exposure of the patient to the HIV.

[0266] In some embodiments, a composition provided herein administered prior to exposure to the HIV is at a different dose than a composition (e.g., a composition comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) administered during and / or after exposure to the HIV. For example, in some embodiments, the dose of the compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof, is increased, e.g., as a double dose, as a triple dose, and the like as compared to an earlier administered dose (e.g., a dose prior to exposure to the HIV). In some embodiments, the increased dose of the compound of Formula la or lb, or a pharmaceutically acceptable salt or1592-US-NP / WO-PCT free acid form thereof, is a double dose. In some embodiments, the dose of the compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof, is decreased, e.g., a half dose as compared to an earlier administered dose (e.g., a dose prior to exposure to the HIV).

[0267] In some embodiments, a composition provided herein (e.g., a composition comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is administered as a single dose from about 1 hour to about 10 days before exposure of the patient to the HIV.

[0268] Additional examples of PrEP and / or PEP can be found, for example, at the clinical trial summary titled “On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men” (Clinical Trial # NCTO 1473472); the clinical trial summary titled “Prevention of HIV in ile-de-France” (Clinical Trials # NCT03113123), and at Molina et al, N. Engl. J. Med. 2015, 353:2237-2246, the disclosure of each of which is incorporated herein by reference in its entirety.

[0269] In some embodiments, e.g., when administered as part of a PrEP regimen or as part of a PEP regimen, a composition provided herein is administered 1 hour to 10 days, 1 hour to 7 days, 1 hour to 5 days, 1 to 72 hours, 1 to 48 hours, 1 to 36 hours, 1 to 24 hours, or 1 to 12 hours following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV).

[0270] In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered for 7 days, 14 days, 21 days, 28 days, 30 days, or 45 days following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered for 30 days following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, a composition provided herein is administered less than 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 12 hours, 18 hours, 24 hours, 36 hours, or 48 hours following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV virus). In certain embodiments, a composition provided herein is administered for 1 day, 2 days, 3 days, 4 days, or 5 days following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’s risk of acquiring HIV, it is administered daily following the event. In certain embodiments, when a1592-US-NP / WO-PCT composition provided herein is administered following an event that would increase the patient’s risk of acquiring HIV, it is administered one to three times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’ s risk of acquiring HIV, it is administered once following the event.

[0271] In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every week, once about every month, once about every 2 months, once about every 3 months, once about every 4 months, once about every 5 months, once about every 6 months, or once about every 12 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every week following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every month following an event that would increase the patient’ s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every 2 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every 3 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every 4 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every 5 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every 6 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered once about every 12 months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV).1592-US-NP / WO-PCT

[0272] In certain embodiments, e.g., when administered as PEP, a composition provided herein is administered for one month, two months, three months, four months, five months, six months, or twelve months following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV).

[0273] In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’ s risk of acquiring HIV, it is administered one to fifty times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’ s risk of acquiring HIV, it is administered one to forty times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’s risk of acquiring HIV, it is administered one to thirty times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’ s risk of acquiring HIV, it is administered one to twenty times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’s risk of acquiring HIV, it is administered one to fifteen times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’s risk of acquiring HIV, it is administered one to ten times following the event. In certain embodiments, when a composition provided herein is administered following an event that would increase the patient’ s risk of acquiring HIV, it is administered one to five times following the event.

[0274] In some embodiments, a composition provided herein is administered during exposure of the patient to the HIV (e.g., during a period of sexual activity with a sexual partner known to be HIV positive).

[0275] In some embodiments, a composition provided herein is administered after exposure (e.g., after final exposure) of the patient to the HIV (e.g., after a period of sexual activity with a sexual partner known to be HIV positive). In some embodiments, a composition provided herein is administered from about 1 hour to about 14 days after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 1 hour to about 14 days after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered from about 1 hour to about 7 days after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 1 hour to about 7 days after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a1592-US-NP / WO-PCT composition provided herein is administered from about 1 hour to about 72 hours after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 1 hour to about 72 hours after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered from about 1 hour to about 24 hours after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 1 hour to about 24 hours after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered from about 24 hours to about 72 hours after exposure (e.g., after final exposure) of the patient to the HIV. In some embodiments, a composition provided herein is administered once from about 24 hours to about 72 hours after exposure (e.g., after final exposure) of the patient to the HIV.

[0276] In some embodiments, e.g., when administered as PrEP, a composition provided herein is administered prior to an event that would increase the patient’ s risk of acquiring HIV (e.g., prior to sexual activity), and following the event. For example, in certain embodiments, when administered as PrEP, a composition provided herein is administered 1 to 240 hours (i.e., within 10 days), 1 hour to 216 hours, 1 hour to 192 hours, 1 hour to 168 hours, 1 hour to 144 hours, 1 hour to 120 hours, 1 hour to 96 hours, 1 hour to 72 hours, 1 hour to 48 hours, 1 hour to 24 hours, or 1 hour to 12 hours prior to an event that would increase the patient’s risk of acquiring HIV (e.g., prior to sexual activity) and 1 hour to 240 hours (i.e., within 10 days), 1 hour to 216 hours, 1 hour to 192 hours, 1 hour to 168 hours, 1 hour to 144 hours, 1 hour to 120 hours, 1 hour to 96 hours, 1 hour to 72 hours, 1 hour to 48 hours, 1 hour to 36 hours, 1 hour to 24 hours, or 1 hour to 12 hours following the event. For example, in some embodiments, one or more (e.g., one, two, or three) dosages of a composition provided herein are administered one to ten days (e.g., seven days) prior to an event that would increase the patient’s risk of acquiring HIV (e.g., prior to sexual intercourse) and once during a period of one to ten days following the event. In some embodiments, a composition provided herein is administered once per week, twice per week, three times per week, four times per week, or five times per week and one or more times (e.g., one, two, or three times) beginning 1 to 48 hours following an event that would increase the patient’s risk of acquiring HIV (e.g., following sexual intercourse).

[0277] Also provided herein is a method of reducing the risk of acquiring HIV in a patient, comprising administering to the patient a composition provided herein (e.g., a composition comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof).1592-US-NP / WO-PCT

[0278] In some embodiments, methods for reducing the risk of acquiring HIV (e.g., HIV-1 and / or HIV-2) comprise administration of a composition provided herein to a patient in combination with safer sexual intercourse practices. In certain embodiments, methods for reducing the risk of acquiring HIV (e.g., HIV-1 and / or HIV-2) comprise administration of a composition provided herein to a patient at risk of acquiring HIV. Examples of patients at high risk for acquiring HIV include, without limitation, a patient who is at risk of sexual transmission of HIV.

[0279] In some embodiments, the reduction in risk of acquiring HIV is at least about 40%, 50%, 60%, 70%, 80%, 90%, or 95% (compared to a patient having not been administered the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof according to any of the methods provided herein). In some embodiments, the reduction in risk of acquiring HIV is about 80%, 85%, or 90%. In some embodiments, the reduction in risk of acquiring HIV is at least about 75%. In some embodiments, the reduction in risk of acquiring HIV is at least about 80%. In some embodiments, the reduction in risk of acquiring HIV is at least about 85%. In some embodiments, the reduction in risk of acquiring HIV is at least about 90%.

[0280] In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is suitable for oral administration. In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is administered orally.

[0281] In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is administered once every five to ten days, for example, once every five days, six days, seven days, eight days, nine days, or ten days. In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is administered once every six to eight days. In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is administered once every seven days (i.e., once- weekly).

[0282] In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is orally administered once every five to ten days, for example, once every five days, six days, seven days, eight days, nine days, or ten days. In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically1592-US-NP / WO-PCT acceptable salt or free acid form thereof) is orally administered once every six to eight days. In some embodiments, a composition provided herein (e.g., a tablet comprising a compound of Formula la or lb, or a pharmaceutically acceptable salt or free acid form thereof) is orally administered once every seven days (i.e., once- weekly).

[0283] In some embodiments, the method comprises administering to the patient a tablet comprising or consists essentially of:about 30 w / w% to about 80 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 0 w / w% to about 30 w / w% of mannitol;about 10 w / w% to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0284] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50 w / w% to about 70 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 25 w / w% to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0285] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0286] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55 w / w% to about 65 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 25 w / w% to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0287] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0288] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:1592-US-NP / WO-PCT about 60 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 28.5 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0289] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof;about 28 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0290] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0291] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30to about 80of the free acid form of the compound of Formula la or lb;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0292] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50to about 70of the free acid form of the compound of Formula la or lb;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0293] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55to about 65 of the free acid form of the compound of Formula la or lb;1592-US-NP / WO-PCT about 25 w’ / w’^c to about 30 w’ / w’^c of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0294] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the free acid form of the compound of Formula la or lb; about 28.5 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0295] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the free acid form of the compound of Formula la or lb; about 28 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0296] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30to about 80of an amorphous form of the free acid form of the compound of Formula la or lb;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0297] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50to about 70of an amorphous form of the free acid form of the compound of Formula la or lb;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0298] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:1592-US-NP / WO-PCT about 55 w / w% to about 65 w / w% of an amorphous form of the free acid form of the compound of Formula la or lb;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0299] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la or lb;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0300] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la or lb;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0301] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30to about 80 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0302] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50to about 70 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; and1592-US-NP / WO-PCT about 1 w / w% to about 5 w / w% of magnesium stearate.

[0303] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55to about 65 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0304] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0305] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0306] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30 w / w% to about 80 w / w% of the free acid form of the compound of Formula la; about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0307] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50to about 70 of the free acid form of the compound of Formula la; about 25to about 35 w / w% of microcrystalline cellulose;1592-US-NP / WO-PCT about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0308] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55 w / w% to about 65 w / w% of the free acid form of the compound of Formula la; about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0309] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60of the free acid form of the compound of Formula la;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0310] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60of the free acid form of the compound of Formula la;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0311] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30to about 80of an amorphous form of the free acid form of the compound of Formula la;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0312] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50to about 70 of an amorphous form of the free acid form of the compound of Formula la;about 25to about 35 w / w% of microcrystalline cellulose;1592-US-NP / WO-PCT about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0313] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55to about 65of an amorphous form of the free acid form of the compound of Formula la;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0314] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0315] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60of an amorphous form of the free acid form of the compound of Formula la;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0316] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30 w / w% to about 80 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0317] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:1592-US-NP / WO-PCT about 50 w / w% to about 70 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0318] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0319] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55to about 65of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0320] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0321] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 28.5of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0322] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the compound of Formula lb, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0323] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0324] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:1592-US-NP / WO-PCT about 30 w / w% to about 80 w’ / w’^c of the free acid form of the compound of Formula lb; about 0 w / w% to about 30 w / w% of mannitol;about 10 w / w% to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0325] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0326] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50 w / w% to about 70 w / w% of the free acid form of the compound of Formula lb; about 25 w / w% to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0327] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0328] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55 w / w% to about 65 w / w% of the free acid form of the compound of Formula lb; about 25 w / w% to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0329] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0330] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the free acid form of the compound of Formula lb;about 28.5 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0331] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of the free acid form of the compound of Formula lb;about 28 w / w% of microcrystalline cellulose;1592-US-NP / WO-PCT about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

[0332] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0333] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 30to about 80of an amorphous form of the free acid form of the compound of Formula lb;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

[0334] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 50to about 70of an amorphous form of the free acid form of the compound of Formula lb;about 25to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

[0335] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0336] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 55to about 65of an amorphous form of the free acid form of the compound of Formula lb;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

[0337] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0338] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:1592-US-NP / WO-PCT about 60 w / w% of an amorphous form of the free acid form of the compound of Formula lb;about 28.5 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 1.5 w / w% of magnesium stearate.

[0339] In some embodiments, the method comprises administering to the patient a tablet comprising or consisting essentially of:about 60 w / w% of an amorphous form of the free acid form of the compound of Formula lb;about 28 w / w% of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2 w / w% of magnesium stearate.

[0340] In some embodiments, the method comprises administering said tablet once every month or once every week.

[0341] In some embodiments, about 1 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, for example, about 1 mg, about 5 mg, about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1125 mg, about 1150 mg, about 1175 mg, about 1200 mg, about 1225 mg, about 1250 mg, about 1275 mg, about 1300 mg, about 1325 mg, about 1350 mg, about 1375 mg, about 1400 mg, about 1425 mg, about 1450 mg, about 1475 mg, about 1500 mg, about 1525 mg, about 1550 mg, about 1575 mg, about 1600 mg, about 1625 mg, about 1650 mg, about 1675 mg, about 1700 mg, about 1725 mg, about 1750 mg, about 1775 mg, about 1800 mg, about 1825 mg, about 1850 mg, about 1875 mg, about 1900 mg, about 1925 mg, about 1950 mg, about 1975 mg, about 2000, about 2100 mg, about 2200 mg, about 2300 mg, about 2400 mg, about 2500 mg, about 2600 mg, about 2700 mg, about 2800 mg, about 2900 mg, about 3000 mg, about 3100 mg, about 3200 mg, about 3300 mg, about 3400 mg, about 3500 mg, about 3600 mg, about 3700 mg, about 3800 mg, about 3900 mg, about 4000 mg, about 4100 mg, about 4200 mg, about 4300 mg, about 4400 mg, about 4500 mg, about 4600 mg, about 4700 mg,1592-US-NP / WO-PCT about 4800 mg, about 4900 mg, about 5000 mg, about 5100 mg, about 5200 mg, about 5300 mg, about 5400 mg, about 5500 mg, about 5600 mg, about 5700 mg, about 5800 mg, about 5900 mg, about 6000 mg, about 6100 mg, about 6200 mg, about 6300 mg, about 6400 mg, about 6500 mg, about 6600 mg, about 6700 mg, about 6800 mg, about 6900 mg, about 7000 mg, about 7100 mg, about 7200 mg, about 7300 mg, about 7400 mg, about 7500 mg, about 7600 mg, about 7700 mg, about 7800 mg, about 7900 mg, or about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof.

[0342] In some embodiments, about 225 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 250 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 275 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 300 mg to about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof.

[0343] In some embodiments, about 300 mg to about 310 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 305 mg to about 307 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 306 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 306 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 306 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 306 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 306 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 306 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 300 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 300 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 300 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 300 mg of the free acid form of the compound of Formula lb is1592-US-NP / WO-PCT administered to a patient in need thereof. In some embodiments, about 300 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 300 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof.

[0344] In some embodiments, about 100 mg to about 500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 340 mg to about 360 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof.

[0345] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula la or lb is administered to a1592-US-NP / WO-PCT patient in need thereof. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof.

[0346] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula la is administered to a patient in need thereof.

[0347] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments,1592-US-NP / WO-PCT about 340 mg to about 360 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula lb is administered to a patient in need thereof.

[0348] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof.

[0349] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the1592-US-NP / WO-PCT compound of Formula la is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof.

[0350] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof.

[0351] In some embodiments, about 500 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of the compound of Formula la1592-US-NP / WO-PCT or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1350 mg to about 1450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 1400 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof.

[0352] In some embodiments, about 500 mg to about 8000 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1350 mg to about 1450 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1400 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof.

[0353] In some embodiments, about 500 mg to about 8000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of the free acid form of the compound of Formula la, is1592-US-NP / WO-PCT administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1350 mg to about 1450 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1400 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof.

[0354] In some embodiments, about 500 mg to about 8000 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1350 mg to about 1450 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1400 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof.

[0355] In some embodiments, about 500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1350 mg to about 1450 mg of an amorphous form of the free acid form of1592-US-NP / WO-PCT the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 1400 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof.

[0356] In some embodiments, about 500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1350 mg to about 1450 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 1400 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof.

[0357] In some embodiments, about 500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1000 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1300 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments,1592-US-NP / WO-PCT about 1350 mg to about 1450 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1375 mg to about 1425 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1390 mg to about 1400 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1395 mg to about 1405 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1399 mg to about 1401 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 1400 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof.

[0358] In some embodiments, about 2500 mg to about 3000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2790 mg to about 2810 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 2800 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof.

[0359] In some embodiments, about 2500 mg to about 3000 of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In1592-US-NP / WO-PCT some embodiments, about 2790 mg to about 2810 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2800 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof.

[0360] In some embodiments, about 2500 mg to about 3000 of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2790 mg to about 2810 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2800 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof.

[0361] In some embodiments, about 2500 mg to about 3000 of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2790 mg to about 2810 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments,1592-US-NP / WO-PCT about 2800 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof.

[0362] In some embodiments, about 2500 mg to about 3000 of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2790 mg to about 2810 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 2800 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof.

[0363] In some embodiments, about 2500 mg to about 3000 of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2790 mg to about 2810 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 2800 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof.1592-US-NP / WO-PCT

[0364] In some embodiments, about 2500 mg to about 3000 of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2700 mg to about 2900 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2750 mg to about 2950 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2775 mg to about 2925 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2790 mg to about 2810 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2795 mg to about 2805 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2799 mg to about 2801 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 2800 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof.

[0365] In some embodiments, about 6000 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 7500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof. In some embodiments, about 7000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof.1592-US-NP / WO-PCT

[0366] In some embodiments, about 6000 mg to about 8000 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 7500 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 7000 mg of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof.

[0367] In some embodiments, about 6000 mg to about 8000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 7500 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 7000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof.

[0368] In some embodiments, about 6000 mg to about 8000 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of the free acid form of the compound of Formula lb, is1592-US-NP / WO-PCT administered to a patient in need thereof. In some embodiments, about 6500 mg to about 7500 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 7000 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof.

[0369] In some embodiments, about 6000 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 7500 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof. In some embodiments, about 7000 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof.

[0370] In some embodiments, about 6000 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some1592-US-NP / WO-PCT embodiments, about 6500 mg to about 7500 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof. In some embodiments, about 7000 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof.

[0371] In some embodiments, about 6000 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6500 mg to about 7500 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6900 mg to about 7100 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6925 mg to about 7025 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6990 mg to about 7010 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6995 mg to about 7005 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 6999 mg to about 7001 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof. In some embodiments, about 7000 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof.

[0372] In some embodiments, about 1 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof once or twice every 25 to 40 days, for example, once or twice every 25, 26, 27, 28, 20, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 days.1592-US-NP / WO-PCT

[0373] In some embodiments, the methods provided herein comprise administering to the patient one or more of the tablets provided herein (e.g., administration of one tablet, two tablets, three tablets, and the like), every 25 to 40 days, for example, once or twice every 25, 26, 27, 28, 20, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 days.

[0374] In some embodiments, the methods provided herein comprise administering to the patient one or more of the tablets provided herein (e.g., administration of one tablet, two tablets, three tablets, and the like), once or twice every 25 to 40 days, for example, once or twice every 25, 26, 27, 28, 20, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 days.

[0375] In some embodiments, about 225 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 275 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0376] In some embodiments, about 300 mg to about 310 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 305 mg to about 307 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 306 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 306 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 306 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 306 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 306 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 306 mg of an amorphous form of the free acid form of the compound1592-US-NP / WO-PCT of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0377] In some embodiments, about 100 mg to about 500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 325 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or1592-US-NP / WO-PCT twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0378] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0379] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to1592-US-NP / WO-PCT 40 days. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0380] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0381] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof,1592-US-NP / WO-PCT once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0382] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 325 mg1592-US-NP / WO-PCT to about 375 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0383] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days.1592-US-NP / WO-PCT

[0384] In some embodiments, about 500 mg to about 1000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 750 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 690 mg to about 710 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 700 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0385] In some embodiments, about 500 mg to about 1000 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 750 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 690 mg to about 710 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every1592-US-NP / WO-PCT 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 700 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0386] In some embodiments, about 500 mg to about 1000 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 750 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 690 mg to about 710 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 700 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0387] In some embodiments, about 500 mg to about 1000 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 750 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to1592-US-NP / WO-PCT 40 days. In some embodiments, about 690 mg to about 710 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 700 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0388] In some embodiments, about 500 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 700 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0389] In some embodiments, about 500 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg1592-US-NP / WO-PCT to about 750 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 700 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0390] In some embodiments, about 500 mg to about 1000 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 600 mg to about 750 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 650 mg to about 750 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 695 mg to about 705 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days. In some embodiments, about 699 mg to about 701 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or1592-US-NP / WO-PCT twice every 25 to 40 days. In some embodiments, about 700 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every 25 to 40 days.

[0391] In some embodiments, the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered once every 25 to 40 days. In some embodiments, the free acid form of the compound of Formula la or lb, is administered once every 25 to 40 days. In some embodiments, the free acid form of the compound of Formula la, is administered once every 25 to 40 days. In some embodiments, the free acid form of the compound of Formula lb, is administered once every 25 to 40 days. In some embodiments, an amorphous form of the free acid form of the compound of Formula la or lb, is administered once every 25 to 40 days. In some embodiments, an amorphous form of the free acid form of the compound of Formula la, is administered once every 25 to 40 days. In some embodiments, an amorphous form of the free acid form of the compound of Formula lb, is administered once every 25 to 40 days.

[0392] In some embodiments, the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered twice every 25 to 40 days. In some embodiments, the free acid form of the compound of Formula la or lb, is administered twice every 25 to 40 days. In some embodiments, the free acid form of the compound of Formula la, is administered twice every 25 to 40 days. In some embodiments, the free acid form of the compound of Formula lb, is administered twice every 25 to 40 days. In some embodiments, an amorphous form of the free acid form of the compound of Formula la or lb, is administered twice every 25 to 40 days. In some embodiments, an amorphous form of the free acid form of the compound of Formula la, is administered twice every 25 to 40 days. In some embodiments, an amorphous form of the free acid form of the compound of Formula lb, is administered twice every 25 to 40 days.

[0393] In some embodiments, about 225 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 275 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 350 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month.1592-US-NP / WO-PCT

[0394] In some embodiments, about 300 mg to about 310 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 305 mg to about 307 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 306 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 306 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 306 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 306 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 306 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 306 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.

[0395] In some embodiments, about 300 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.

[0396] In some embodiments, about 600 mg to about 800 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 600 mg to about 800 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 600 mg to about 800 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or1592-US-NP / WO-PCT twice every month. In some embodiments, about 600 mg to about 800 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 600 mg to about 800 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.

[0397] In some embodiments, about 675 mg to about 725 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 675 mg to about 725 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 675 mg to about 725 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 675 mg to about 725 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 675 mg to about 725 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.

[0398] In some embodiments, about 690 mg to about 710 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 690 mg to about 710 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 690 mg to about 710 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 690 mg to about 710 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 690 mg to about 710 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.1592-US-NP / WO-PCT

[0399] In some embodiments, about 700 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 700 mg of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 700 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 700 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 700 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 700 mg of an amorphous form of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.

[0400] In some embodiments, about 100 mg to about 500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound1592-US-NP / WO-PCT of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month.

[0401] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula Ia or Ib is administered to a patient in need thereof, once or twice every month.

[0402] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula Ia is1592-US-NP / WO-PCT administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month.

[0403] In some embodiments, about 100 mg to about 500 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 450 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound of the free acid form of the compound of Formula lb is administered to a patient in need thereof, once or twice every month.

[0404] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments,1592-US-NP / WO-PCT about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula la or lb is administered to a patient in need thereof, once or twice every month.

[0405] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula la is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of an1592-US-NP / WO-PCT amorphous form of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula Ia is administered to a patient in need thereof, once or twice every month.

[0406] In some embodiments, about 100 mg to about 500 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 475 mg of the free acid form of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 200 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 250 mg to about 450 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 300 mg to about 400 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 325 mg to about 375 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 340 mg to about 360 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 345 mg to about 355 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 349 mg to about 351 mg of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month. In some embodiments, about 350 mg of the compound of an amorphous form of the free acid form of the compound of Formula Ib is administered to a patient in need thereof, once or twice every month.

[0407] In some embodiments, about 500 mg to about 8000 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt1592-US-NP / WO-PCT thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1390 mg to about 1400 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1400 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month.

[0408] In some embodiments, about 500 mg to about 8000 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1390 mg to about 1400 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1400 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month.1592-US-NP / WO-PCT

[0409] In some embodiments, about 500 mg to about 8000 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1390 mg to about 1400 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1400 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month.

[0410] In some embodiments, about 500 mg to about 8000 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1390 mg to about 1400 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every1592-US-NP / WO-PCT month. In some embodiments, about 1400 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month.

[0411] In some embodiments, about 500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1390 mg to about 1400 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1400 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month.

[0412] In some embodiments, about 500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some1592-US-NP / WO-PCT embodiments, about 1390 mg to about 1400 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1400 mg of an amorphous form of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month.

[0413] In some embodiments, about 500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1000 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1300 mg to about 1500 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1350 mg to about 1450 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1375 mg to about 1425 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1390 mg to about 1400 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1395 mg to about 1405 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1399 mg to about 1401 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 1400 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month.

[0414] In some embodiments, about 2500 mg to about 3000 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments,1592-US-NP / WO-PCT about 2750 mg to about 2950 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of the compound of Formula Ia or Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month.

[0415] In some embodiments, about 2500 mg to about 3000 of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2750 mg to about 2950 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month.

[0416] In some embodiments, about 2500 mg to about 3000 of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every1592-US-NP / WO-PCT month. In some embodiments, about 2750 mg to about 2950 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of the free acid form of the compound of Formula Ia, is administered to a patient in need thereof, once or twice every month.

[0417] In some embodiments, about 2500 mg to about 3000 of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2750 mg to about 2950 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month.

[0418] In some embodiments, about 2500 mg to about 3000 of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of an amorphous form of the free acid form of the compound of Formula Ia or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2750 mg to about 2950 mg of an amorphous form of the free acid form of the compound of Formula Ia or1592-US-NP / WO-PCT Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of an amorphous form of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of an amorphous form of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of an amorphous form of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of an amorphous form of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of an amorphous form of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month.

[0419] In some embodiments, about 2500 mg to about 3000 of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2750 mg to about 2950 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of an amorphous form of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month.

[0420] In some embodiments, about 2500 mg to about 3000 of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2700 mg to about 2900 mg of an amorphous form of the free acid form of the compound of Formula Ib, is administered to a patient in need1592-US-NP / WO-PCT thereof, once or twice every month. In some embodiments, about 2750 mg to about 2950 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2775 mg to about 2925 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2790 mg to about 2810 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2795 mg to about 2805 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2799 mg to about 2801 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 2800 mg of an amorphous form of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month.

[0421] In some embodiments, about 6000 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 8000 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 7500 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6900 mg to about 7100 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6925 mg to about 7025 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6990 mg to about 7010 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6995 mg to about 7005 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6999 mg to about 7001 mg of the compound of Formula la or lb, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 7000 mg of the compound of Formula la or1592-US-NP / WO-PCT Ib, or a pharmaceutically acceptable salt thereof, is administered to a patient in need thereof, once or twice every month.

[0422] In some embodiments, about 6000 mg to about 8000 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 8000 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 7500 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6900 mg to about 7100 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6925 mg to about 7025 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6990 mg to about 7010 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6995 mg to about 7005 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6999 mg to about 7001 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 7000 mg of the free acid form of the compound of Formula la or Ib, is administered to a patient in need thereof, once or twice every month.

[0423] In some embodiments, about 6000 mg to about 8000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 8000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 7500 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6900 mg to about 7100 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6925 mg to about 7025 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6990 mg to about 7010 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6995 mg to about 7005 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every1592-US-NP / WO-PCT month. In some embodiments, about 6999 mg to about 7001 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 7000 mg of the free acid form of the compound of Formula la, is administered to a patient in need thereof, once or twice every month.

[0424] In some embodiments, about 6000 mg to about 8000 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 8000 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 7500 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6900 mg to about 7100 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6925 mg to about 7025 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6990 mg to about 7010 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6995 mg to about 7005 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6999 mg to about 7001 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 7000 mg of the free acid form of the compound of Formula lb, is administered to a patient in need thereof, once or twice every month.

[0425] In some embodiments, about 6000 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 8000 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6500 mg to about 7500 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6900 mg to about 7100 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6925 mg to about 7025 mg of an amorphous form of the free acid form of the compound of Formula la or lb, is administered to a patient in need thereof, once or twice every month. In some embodiments, about 6990 mg to about 7010 mg of1592-US...

Claims

1. 1592-US-NP / WO-PCTWHAT IS CLAIMED IS:

1. A tablet comprising a compound of Formula la:or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients.

2. The tablet of claim 1, wherein the tablet comprises about 30 w’ / w’^c to about 80 w’ / w’^c of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

3. The tablet of claim 1, wherein the tablet comprises about 55 w / w% to about 65 w’ / w’^c of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

4. The tablet of claim 1, wherein the tablet comprises about 60of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

5. The tablet of any one of claims 1 to 4, wherein the tablet comprises about 20to about 55 of one or more fillers, about 1to 15 of one or more disintegrants, and about 1 to 5 w / w% of one or more lubricants.

6. The tablet of any one of claims 1 to 5, wherein:the one or more fillers is selected from microcrystalline cellulose, mannitol, lactose monohydrate, or silicified microcrystalline cellulose;the one or more disintegrants is crospovidone; and1592-US-NP / WO-PCT the one or more lubricants is magnesium stearate.

7. The tablet of any one of claims 1 to 6, wherein the tablet comprises about 20 w / w% to about 55 w / w% of microcrystalline cellulose.

8. The tablet of any one of claims 1 to 6, wherein the tablet comprises about 25 w / w% to about 30 w / w% of microcrystalline cellulose.

9. The tablet of any one of claims 1 to 6, wherein the tablet comprises about 28 w / w% of microcrystalline cellulose.

10. The tablet of any one of claims 1 to 9, wherein the tablet comprises about 5 w / w% to about 15 w / w% of crospovidone.

11. The tablet of any one of claims 1 to 9, wherein the tablet comprises about 8 w / w% to about 12 of crospovidone.

12. The tablet of any one of claims 1 to 9, wherein the tablet comprises about 10of crospovidone.

13. The tablet of any one of claims 1 to 12, wherein the tablet comprises about 1to about 5 w / w% of magnesium stearate.

14. The tablet of any one of claims 1 to 12, wherein the tablet comprises about 1to about 3 w / w% of magnesium stearate.

15. The tablet of any one of claims 1 to 12, wherein the tablet comprises about 2of magnesium stearate.

16. The tablet of claim 1, wherein the tablet comprises:about 30to about 80 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 10to about 35 w / w% of microcrystalline cellulose;about 5 w / w% to about 15 w / w% of crospovidone; and1592-US-NP / WO-PCT about 1 w / w% to about 5 w / w% of magnesium stearate.

17. The tablet of claim 1, wherein the tablet comprises:about 55to about 65of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

18. The tablet of claim 1, wherein the tablet comprises:about 60 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

19. The tablet of any one of claims 1 to 18, wherein the tablet further comprises mannitol.

20. The tablet of any one of claims 1 to 18, wherein the tablet comprises about 10to about 30 of mannitol.

21. The tablet of any one of claims 1 to 18, wherein the tablet further comprises poloxamer 407.

22. The tablet of any one of claims 1 to 18, wherein the tablet comprises about 0.1to about 5 of poloxamer 407.

23. The tablet of claim 1, wherein the tablet comprises:about 30to about 80 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; and1592-US-NP / WO-PCT about 1 w / w% to about 5 w’ / w’^c magnesium stearate.

24. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 1 mg to about 2000 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

25. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 200 mg to about 400 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

26. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 250 mg to about 350 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

27. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 300 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

28. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 500 mg to about 1000 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

29. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 650 mg to about 750 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

30. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 700 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

31. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 800 mg to about 1000 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

32. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 850 mg to about 950 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

33. The tablet of any one of claims 1 to 23, wherein the tablet comprises about 900 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof.

34. The tablet of any one of claims 1 to 33, wherein the tablet further comprises an outer film coat.1592-US-NP / WO-PCT35. The tablet of any one of claims 1 to 34, wherein the tablet comprises the free acid form of the compound of Formula la.

36. The tablet of any one of claims 1 to 35, wherein the tablet comprises an amorphous form of the free acid form of the compound of Formula la.

37. The tablet of any one of claims 1 to 36, wherein the compound of Formula la, or a pharmaceutically acceptable salt thereof, is a compound of Formula lb:lbor a pharmaceutically acceptable salt thereof.

38. The tablet of claim 37, wherein the tablet comprises the free acid form of the compound of Formula lb.

39. The tablet of claim 37 or 38, wherein the tablet comprises an amorphous form of the free acid form of the compound of Formula lb.

40. A method of preventing human immunodeficiency virus (HIV) infection in a patient, comprising administering to the patient a tablet of any one of claims 1 to 39.

41. The method of claim 40, wherein the method comprises orally administering the tablet to the patient.1592-US-NP / WO-PCT 42. The method of claim 40 or 41, wherein the method comprises orally administering the tablet to the patient, once every month.

43. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 500 mg to about 8000 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

44. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 1300 mg to about 1500 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

45. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 1350 mg to about 1450 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

46. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 1400 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

47. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 6900 mg to about 7100 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

48. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 6950 mg to about 7050 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

49. The method of any one of claims 40 to 42, wherein the method comprises orally administering about 7000 mg of the compound of Formula la, or a pharmaceutically acceptable salt thereof to the patient, once every month.

50. The method of any one of claims 40 to 49, wherein the method comprises administering to the patient a tablet comprising:1592-US-NP / WO-PCT about 30 w / w% to about 80 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone; andabout 1 w / w% to about 5 w / w% of magnesium stearate.

51. The method of any one of claims 40 to 49, wherein the method comprises administering to the patient a tablet comprising:about 55to about 65of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 25to about 30 w / w% of microcrystalline cellulose;about 8 w / w% to about 12 w / w% of crospovidone; andabout 1 w / w% to about 3 w / w% of magnesium stearate.

52. The method of any one of claims 40 to 49, wherein the method comprises administering to the patient a tablet comprising:about 60 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 28of microcrystalline cellulose;about 10 w / w% of crospovidone; andabout 2of magnesium stearate.

53. The method of any one of claims 40 to 52, wherein the tablet further comprises mannitol.

54. The method of any one of claims 40 to 52, wherein the tablet comprises about 10to about 30 of mannitol.

55. The method of any one of claims 40 to 54, wherein the tablet further comprises poloxamer 407.

56. The method of any one of claims 40 to 54, wherein the tablet comprises about 0.1to about 5 of poloxamer 407.

57. The method of any one of claims 40 to 56, wherein the tablet comprises:1592-US-NP / WO-PCT about 30 w / w% to about 80 w / w% of the compound of Formula la, or a pharmaceutically acceptable salt thereof;about 0 to about30 of mannitol;about 10to about 35 w / w% of microcrystalline cellulose;about 1 w / w% to about 15 w / w% of crospovidone;about 0 w / w% to about 5 w / w% poloxamer 407; andabout 1 w / w% to about 5 w / w% magnesium stearate.

58. The method of any one of claims 40 to 57, which is a method of preventing a human immunodeficiency virus (HIV) infection in the patient.

59. The method of any one of claims 40 to 58, wherein the method comprises event driven administration of the tablet to the patient.

60. The method of any one of claims 40 to 59, wherein the method comprises pre-exposure prophylaxis (PrEP).

61. The method of any one of claims 40 to 59, wherein the method comprises post-exposure prophylaxis (PEP).

62. The method of any one of claims 40 to 59, wherein the method comprises pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

63. The method of claim 60 or 62, wherein the pre-exposure prophylaxis (PrEP) comprises continuous PrEP.

64. The method of any one of claims 40 to 63, wherein the tablet is administered before exposure of the patient to the HIV.

65. The method of claim 64, wherein the tablet is administered once from about 14 days to about one day before exposure of the patient to the HIV.

66. The method of claim 64, wherein the tablet is administered once from about 10 days to about 5 days before exposure of the patient to the HIV.1592-US-NP / WO-PCT67. The method of claim 64, wherein the tablet is administered once about 7 days before exposure of the patient to the HIV.

68. The method of claim 64, wherein the tablet is administered once from about 72 hours to about 1 hour before exposure of the patient to the HIV.

69. The method of any one of claims 40 to 68, comprising administering the tablet during the period of exposure of the patient to the HIV.

70. The method of any one of claims 40 to 69, comprising administering the tablet after final exposure of the patient to the HIV.

71. The method of any one of claims 40 to 70, wherein the tablet is administered as a monotherapy.

72. The method of any one of claims 40 to 71, further comprising administering to the patient a PGP inhibitor.

73. The method of claim 72, wherein the PGP inhibitor is encequidar, or a pharmaceutically acceptable salt thereof.

74. The method of claim 72 or 73, wherein the PGP inhibitor is encequidar mesylate.

75. The method of any one of claims 40 to 74, wherein the HIV is HIV-1.

76. The method of any one of claims 40 to 75, wherein the tablet comprises the free acid form of the compound of Formula la.

77. The method of any one of claims 40 to 76, wherein the tablet comprises an amorphous form of the free acid form of the compound of Formula la.1592-US-NP / WO-PCT 78. The method of any one of claims 40 to 77, wherein the compound of Formula la, or a pharmaceutically acceptable salt thereof, is a compound of Formula lb:or a pharmaceutically acceptable salt thereof.

79. The method of claim 78, wherein the tablet comprises the free acid form of the compound of Formula lb.

80. The method of claim 78 or 79, wherein the tablet comprises an amorphous form of the free acid form of the compound of Formula lb.

81. Use of a tablet of any one of claims 1 to 39, for preventing human immunodeficiency virus (HIV) in a patient.

82. The use of claim 81, further comprising administering to the patient a PGP inhibitor.

83. The use of claim 83, wherein the PGP inhibitor is encequidar, or a pharmaceutically acceptable salt thereof.

84. The use of claim 82 or 83, wherein the PGP inhibitor is encequidar mesylate.

85. A tablet of any one of claims 1 to 39, for use in therapy.

86. A tablet of any one of claims 1 to 39, for use in preventing human immunodeficiency virus (HIV) in a patient.1592-US-NP / WO-PCT87. A tablet of any one of claims 1 to 39, for use in manufacture of a medicament for preventing human immunodeficiency virus (HIV) in a patient.

88. The tablet for use according to claim 86 or 87, further comprising administering to the patient a PGP inhibitor.

89. The use of claim 88, wherein the PGP inhibitor is encequidar, or a pharmaceutically acceptable salt thereof.

90. The use of claim 88 or 89, wherein the PGP inhibitor is encequidar mesylate.

Images