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First Phase III HCV data for sofosbuvir

November 28, 2012 1:56 AM UTC

Gilead Sciences Inc. (NASDAQ:GILD) said once-daily 400 mg sofosbuvir plus ribavirin for 12 weeks met the primary endpoint of a greater proportion of patients achieving a sustained virologic response (SVR) 12 weeks after the end of treatment vs. placebo plus ribavirin in the Phase III POSITRON trial to treat HCV genotype 2 or 3 infection (78% vs. 0%, p-value undisclosed). SVR12 rates for sofosbuvir plus ribavirin were 93% in patients with HCV genotype 2 infection and 61% in patients with HCV genotype 3 infection. The double-blind, international trial enrolled 278 patients with chronic HCV genotype 2 or 3 infection who were intolerant, ineligible or unwilling to receive interferon.

Analysts said the data, the first Phase III data for sofosbuvir, were in line with expectations. The populations for HCV genotype 2 or 3 infections are smaller than for HCV genotype 1 infection. Based on 2011 estimates, Gilead said genotype 1 represents about 73% of HCV infections in the U.S. and about 63% of HCV infections in Europe. ...