FDA committee recommends approval of GS 7977 (Gilead)/ribavirin for Hep C

The FDA's Antiviral Drugs Advisory Committee has voted unanimously that the available data support approval of the once-daily GS 7977 (sofosbuvir), from Gilead Sciences, in combination with ribavirin for the treatment of chronic Hepatitis C in adult patients with genotype 2 and 3 infection. This follows a vote supporting approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic Hepatitis C in treatment-na�ve adult patients with genotype 1 and 4 infection.

The sofosbuvir NDA is supported primarily by data from four Phase III studies NEUTRINO FISSION POSITRON and FUSION in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls based on the proportion of patients who had a sustained virologic response 12 weeks after completing therapy (SVR12). Data from an additional Phase III study VALENCE were filed to the NDA. In this study patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks.