Sofosbuvir: Phase III data
Top-line data from the double-blind, international Phase III FUSION trial in 201 treatment-experienced patients with chronic HCV genotype 2 or 3 infection who failed prior interferon-based therapy showed that once-daily 400 mg sofosbuvir plus ribavirin given for 12 or 16 weeks each met the primary endpoint of improving SVR12 rate 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. Of the 34% of patients who had compensated cirrhosis at baseline, 31% achieved SVR12 in the 12-week arm and 66% achieved SVR12 in the 16-week arm. All patients became HCV RNA negative on treatment and relapse accounted for the virologic failures. No patients discontinued sofosbuvir or ribavirin due to adverse events. The most common adverse events were fatigue, headache, insomnia and nausea. ...