Viropharm, Wyeth Announce Potential Safety Issue in Phase II HCV-796 Trial

ViroPharma and Wyeth announced that they will discontinue dosing with HCV-796 in combination with pegylated interferon and ribavirin in their Phase II Hepatitis C study.

All subjects will have the option of continuing on the combination therapy of pegylated interferon and ribavirin, the standard of care, ViroPharma and Wyeth said.

According to the companies, this decision follows a review by the joint safety review board of data accumulated to date, which show elevated liver enzyme levels in some patients after eight weeks or more of therapy with HCV-796 with pegylated interferon and ribavirin.

The companies said they conducted a thorough safety review of liver enzyme levels in all patients. Clinically significant elevations of liver enzymes were observed in approximately 8 percent of patients receiving HCV-796, including two patients who experienced serious adverse events leading to withdrawal from active therapy, the companies added.