Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796

EXTON, Pa., Aug. 10 /PRNewswire-FirstCall/ -- ViroPharma Incorporated announced today the decision made with Wyeth Pharmaceuticals, a division of Wyeth , to discontinue dosing with HCV-796 in combination with pegylated interferon and ribavirin in its current Phase 2 study. All subjects, following consultation with the principal investigators at each site, will have the option of continuing on the combination therapy of pegylated interferon and ribavirin, the standard of care. This decision follows yesterday's review by the joint safety review board of safety data accumulated to date, which show elevated liver enzyme levels in some patients after 8 weeks or more of therapy with HCV-796 with pegylated interferon and ribavirin."This is a clear disappointment in light of the exciting antiviral activity observed to date in this study. Although this represents a potential setback for hepatitis C patients, we are committed to the health and safety of patients, and this decision was absolutely the right thing to do," commented Michel de Rosen, ViroPharma's president and chief executive officer. "We are committed to understanding the observations that led to this decision in the hope of advancing this potential therapeutic agent in the future."
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