Bristol-Myers Squibb announced results from the ALLY-1 Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) infection with either advanced cirrhosis or post-liver transplant recurrence of HCV.
ALLY-1, an open-label clinical trial enrolled treatment-naïve and treatment-experienced patients with HCV infection of any genotype in two cohorts: advanced cirrhosis (n=60) and post-liver transplant with HCV recurrence (n=53). All patients received daclatasvir plus sofosbuvir with ribavirin for 12 weeks. The primary endpoint was the sustained virologic response (SVR12) rate (defined as HCV RNA
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 ALLY-1 patients, 94% of those with post-transplant HCV recurrence and 83% of all participants with advanced cirrhosis achieved cure.
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