Enanta announced that the FDA has granted Breakthrough Therapy designation for AbbVie‘s investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin for the treatment of genotype 1 (GT1) hepatits C virus (HCV) infection. Enanta’s HCV protease inhibitor ABT-450/r is one of the three DAAs included in this regimen.
AbbVie is currently studying all-oral, triple-DAA combination regimens in Phase 3 trials. The Phase 3 program consists of more than 2,000 patients with genotype 1 HCV infection. The DAAs in the trials include ABT-450/r (protease inhibitor and ritonavir) combined with two of AbbVie’s investigational DAAs, ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor), and are being dosed with and without ribavirin.