Bristol-Myers Squibb announced late-breaking data from ALLY Trial evaluating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C virus (HCV) patients.
This Phase 3 open-label clinical trial enrolled 152 genotype 3 HCV patients (101 treatment-naïve patients and 51 treatment-experienced patients) in two cohorts each receiving daclatasvir 60mg and sofosbuvir 400mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA
The results of the study showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced patients. Data from an open-label, randomized study of daclatasvir with sofosbuvir in genotypes 1, 2, and 3 demonstrated that the 24-week regimen of daclatasvir and sofosbuvir (with or without ribavirin) achieved SVR12 in 89% of patients with genotype 3.
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