Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Daklinza (daclatasvir) in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 3 infection. 

Daklinza is an NS5A replication complex inhibitor that works via dual modes of anti-viral activity inhibiting both RNA replication and virion assembly. In in vitro studies, Daklinza has shown antiviral activity across genotypes 1–6, with EC50 values from picomolar (pM) to low nanomolar (nM) against wild type replicons.

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The FDA approval was based on results from the Phase 3 open-label ALLY-3 clinical trial that evaluated 152 patients with chronic HCV genotype 3 infection and compensated liver disease (n=152). The co-primary endpoints were sustained virologic response rates 12 weeks after completing therapy (SVR12) in each treatment arm. Daklinza plus sofosbuvir resulted in 90% SVR12 in treatment-naive and 86% in treatment-experienced chronic HCV genotype 3 patients. In general, SVR12 rates were higher in genotype 3 patients without cirrhosis regardless of treatment history. 

Daklinza tablets will be available in 30mg and 60mg strengths in 28-count bottles.

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