TMC435: Phase II start
Medivir said an open-label Phase II trial will begin this month to evaluate daily oral 150 mg TMC435 in combination with daily oral 30 mg daclatasvir ( BMS-790052) from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) for 12 or 24 weeks in about 180 patients who are treatment-naive or are null responders. Patients with HCV genotype 1a infection will receive the combination plus ribavirin, while patients with HCV genotype 1b infection will receive the combination with or without ribavirin. Medivir said patients with advanced liver disease will constitute about 35% of the total treated population. In December, Johnson & Johnson and Bristol-Myers partnered to evaluate combinations of the pharma's HCV candidates (see BioCentury, Dec. 5, 2011 & April 23, 2012). ...