US pharma major Bristol-Myers Squibb (NYSE: BMY) says that primary endpoints were successfully met in ALLY-1, a Phase III clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir (Gilead Sciences’ blockbuster hepatitis C drug Sovaldi) once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV.
The data were presented as a late-breaker at The International Liver Congress 2015, the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, from April 22-26.
The study’s primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. Among all ALLY-1 patients, 94% of those with post-transplant HCV recurrence and 83% of all participants with advanced cirrhosis achieved cure (sustained virologic response 12 weeks after treatment; SVR12).
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