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Phase III data for AbbVie's all-oral HCV regimen

November 19, 2013 1:56 AM UTC

AbbVie Inc. (NYSE:ABBV) reported data on Monday from the Phase III SAPPHIRE-1 (Study M11-646) trial evaluating an all-oral regimen of three of its antivirals plus ribavirin for 12 weeks to treat HCV genotype 1 infection in treatment- naïve patients with no evidence of liver cirrhosis. In 473 patients in the active treatment arm, the regimen -- ABT-450 boosted with AbbVie's Norvir ritonavir, ABT-267 and ABT-333 -- with ribavirin for 12 weeks produced a sustained virologic response (SVR) 12 weeks after the end of treatment in 96% of patients. SVR12 rates were 95% in patients with HCV genotype 1a infection (n=322) and 98% in patients with HCV genotype 1b infection (n=151).

SAPPHIRE-I is the first of six trials in AbbVie's Phase III program evaluating the triple combination regimen with and without ribavirin in more than 2,300 treatment-naïve and treatment-experienced patients with HCV genotype 1 infection. The company plans to report data from the remaining five trials in the "coming months," with regulatory submissions slated to start in 2Q14. In May, FDA granted breakthrough therapy designation for the triple combination therapy with and without ribavirin to treat HCV genotype 1 infection. ABT-450 is an HCV NS3/4A protease inhibitor, ABT-267 is an HCV NS5A protein inhibitor and ABT-333 is a non-nucleoside HCV NS5B polymerase inhibitor. ...