Gilead's sofosbuvir meets in fourth HCV trial

Gilead Sciences Inc. (NASDAQ:GILD) said once-daily sofosbuvir plus ribavirin given for 12 or 16 weeks each met the primary endpoint in the Phase III FUSION trial to treat chronic HCV genotype 2 and 3 infection in treatment-experienced patients who failed prior interferon-based therapy. Sofosbuvir significantly improved the proportion of patients who achieved a sustained virologic response (SVR) 12 weeks after the end of treatment vs. a predefined historic control SVR12 rate (50% and 73%, respectively, vs. 25%, p<0.001 for both). Overall, 63% of patients had HCV genotype 3 infection. In the 12-week arm, SVR12 rates were 86% in patients with HCV genotype 2 infection and 30% in patients with HCV genotype 3 infection. In the 16-week arm, SVR12 rates were 94% in patients with HCV genotype 2 infection and 62% in patients with HCV genotype 3 infection.

FUSION, which enrolled 201 patients, is the fourth and final trial in the Phase III program of sofosbuvir for HCV infection. Gilead previously reported that sofosbuvir met the primary SVR12 endpoint in each of the Phase III POSITRON, FISSION and NEUTRINO trials (see BioCentury Extra, Feb. 4). ...