Bristol-Myers Squibb Co. Announces Interim Results From Phase II Open-Label Study

Bristol-Myers Squibb Co. announced interim results from a Phase II open-label study of daclatasvir, Bristol-Myers Squibb’s NS5A replication complex inhibitor, and GS-7977, a nucleotide NS5B polymerase inhibitor, in treatment-naïve patients with hepatitis C genotypes one, two and three. In this interim analysis, a combination of the two oral, once-daily investigational compounds taken for 24 weeks, with or without ribavirin, achieved a rapid and sustained viral response. Overall, 100% of patients with genotype one, two, or three HCV achieved viral load below the lower limit of quantification at Week four on treatment. In the genotype 1 HCV treatment groups, 100% of patients achieved sustained virologic response through four weeks off-treatment (SVR4). In the genotypes two and three treatment groups, 91% (40/44) of patients achieved SVR4. The data were presented on April 19, 2012 at the International Liver Congress (ILC), the 47th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain. The most frequent (≥25% overall) adverse events (AE) on treatment, based upon the most recent 12-week interim safety analysis, were fatigue, headache and nausea. Drug-related AEs were generally mild and did not lead to treatment discontinuation.