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news.A treatment for hepatitis C being developed by ViroPharma and Wyeth Pharmaceuticals has been shown to be well tolerated and effective in a small 14 day phase Ib trial.
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The trial was a placebo-controlled study of the drug candidate, HCV-796, administered orally for 14 days to patients with chronic hepatitis C virus (HCV) infection who were naive to treatment. Patients received 50, 100, 250, 500, 1,000, or 1,500mg oral doses of the drug or placebo given as monotherapy twice daily.
Peak antiviral response was achieved at doses of 500mg twice daily and higher. The 500mg, 1,000mg, and 1,500mg dose groups achieved peak mean HCV viral load reductions of 96% to 97% on day four of a 14-day dosing period.
The safety profile of this study indicates that oral doses of HCV-796 are generally well tolerated with no serious treatment-emergent adverse affects when given for 14 days. Mild to moderate headache was the most frequently reported adverse event.
“Overall, the findings of this study show that monotherapy with HCV-796 is well tolerated with no dose limiting toxicities, and that it displays clear antiviral activity across multiple HCV genotypes,” said Steve Villano, ViroPharma's vice president of clinical research and development.