Gilead reports more Phase III HCV data

Gilead Sciences Inc. (NASDAQ:GILD) reported top-line data on Monday from a pair of Phase III trials evaluating sofosbuvir ( GS-7977) in treatment-naïve HCV patients. In the FISSION trial in patients with chronic HCV genotype 2 and 3 infection, once-daily sofosbuvir plus ribavirin for 12 weeks met the primary endpoint of non-inferiority to interferon plus ribavirin for 24 weeks in the proportion of patients achieving a sustained virologic response (SVR) 12 weeks after the end of treatment. Sofosbuvir plus ribavirin led to SVR12 rates of 97% in patients with genotype 2 infection and 56% in patients with genotype 3 infection, while interferon plus ribavirin led to SVR12 rates of 78% in patients with genotype 2 and 63% in patients with genotype 3.

In the NEUTRINO trial in patients with chronic HCV genotype 1, 4, 5 and 6 infection, sofosbuvir plus ribavirin and interferon for 12 weeks met the primary endpoint of improving the SVR12 rate vs. a predefined historical control SVR12 rate (90% vs. 60%, p<0.001). SVR12 rates were 89% in patients with genotype 1 infection and 97% in patients with genotype 4, 5 or 6 infection. ...