Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study.

ABSTRACT:

Background

Vaniprevir (MK-7009) is a hepatitis C virus (HCV) non-structural 3/4a protease inhibitor which significantly increases virologic response rates in HCV genotype (GT) 1-infected patients when added to peginterferon and ribavirin (PR).

Methods

This was a phase II, multicenter, double-blind, randomized, dose-ranging study in Japanese patients with HCV GT1 infection and previous relapse. Patients received twice daily vaniprevir 100, 300, or 600 mg, or placebo plus PR for 4 weeks then PR alone for 2 weeks. Further treatment with PR was continued up to a maximum of 72 weeks. The primary endpoint was rapid virologic response (RVR; undetectable HCV RNA at treatment week 4).

Results

Ninety patients completed 4 weeks of vaniprevir/placebo plus PR. Rates of RVR were si

SUBMITTER: Hayashi N 

PROVIDER: S-EPMC4318982 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature