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Enanta Pharmaceuticals Inc announces results from four all-Oral, Interferon-Free, phase 3 Studies for treatment of Genotype 1 Hepatitis C Virus Infection


Friday, 31 Jan 2014 07:44am EST 

Enanta Pharmaceuticals Inc:Says results from the PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II studies.Says these studies are the remaining four phase 3 studies of the six phase 3 registrational studies being conducted by AbbVie for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection using a regimen containing Enanta's lead protease inhibitor ABT-450.Says ABT-450 is part of AbbVie's investigational three direct-acting antiviral regimen consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333.Says these studies were conducted with and without ribavirin.Says the combination of the three different mechanisms of action in this regimen interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.Says Results from these studies demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients and low rates of discontinuation due to adverse events.Says Overall, across the four studies, the three direct-acting antiviral regimen was well tolerated with few adverse event-related discontinuations.Says the most commonly reported adverse events in PEARL-II and PEARL-III were fatigue and headache. In PEARL-IV and TURQUOISE-II, the most commonly reported adverse events were fatigue, headache and nausea.