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Methods of treating HIV with cabotegravir and rilpivirine

A technology of rilpivirine and HIV-1, applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc.

Pending Publication Date: 2022-05-13
VIIV HEALTHCARE CO +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these 2DRs include ritonavir-enhanced PIs, which are associated with multiple metabolic syndrome and cardiovascular-related diseases, and may nullify any expected benefit in reducing drug exposure and cumulative toxicity

Method used

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  • Methods of treating HIV with cabotegravir and rilpivirine
  • Methods of treating HIV with cabotegravir and rilpivirine
  • Methods of treating HIV with cabotegravir and rilpivirine

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Experimental program
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Effect test

Embodiment 1

[0270] ATLAS (NCT02951052) and FLAIR (NCT02938520) are two randomized, open-label, international phase 3 studies demonstrating that switching to monthly intramuscular (IM) injections of CAB LA+RPV LA is comparable to current antiretroviral regimens (CARs) than non-inferiority. The injectable CAB+RPV LA regimen requires monthly injection visits within a prespecified time window, representing a paradigm shift for patients from daily oral dosing.

[0271] The injection is scheduled for Q4 weeks, and the planned dosing date has a dosing window of ±7 days. Adherence to LA therapy was calculated as the number of on-time injection visits that occurred within the dosing window divided by the number of expected dosing visits during the 48-week period. Both trial protocols allow for oral bridging (using oral dosing to make up for planned missed injections) to allow dosing flexibility for planned clinical point absences (such as vacation or travel) while allowing subjects to maintain LA...

Embodiment 2

[0281] A two-compartment model with first-order oral and intramuscular (IM) absorption and first-order elimination adequately described data from 23,926 concentration records in 1647 subjects following oral and LA administration (Han K, Patel P, Baker M et al Human, Populationpharmacokinetics of Cabotavir in adult healthy subjects and HIV-1 infected patients following administration of oral tablet and long acting intramuscular injection. Abstract WEPDB0205.22nd International AIDS Conference23–27July 2018, Amsterdam, the Netherlands).

[0282] Covariates retained in the model included gender, BMI, needle length, and fractional injection of the absorption rate constant (KA LA) after LA administration, as well as the effect of current smoker status and body weight on CL and volume. No CAB dose adjustment was required for the covariate assessed.

[0283] In the Phase 3 study, the 5th percentile of Individual Predicted Concentration (IPRED) at the postloading trough (0.65 μg / mL) fr...

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Abstract

The present invention relates to a method of treating HIV in a human in need thereof, the method comprising administering to the human a therapeutically effective amount of a combination of Cabotegravir, or a pharmaceutically acceptable salt thereof, and rilpivirine, or a pharmaceutically acceptable salt thereof.

Description

[0001] field of invention [0002] The present invention relates to a method of treating human HIV by in vivo administration of Cabotegravir or a pharmaceutically acceptable salt thereof in combination with rilpivirine or a pharmaceutically acceptable salt thereof. Background technique [0003] The contemporary standard of care for first-line treatment of HIV-1 infection in antiretroviral therapy (ART)-naive adults is a regimen of ≥3 antiretroviral drugs, including two nucleoside reverse transcriptase inhibitors (NRTI) and one other drug from the classes of enhanced protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), or non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, there are concerns about the need for lifelong treatment with drugs with varying safety and tolerability profiles. Therefore, a 2-drug regimen (2DR) capable of inducing and / or maintaining virological suppression while reducing lifetime cumulative drug exposure and potentia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4985A61K31/505A61K9/00A61K9/20A61P31/18
CPCA61K31/4985A61K31/505A61K9/0019A61K9/20A61P31/18A61K2300/00A61K47/26A61K9/2054A61K47/34A61K9/0053
Inventor H.M.L.格劳韦尔斯S.L.福德D.A.马戈利斯S.L.F.罗塞努W.R.斯普林R.M.范索林根-里斯泰亚P.E.O.威廉姆斯
Owner VIIV HEALTHCARE CO
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