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VPHM Message Board

  • nuhawkus nuhawkus Nov 28, 2005 12:52 PM Flag

    796 phase 1b additional results

    From the VPHM website. These may have ben mentioned in the conference but I don't recall hearing them all. Sounds very promising to me.

    Status

    In November 2005, ViroPharma announced preliminary results from their Phase 1b proof of concept study with HCV-796. In this trial, HCV-796 demonstrated antiviral effects in adult patients with chronic hepatitis C infection. The patient cohort with the highest exposure to HCV-796 achieved a peak mean HCV viral load reduction of 1.4 log10, or 96 percent, on day four of a 14 day dosing period. HCV-796 was found to be generally well tolerated, with favorable pharmacokinetics and no dose-limiting toxicities.

    In this cohort, the mean reduction in HCV RNA was 1.4 log10 (96 percent) on day four, 1.3 log10 (95 percent) on day seven, and 0.7 log10 (80 percent) at day 14. At day four, 83 percent of patients in this cohort had reductions from baseline greater than 1.0 log10 on day four; 33 percent of these subjects had reductions greater than 1.5 log10; 25 percent of these subjects had reductions greater than 2.0 log10. On day 14, 17 percent of subjects in this group had reductions from baseline greater than 2.0 log10.

    HCV-796 was generally well tolerated across the treatment groups, and no dose-limiting toxicity was identified. Mild to moderate headache was the most frequent adverse event reported overall. There were no treatment-emergent serious adverse events. HCV-796 exhibited favorable pharmacokinetics with an estimated mean elimination half-life of 42-54 hours across dose groups. HCV-796 drug levels increased less than proportionally

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