Sovaldi sofosbuvir: Additional Phase II data

Additional data from the open-label, U.S. Phase II Study GS-US-342-102 trial in 154 treatment-naïve patients with HCV genotypes 1-6 infection without cirrhosis showed that once-daily 400 mg Sovaldi plus once-daily 25 or 100 mg GS-5816 for 12 weeks led to an SVR 12 weeks after the end of treatment in 94.8% of patients in the low-dose GS-5816 arm and in 96.1% of patients in the high-dose GS-5816 arm. Specifically, SVR12 rates were 96% for the low-dose GS-5816 arm and 100% for the high-dose GS-5816 arm in patients with HCV genotype 1 infection; 91% for the low-dose GS-5816 arm and 100% for the high-dose GS-5816 arm in patients with HCV genotype 2 infection; 93% for both GS-5816 arms in patients with HCV genotype 3 infection; 100% for the low-dose GS-5816 arm and 86% for the high-dose GS-5816 arm in patients with HCV genotype 4 infection; 100% for the low-dose GS-5816 arm in patients with HCV genotype 5 infection (no patients with HCV genotype 5 infection received high-dose GS-5816); and 100% for both GS-5816 arms in patients with HCV genotype 6 infection. Virologic failure occurred in 3 patients in the low-dose GS-5816 arm and 1 patient in the high-dose GS-5816 arm. There was 1 death in the low-dose GS-5816 arm. Data were presented at the European Association for the Study of the Liver meeting in London. In March, Gilead reported SVR4 data from the trial (see BioCentury, March 31). Next half, Gilead plans to start Phase III testing with the combination. ...