Enanta announced results from the Phase 3 SAPPHIRE-I and SAPPHIRE-II studies for AbbVie’s investigational three direct-acting antiviral regimen containing Enanta’s ABT-450 for the treatment of hepatitis C virus (HCV) genotype 1(GT1) infection at the International Liver Congress 2014. 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.
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-II is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with RBV in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients (n=395) who previously failed treatment with pegylated interferon and RBV. Patients initially randomized to placebo for the first 12 weeks then received open-label treatment with the three direct-acting antiviral regimen with RBV for 12 weeks.
In the SAPPHIRE-I (n=631) and SAPPHIRE-II (n=394) placebo-controlled studies, adult, non-cirrhotic patients with chronic genotype 1 hepatitis C virus infection receiving the investigational three-direct-acting antiviral regimen with ribavirin (RBV) for 12 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 96.2% (n=455/473) and 96.3% (n=286/297), respectively. The majority of patients were GT1a in SAPPHIRE-I, and the SVR12 rates of GT1a and GT1b were 95.3% (307/322) and 98% (148/151), respectively. In SAPPHIRE-II, the SVR12 rates of GT1a and GT1b were 96% (166/173) and 96.7% (119/123).