Cirrhosis = compensated cirrhosis (Child-Pugh A), RBV = ribavirin, TE = treatment-experienced (patients who have failed a peginterferon alfa RBV–based regimen with or without an HCV protease inhibitor), TN = treatment-naïve Subjects were randomized in a 1:1:1:1 ratio to each of the treatment arms, and randomization was stratified by the presence or absence of cirrhosis, HCV genotype (1a vs 1b), and response to prior HCV therapy (relapse/breakthrough vs nonresponse).
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HARVONI Dosing Information Important Safety Information,including Contraindications, Warnings and Precautions, and Adverse Reactions Important Safety Information,including Contraindications, Warnings and Precautions, and Adverse Reactions ION-1: TN subjects (N=865) with or without cirrhosis were randomized to receive HARVONI for 12 weeks, HARVONI RBV for 12 weeks, HARVONI for 24 weeks, or HARVONI RBV for 24 weeks.
ION-2: TE subjects (N=440) with or without cirrhosis were randomized to receive HARVONI for 12 weeks, HARVONI RBV for 12 weeks, HARVONI for 24 weeks, or HARVONI RBV for 24 weeks.
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