ViroPharma Announces Data From HCV-086 Proof-of-Concept Study

ViroPharma has announced results from the Phase Ib proof-of-concept study with HCV-086, an orally dosed hepatitis C (HCV) inhibitor, being co-developed with Wyeth.

This randomized, double-blind, placebo-controlled, sequential-group study of ascending multiple doses was designed to assess the safety, tolerability and antiviral effect of HCV-086 on HCV RNA concentrations in subjects with chronic HCV infection.

In each of five different dose groups, subjects with a variety of HCV genotypes were assigned to receive HCV-086 or placebo for 14 days. The results of the study indicated that after 14 days of treatment the greatest mean change in plasma HCV RNA concentrations occurred in the highest dose group.

The joint steering committee of the ViroPharma-Wyeth collaboration decided that, overall, the antiviral activity of HCV-086 does not support further development of HCV-086. HCV-086 demonstrated favorable pharmacokinetics and was generally safe and well-tolerated, although in the highest dose group gastrointestinal adverse events occurred in several subjects and caused discontinuation of treatment in two subjects.