Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) of daclatasvir in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3.
The initial NDA now includes data from the ALLY-3 trial (n=152), a Phase 3 open-label study in which patients received daclatasvir 60mg + sofosbuvir 400mg once daily for 12 weeks with 24 weeks of follow-up. The study demonstrated high cure rates for the combination therapy with sustained virologic response 12 weeks after treatment (SVR12) seen in 90% of treatment-naive genotype 3 HCV patients, and in 86% of treatment-experienced patients. SVR12 rates were seen in 96% of non-cirrhotic genotype 3 patients, regardless of treatment history.
Daclatasvir is an investigational NS5A replication complex inhibitor. Sofosbuvir is an HCV NS5B polymerase inhibitor indicated as part of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection.
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