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FDA approves AbbVie's HCV regimen

December 20, 2014 3:14 AM UTC

FDA approved Viekira Pak from AbbVie Inc. (NYSE:ABBV) with or without ribavirin to treat HCV genotype 1 infection in patients with and without compensated cirrhosis. AbbVie set the WAC for the three direct-acting-antivral (3-DAA) treatment regimen at $83,319 for a 12-week course.

Viekira Pak includes two tablets: a fixed-dose combination of 25 mg of ombitasvir ( ABT-267), 150 mg of paritaprevir ( ABT-450), and 100 mg of the booster Norvir ritonavir dosed once daily; and 250 mg of dasabuvir ( ABT-333) dosed twice daily. The regimen also includes ribavirin for patients with HCV genotype 1a, and all genotype 1 patients who have cirrhosis or have received a liver transplant. ...