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Methods for Treating HCV

A technology for patients and uses, applied in the field of treatment of HCV, can solve problems such as incomplete elimination of the virus

Pending Publication Date: 2018-08-21
ABBVIE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Efficacy and tolerability are substantially limited as many users experience side effects and elimination of virus from the body is often incomplete

Method used

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  • Methods for Treating HCV
  • Methods for Treating HCV
  • Methods for Treating HCV

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0249] Example 1: Clinical modeling of DAA combination therapy without interferon

[0250] The treatment regimen comprising administration of Compound 1 and Compound 2 uses the method described in U.S. Patent Application Publication No. 2013 / 0102526, filed October 19, 2012 and entitled "Methods for Treating HCV," which is incorporated herein by reference in its entirety. Clinical models were evaluated. These treatment regimens included the administration of Compound 1 and Compound 2, but not the administration of interferon or ribavirin. Comparable SVR rates are expected for interferon non-responders.

[0251] figure 1 Shown are the predicted median SVR percentages and 90% predicted median SVR for genotype 1 naïve subjects treated with a 2-DAA regimen consisting of Compound 1 (400 mg once daily) and Compound 2 (120 mg once daily). % SVR confidence interval. Different treatment durations were evaluated. The predicted SVR rate for 12-week treatment was approximately 95%. A...

Embodiment 2

[0259] Example 2: Combination of Compound 1 and Compound 2 in vitro

[0260] Figure 9 It was shown that the combination of Compound 1 and Compound 2 exhibited a significant synergistic effect on HCV inhibition as tested in HCV GT 1bCon-1 replicating cells. Results were generated using the Prichard and Shipman model (Prichard et al. Antiviral Research 14:181-205 (1990)).

[0261] Compound 1 inhibits the replication of HCV stable subgenomic replicons containing the NS3 gene from GT 1a, 1b, 2a, 3a, 4a or 6a, where EC 50 Values ​​range from 0.85 to 2.8 nM. Notably, compound 1 is potent against replicon containing GT3a protease, in which EC 50 The value is 1.6 nM. Compound 1 retained its activity against common GT1a and 1b variants at NS3 amino acid positions 155 and 168 that confer resistance against other HCV protease inhibitors (Pis). Resistant colony selection studies in GT1a and 1b subgenomic replicon cells identified A156T in GT1a and A156V in GT1b as the most common va...

Embodiment 3

[0271] Example 3: High SVR in HCV Genotype 1 (GT1 ) Non-Cirrhosis-Naive Patients or Pegylated Interferon / Ribavirin Non-Responders Treated with Combination of Compound 1 and Compound 2

[0272] Compounds 1 and 2 were characterized by potent pan-genotype in vitro antiviral activity against major HCV genotypes (GTs), including activity against key known resistance-associated variants and a high barrier to resistance selection. Monotherapy with Compound 1 or Compound 2 resulted in a mean 4 log reduction in HCV plasma viral load from baseline in GT1-infected subjects with and without compensated cirrhosis 10 IU / mL.

[0273] In this Phase 2 study, 12 weeks of treatment with Compound 1 and Compound 2 were evaluated in HCV GT1 -infected subjects without cirrhosis. Treatment naïve (TN) or pegIFN / RBV (pegIFN / RBV) nonresponsive subjects with non-cirrhotic GT1 infection received Compound 1 200 mg + Compound 2 120 or 40 mg once daily for 12 weeks , and followed up for 24 weeks. Efficac...

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Abstract

The present invention features interferon-free therapies for the treatment of HCV. Preferably, the treatment is over a shorter duration of treatment, such as no more than 12 weeks. In one aspect, thetreatment comprises administering at least two direct acting antiviral agents to a subject with HCV infection, wherein the treatment lasts for 12 weeks and does not include administration of either interferon or ribavirin, and said at least two direct acting antiviral agents comprise (a) Compound 1 or a pharmaceutically acceptable salt thereof and (b) Compound 2 or a pharmaceutically acceptable salt thereof.

Description

technical field [0001] The present invention relates to an interferon-free and ribavirin-free treatment for hepatitis C virus (HCV). Background technique [0002] HCV is an RNA virus belonging to the Hepacivirus genus in the Flaviviridae family. The enveloped HCV virion contains a positive-sense RNA genome that encodes all known virus-specific proteins in a single uninterrupted open reading frame. The open reading frame comprises about 9500 nucleotides and encodes a single large polyprotein of about 3000 amino acids. The polyprotein comprises core protein, envelope proteins E1 and E2, membrane-bound protein p7, and nonstructural proteins NS2, NS3, NS4A, NS4B, NS5A and NS5B. [0003] Chronic HCV infection is associated with progressive liver pathology including cirrhosis and hepatocellular carcinoma. Chronic hepatitis C can be treated with a combination of pegylated interferon-alpha and ribavirin. There are substantial limitations in efficacy and tolerability, as many use...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/06A61K31/454A61K31/7072A61P31/14
CPCA61K31/454A61K31/7072A61K38/06A61K2300/00A61K31/497A61P1/16A61P31/12A61P31/14A61P31/22A61P43/00
Inventor W.M.奥尼B.M.伯恩斯坦A.L.坎贝尔S.杜塔林志威刘巍R.M.梅农S.门兴T.J.波萨德基王恬力
Owner ABBVIE INC
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