Further EU approval for S-P's HCV drug combo

US drug major Schering-Plough says that the European Commission has approved 48-week standard-dose Pegintron (peginterferon alfa-2b, 1.5mcg/kg once-weekly) and Rebetol (ribavirin, 800mg-1,400mg, daily) combination therapy for re-treating adult patients with chronic hepatitis C whose prior treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy did not result in a sustained response. According to the firm, this regimen is the first and only pegylated interferon combination therapy approved in the European Union for re-treating both hepatitis C relapsers and non-responders.

The approval is based on results from an ongoing non-comparative clinical study in which 1,336 patients with moderate-to-severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were re-treated with Pegintron combination therapy. In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response, with 57% of patients who had undetectable virus (HCV-RNA) at week 12 going on to achieve SVR with a 48-week course of therapy. Within this subgroup, the SVR rates were 59% and 47% for patients who failed prior therapy with non-pegylated or pegylated interferon, respectively.