Asunaprevir/daclatasvir/BMS-791325: Phase III data

The double-blind, placebo-controlled, international Phase III UNITY-2 trial in 202 patients with chronic HCV genotype 1 infection and compensated cirrhosis showed that a fixed-dose oral combination of 200 mg asunaprevir, 30 mg daclatasvir and 75 mg BMS-791325 twice daily for 12 weeks led to an SVR 12 weeks after end of treatment in 93% of treatment-naive patients (n=57) and in 87% of treatment-experienced patients (n=45). When combined with ribavirin, the combination led to an SVR12 rate of 98% in treatment-naive patients (n=55) and of 93% in treatment-experienced patients (n=45). In treatment-naive patients, 4 patients receiving the combination without ribavirin relapsed post-treatment. In treatment-experienced patients receiving the combination without ribavirin, 1 patient experienced on-treatment failure and 5 patients relapsed post-treatment. In treatment-experienced patients receiving the combination with ribavirin, 2 patients experienced on-treatment failure and 1 patient relapsed post-treatment. Data will be presented at the American Association for the Study of Liver Diseases meeting in Boston in November. ...