Daclatasvir: Additional Phase IIa data

According to analysts attending the American Association for the Study of Liver Diseases meeting in Boston, an investigator presented data from the open-label Phase IIa AI-444040 trial in 170 non-cirrhotic treatment-naïve patients with HCV genotype 1, 2 or 3 infection showing that 12-week treatment with sofosbuvir plus daclatasvir without ribavirin led to an SVR4 rate of 98%. Partner Gilead Sciences Inc. (NASDAQ:GILD, Foster City, Calif.) deferred to Bristol-Myers on the data, while BMS could not be reached for details. In an abstract for the trial, the companies also reported that 24-week regimens of sofosbuvir plus daclatasvir without ribavirin for 24 weeks led to an SVR12 in 100% of patients with HCV genotype 1 infection and 88-100% of patients with HCV genotype 2/3 infection. The partners reported interim data from 88 patients in April (see BioCentury, April 23).

In 2011, Bristol-Myers partnered with Pharmasset Inc., now part of Gilead, to evaluate the combination of sofosbuvir plus daclatasvir for HCV infection. Late last year, the partners expanded the trial to add 120 patients across 4 new 12-week arms that will evaluate sofosbuvir plus daclatasvir with and without ribavirin in treatment-naïve patients with HCV genotype 1 infection; and sofosbuvir plus daclatasvir with and without ribavirin in patients with HCV genotype 1 who have previously failed treatment with Incivek telaprevir or Victrelis boceprevir (see BioCentury, Jan. 24, 2011 & Nov. 7, 2011). ...