Enanta announced results from AbbVie’s pivotal Phase 3 TURQUOISE-II study of the investigational three direct-acting (3D) antiviral regimen for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis. The investigational regimen consists of a fixed-dose combination of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333 with or without ribavirin.
TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie’s three direct-acting antiviral regimen with ribavirin (RBV) in adult patients. Patients in the study were either new to therapy or treatment-experienced.
Patients achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. On-treatment virologic failure occurred in one patient (0.5%) in the 12-week arm and three patients (1.7%) in the 24-week arm. In addition, 12 patients (5.9%) in the 12-week arm and one patient (0.6%) in the 24-week arm experienced relapse within 12 weeks post-treatment.
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