Sofosbuvir: Phase III ongoing

Gilead said a DSMB recommended continuation of the open-label Phase III ION-1 trial of a once-daily, oral fixed-dose combination of 400 mg sofosbuvir plus 90 mg ledipasvir based on a review of safety data from the first 200 patients in all 4 treatment arms and SVR4 data from 100 patients in the 12-week treatment arms. ION-1 trial is evaluating the fixed-dose combination with or without ribavirin for 12 or 24 weeks in about 800 patients. Gilead said the recommendation is based upon SVR4 rates exceeding the predefined threshold of 60% and the absence of significant safety issues. Gilead is also evaluating the fixed-dose combination of sofosbuvir plus GS-5885 with or without ribavirin in the Phase II LONESTAR trial in treatment-naïve and treatment-experienced patients and the Phase III ION-2 trial in 400 treatment-experienced patients with HCV genotype 1 infection. ...