AbbVie announced Phase 3 results for its investigational three direct-acting antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection. The investigational 3D regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333.
SAPPHIRE-II is a global, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 12 weeks of treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice daily, and the fixed-dose combination of ABT-450/ritonavir (150mg/100mg) co-formulated with ABT-267 (25mg) and dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients who previously failed treatment with pegylated interferon and ribavirin. Patients were initially randomized to placebo for the first 12 weeks then received open-label treatment with the 3D regimen plus ribavirin for 12 weeks. In the study, 49% of patients were prior null responders to pegylated interferon and ribavirin.
Following 12 weeks of treatment with the 3D regimen plus ribavirin, 96% (n=286/297) of patients achieved SVR12 based on an intent-to-treat analysis where patients with missing values for any reason were considered treatment failures. The SVR12 rates in GT1a and GT1b patients were 96% (n=166/173) and 97% (n=119/123), respectively. One subject had HCV genotype 1 and achieved SVR12, but was unable to be subgenotyped. Virologic relapse or breakthrough was noted in 2% of patients receiving the 3D regimen plus ribavirin.
SAPPHIRE-II is the second placebo-controlled trial and the second of six Phase 3 trials supporting AbbVie’s investigational 3D regimen for the treatment of GT1 hepatitis C patients.
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