Study of Sovaldi for retreatment of patients with Hep C shows benefits-Gilead

Gilead Sciences has announced results from an open-label clinical trial (Study GS-US-334-0109) evaluating once-daily Sovaldi (sofosbuvir) 400 mg tablets for the retreatment of chronic Hepatitis C virus (HCV) infection among patients who failed prior therapy. Patients with genotype 1 HCV infection (n=80) received 12 weeks of treatment with once-daily Sovaldi plus weight-based ribavirin (RBV) twice-daily and pegylated interferon. Patients in the study had failed prior regimens containing peg-IFN, RBV and an investigational NS3 protease inhibitor, with or without investigational direct-acting antivirals (DAAs)(NS5A and/or non-nucleoside NS5B inhibitors).

Forty-five percent of patients had received more than one course of prior therapy, and 90 percent had at least one viral mutation associated with HCV NS3, NS5A or NS5B drug resistance. Among the 50 patients for whom sustained virologic response data was available 12 weeks after the end of treatment (SVR12), 74 percent achieved SVR12. Additionally, 80 percent of patients with baseline resistance against two or more DAAs achieved SVR12.

In addition, retreatment with Sovaldi in genotype 2 (n=11) or genotype 3 (n=96) HCV infected patients who previously failed treatment with 12 or 16 weeks of Sovaldi plus RBV in the Phase III studies FISSION, FUSION and POSITRON was evaluated. Thirty-six percent of these patients had cirrhosis. Patients were retreated either with a 12-week regimen of Sovaldi, RBV and peg-IFN, or a 24-week, interferon-free regimen of Sovaldi plus RBV. Among patients with available SVR12 data, 63 percent of those who received the 24-week all-oral regimen and 92 percent of those who received the 12-week regimen of Sovaldi, RBV, and peg-IFN achieved SVR12. These data will be presented at the 49th Annual Meeting of the European Association for the Study of the Liver.