Enanta announced results from the PEARL-III trial studying ABT-450 for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection using a three direct-acting (3D) antiviral regimen. 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.
PEARL-III is one of the six Phase 3 registrational studies conducted by AbbVie for the treatment of GT1 HCV infection using a regimen containing Enanta’s lead protease inhibitor ABT-450. The study is a global, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie’s regimen with and without RBV in non-cirrhotic, GT1b HCV-infected, treatment-naïve adult patients (n=419).
The PEARL-III study met its primary endpoint. Following 12 weeks of treatment, 99% receiving the regimen without RBV (n=207/209) and 99.5% receiving the regimen with RBV (n=209/210) achieved SVR12. Patients in the treatment arm without RBV received placebo in substitution for RBV.
Across treatment arms in PEARL-III, there were no documented relapses within 12 weeks post-treatment. No on-treatment virologic failures occurred in the treatment arm without RBV and a single virologic failure occurred in the treatment arm with RBV. While all patients in the study completed therapy, two patients in the arm without RBV were lost to follow-up and therefore were considered treatment failures.
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