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Enanta Pharmaceuticals Inc announces 96 pct SVR12 in treatment experienced Genotype 1 Hepatitis C Patients in SAPPHIRE-II study


Tuesday, 10 Dec 2013 08:02am EST 

Enanta Pharmaceuticals Inc:Says results from the SAPPHIRE-II study, the second of six phase three registrational studies being conducted by AbbVie for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, using a regimen containing Enanta`s lead protease inhibitor ABT-450.Says 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.Says the SAPPHIRE-II study used this 3D regimen plus ribavirin.Says results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 pct in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment.Says about 49 pct of these patients were prior null responders, namely patients defined as not achieving a significant reduction in the HCV virus during their prior treatment.Says following SAPPHIRE-I, SAPPHIRE-II is the second placebo-controlled trial and the second of six phase three trials supporting AbbVie`s investigational 3D regimen for the treatment of GT1 hepatitis C patients.