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AbbVie Inc demonstrates 96 pct SVR(12) in its phase III study of treatment-experienced patients with Genotype 1 Hepatitis C


Tuesday, 10 Dec 2013 08:01am EST 

AbbVie Inc:Says phase III results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection.Says in the 394-patient SAPPHIRE-II study, 96 pct of patients who previously failed pegylated interferon and ribavirin treatment, including about 49 pct of who were prior null responders, achieved sustained virologic response at 12 weeks (SVR12) with the regimen.Says the majority of patients were GT1a, considered a difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96 pct and 97 pct, respectively.Says Virologic relapse was noted in 2 pct of patients receiving the 3D regimen plus ribavirin.Says in addition, the discontinuation rate due to adverse events was 1 pct.Says following SAPPHIRE-I, SAPPHIRE-II is the second placebo-controlled trial and the second of six phase III trials supporting AbbVie's investigational 3D regimen for the treatment of GT1 hepatitis C patients. 

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