Methods and compositions for treating hepatitis c virus

The technology of a composition and treatment scheme, applied in the field of compositions for the treatment of hepatitis C virus infection, can solve the problems that the treatment has shortcomings, and the resistance to NS3 protease inhibitors is not desired.

Inactive Publication Date: 2014-12-24
GILEAD PHARMASSET LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Although boceprevir and telaprevir regimens offer alternatives, these alternative treatments still have disadvantages
Furthermore, patients with genotype 1 who failed treatment with boceprevir and / or telaprevir in combination with pegylated interferon and ribavirin may develop undesired resistance to NS3 protease inhibitors (E.g., Pawlotsky, Hepatology (2011) 53 (5):1742-1751.)

Method used

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  • Methods and compositions for treating hepatitis c virus
  • Methods and compositions for treating hepatitis c virus
  • Methods and compositions for treating hepatitis c virus

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0051] A first embodiment relates to a method of treating a patient infected with hepatitis C virus comprising administering to the patient an effective amount of GS-7977 and an effective amount of ribavirin for a period of time.

[0052] In a first aspect of the first embodiment, the period of time is selected from about 2 weeks to about 12 weeks, about 3 weeks to about 12 weeks, about 4 weeks to about 12 weeks, about 5 weeks to about 12 weeks, about 6 weeks to about 12 weeks, From about 7 weeks to about 12 weeks, from about 8 weeks to about 12 weeks, from about 9 weeks to about 12 weeks, from about 10 weeks to about 12 weeks, from about 11 weeks to about 12 weeks, and about 12 weeks. In a subembodiment, the period of time is 12 weeks. In another subembodiment, the period of time is 8 weeks.

[0053] In a second aspect of the first embodiment, the effective amount of GS-7977 is selected from the group consisting of about 100 mg to about 800 mg, about 200 mg to about 800 mg, ...

Embodiment

[0123] Using a standardized automated RNA extraction system with standardized controls and calibrators, the Roche trial, conducted a quantitative HCV RNA test for use in clinical trials. The LOD of the established assay was 15 IU / mL (defined by 95% hit rate using WHO criteria). Serum samples were used to measure HCV RNA levels.

[0124] US 2010 / 0226885 (US12 / 376,180), which is incorporated by reference, also discloses a method of measuring HCV RNA levels using RT-PCR to measure whether a patient has achieved HCV negative status.

[0125] In Vitro Antiviral Synergy of Combination of GS-7977 and Ribavirin

[0126] The antiviral effect of GS-7977 in combination with ribavirin was assessed using the HCV genotype 1a replicon (Robinson et al., Antimicrob. Agents Chemother. (2010) 54(8):3099-3106). Cells were grown in cell culture medium containing Dulbecco's Modified Eagle Medium (DMEM) supplemented with 10% HyClone FBS, 100 units / mL penicillin, 100 μg / mL streptomycin, and 0.1...

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Abstract

Disclosed herein is a method of treating a subject infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period. Also disclosed herein is a composition useful for the treatment of hepatitis C virus infection, said composition comprising an effective amount of GS-7977 and an effective amount of ribavirin.

Description

technical field [0001] Disclosed herein is a method of treating a patient infected with hepatitis C virus comprising administering to the patient an effective amount of GS-7977 and an effective amount of ribavirin for a period of time. In one aspect, the method comprises administering to the patient an interferon-free regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In particular aspects, the method is sufficient to produce undetectable levels of HCV RNA in the patient for at least 12 weeks after the end of the period of time. Also disclosed herein is a composition for treating hepatitis C virus infection, said composition comprising an effective amount of GS-7977 and an effective amount of ribavirin. Background technique [0002] Hepatitis C virus ("HCV") infection is a major health problem resulting in chronic liver disease (e.g., liver cirrhosis and liver cancer) in a significant number of infected individuals, estimated by the Worl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4196A61K31/513A61P31/14
CPCA61K31/685A61K31/7056A61P1/16A61P31/14A61K2300/00
Inventor 米利亚姆·米歇尔·贝里罗伯特·G.·海因兹威廉·T.·西蒙兹亚德里安·S.·雷莫红梅克里斯蒂·M.·赫布纳
Owner GILEAD PHARMASSET LLC
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