Treatment-naive adults with chronic hepatitis C virus (HCV) infection with genotypes 1-6 without cirrhosis or with compensated cirrhosis. Also indicated for treatment-experienced patients with HCV genotype 1 who have been previously treated with a regimen containing either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
Combination product that includes 2 new drugs, glecaprevir (HCV protease inhibitor) and pibrentasvir (NS5A inhibitor).
3 tablets (ie, 300 mg/120 mg total dose) PO once daily with food. Treatment duration ranges from 8 to 16 weeks and is dependent on treatment status, genotype, and presence of cirrhosis.
Approval was based on clinical trials involving nearly 2300 adults with chronic HCV. Sustained viral response at 12 weeks after treatment with glecaprevir/pibrentasvir ranged from 92-100%, indicative of a cure–regardless of whether treatment lasted 8, 12, or 16 weeks.
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.