SVR12 With Combo Hepatitis C Therapy for Cirrhosis Patients in Study

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

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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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