ViroPharma Incorporated has announced additional data from a phase 1b study of HCV- 796, a unique, orally dosed hepatitis C virus (HCV) polymerase inhibitor at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).
This meeting is being held in Barcelona, Spain. These data on the antiviral activity and tolerability of twice daily HCV-796 in combination with pegylated interferon alfa-2b (peg-IFN) elaborate on previously presented data. HCV-796 is currently undergoing phase 2 evaluations and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth.
These phase 1b combination data demonstrate the additive antiviral effects of HCV-796 across multiple genotypes of hepatitis C virus, in treatment-naïve adult subjects with chronic hepatitis C infection. HCV-796 dosed twice daily plus peg-IFN displays clinical antiviral activity that is greater than that of HCV-796 or peg-IFN alone across all dose cohorts and tested HCV genotypes. Final safety and tolerability data show that HCV-796 is generally well tolerated when added to peg-IFN. Adverse events were generally consistent with known effects of interferons. No dose-limiting toxicities were observed across the range of HCV-796 study doses.
"In this phase 1b study, HCV-796 provided added antiviral activity to that of pegylated interferon across multiple HCV genotypes and did so largely without altering interferon's tolerability profile," commented Colin Broom, ViroPharma's chief scientific officer. "The adverse events observed in patients on combination therapy were typical of those seen in patients on pegylated interferon alone. The antiviral activity of HCV-796, its strong tolerability profile, and its lack of dose limiting toxicities encourage us as we proceed expeditiously through our ongoing phase 2 programme."