VIROPHARMA, WYETH INITIATE STUDY OF HCV TREATMENT

ViroPharma announced that patient dosing has begun in a Phase II study of HCV-796, a unique orally dosed hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV). The study is being conducted with Wyeth Pharmaceuticals, ViroPharma's partner in development of HCV-796.

The objectives of this trial are to assess the safety, tolerability, pharmacokinetic profile and antiviral activity of HCV-796, when used in combination with pegylated interferon alfa-2b plus ribavirin compared to the current standard of care in treatment-naive subjects with HCV genotype 1 infection and in patients with HCV genotype 1 infection who were non-responders to prior HCV therapy. The companies will add an additional dose or doses of HCV-796 to the trial to further elucidate the dose response.

The study is a randomized, open-label trial. Participation in all dose cohorts will include up to 48 weeks of treatment with combination therapy including HCV-796, and a 24-week follow-up period. Initially, approximately 267 patients will be enrolled to target a minimum of 222 patients into three dosing groups: 74 treatment-naive patients receiving pegylated interferon and ribavirin (control therapy); 74 treatment-naive patients receiving pegylated interferon, ribavirin and 500 mg of HCV-796 every 12 hours; and 74 non-responders receiving pegylated interferon, ribavirin and 500 mg of HCV-796 every 12 hours. After 12 weeks of dosing the 500-mg cohorts, tolerability and antiviral data will be reviewed to identify the additional dose group(s) to further elucidate dose response. The subsequent dose cohort(s) will be enrolled in the same manner as the initial 500-mg cohort.