EU approves Solvadi for Hepatitis C-Gilead Sciences

The European Commission has granted marketing authorization for Sovaldi (sofosbuvir) 400 mg tablets, from Gilead Sciences, for the treatment of chronic Hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)).

Approval is supported primarily by data from four Phase III studies, NEUTRINO, FISSION, POSITRON and FUSION in which 12 or 16 weeks of Sovaldi-based therapy was found to be superior or non-inferior compared with the currently available treatment options RBV/peg-IFN or historical controls, based on sustained virologic response (where HCV becomes undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent.

Data from two additional Phase III studies, VALENCE and PHOTON-1 were added to the marketing authorization application. In all Phase III studies, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.