Sofosbuvir: Phase II started

Gilead began the open-label, U.S. Phase II LONESTAR trial in 100 patients to evaluate a once-daily, oral fixed-dose combination of 400 mg sofosbuvir plus 90 mg GS-5885. Treatment-naïve patients will receive the fixed-dose combination for 8 weeks with and without ribavirin and for 12 weeks without ribavirin, while treatment-experienced patients will receive the fixed-dose combination for 12 weeks with or without ribavirin. The Phase III ION-1 trial is evaluating the fixed-dose combination with or without ribavirin for 12 or 24 weeks in about 800 treatment-naïve patients with HCV genotype 1 infection. The Phase III ION-2 trial, which is slated to begin this month, will evaluate the fixed-dose combination with ribavirin for 12 weeks and with and without ribavirin for 24 weeks in 400 treatment-experienced patients with HCV genotype 1 infection. The company plans to submit regulatory application for the fixed-dose combination in mid-2014. ...