Enanta announced results from the SAPPHIRE-I study, for the treatment of hepatitis C virus (HCV) genotype 1(GT1) infection using a regimen containing Enanta’s protease inhibitor ABT-450. ABT-450 is part of AbbVie‘s investigational three direct-acting antiviral (3D) regimen, consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333.
SAPPHIRE-I is a global, multi-center, randomized, double-blind, placebo-controlled study which evaluated 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 (150/100mg) co-formulated with ABT-267 (25mg) and dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-naïve adult patients. SAPPHIRE-I is one of six Phase 3 registrational studies being conducted by AbbVie for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection.
Results from the 631 patient SAPPHIRE-I trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96% (n=455/473) in treatment-naïve adult patients chronically infected with GT1 HCV. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 95% (307/322) and 98 percent (148/151), respectively. These results were based on an intent-to-treat analysis and were achieved after 12 weeks of treatment. The rate of virologic relapse or breakthrough was low, occurring in 1.7% of patients receiving the 3D regimen.