Gilead announces new sustained viral response data for Sofosbuvir based regimens in genotype 3-infected Hepatitis C patients

Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from two studies, the Phase 3 VALENCE study and the Phase 2 LONESTAR-2 study, evaluating the oncedaily nucleotide analogue inhibitor sofosbuvir as part of combination therapy for the treatment of chronic hepatitis C virus (HCV) infection among patients infected with genotype 3 HCV. These data will be presented this week at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) taking place in Washington, D.C.

In the Phase 3 VALENCE study, 85 percent (n=212/250) of treatment-naive or treatment-experienced patients with genotype 3 HCV who received a 24-week regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after treatment (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.

“The VALENCE results demonstrate the high efficacy of a 24-week, sofosbuvir-based, interferon-free treatment regimen for genotype 3 HCV patients with and without cirrhosis,” said Stefan Zeuzem, MD, Professor of Medicine and Chief of the Department of Medicine I, J.W. Goethe University Hospital, Frankfurt, Germany, and principal investigator for the VALENCE study. “Notably, the majority of these patients had failed prior therapy, and sofosbuvir was able to produce a sustained virologic response.”

Additionally, the Phase 2 LONESTAR-2 study evaluated 12 weeks of sofosbuvir, RBV and pegylated interferon (peg-IFN) among patients who had previously failed treatment with peg-IFN/RBV, approximately half of whom had cirrhosis. In this study, 83 percent (n=20/24) of genotype 3 patients achieved SVR12.

There were few discontinuations due to adverse events in VALENCE and LONESTAR-2. Sofosbuvir was well tolerated in VALENCE and adverse events in LONESTAR-2 were consistent with the safety profile of peg-IFN/RBV.