The preliminary data were produced from a dose range of 100mg BID to 1,000mg BID of HCV-796 dosed over a 14-day period in combination with pegylated interferon alfa-2b.
These combination data demonstrate antiviral effects of HCV-796 across multiple genotypes of hepatitis C virus, in treatment-naive adult subjects with chronic hepatitis C infection.
Across all dose groups, the combination of HCV-796 and pegylated interferon produced a mean viral reduction of between 3.3 and 3.5 log10 (99.95% to 99.97%) after 14 days of treatment compared to 1.7 log10 with pegylated interferon alone.
During the treatment period, there was no evidence of viral rebound with the combination therapy relative to pegylated interferon alone. No dose-limiting toxicities were seen and although safety data remain blinded, tolerability was consistent with that expected from pegylated interferon.
“These data are clearly very promising as HCV-796 in combination with pegylated interferon appears highly potent with substantial antiviral activity across all doses tested,” commented Colin Broom, ViroPharma’s chief scientific officer. “To date we have not identified any dose-limiting toxicities with HCV-796 and plan to initiate phase II with the 500mg BID dose, to be followed by further evaluation of the dose response.”