Bristol-Myers Squibb announced that the FDA has granted its DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).

Asunaprevir (ASV) is an investigational NS3 protease inhibitor, which has been studied as a component of DCV-based treatment regimens. Daclatasvir (DCV) is an investigational NS5A replication complex inhibitor that has been studied as a foundational agent for multiple direct-acting antiviral (DAA) based combination therapies.

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The designation is based on data from an ongoing Phase 3 clinical trial program evaluating the all-oral combination regimen of daclatasvir and asunaprevir without ribavirin.

Previously the FDA granted Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/ asunaprevir/BMS-791325) Breakthrough Therapy Designation, which expedited the start of the ongoing Phase 3 UNITY Program. Study populations include non-cirrhotic treatment naïve and experienced patients, as well as cirrhotic treatment naïve and experienced patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

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