The Food and Drug Administration (FDA) has expanded the approval of Mavyret (glecaprevir and pibrentasvir; AbbVie), shortening the treatment duration from 12 weeks to 8 weeks in treatment-naïve adults and children 12 years of age and older with chronic hepatitis C and compensated cirrhosis across all HCV genotypes.
The approval was based on data from the phase 3b EXPEDITION-8 study that evaluated the efficacy and safety of Mavyret for 8 weeks in treatment-naïve HCV patients (genotypes 1-6) with compensated cirrhosis (N=343). The primary end point of the study was sustained virologic response 12 weeks after treatment (SVR12) rates in patients across all genotypes vs historical SVR12 rates based on efficacy with a 12-week regimen. Results showed that overall, 98% (n=335/343) of patients achieved SVR12 with the 8-week regimen.
“This approval provides a treatment duration of 8 weeks for both pediatric and adult patients with compensated cirrhosis regardless of HCV genotype; meaning that an 8-week treatment regimen is available for any treatment-naïve HCV patient, regardless of cirrhosis status or genotype,” said Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
Mavyret is a once-daily treatment that combines glecaprevir, an HCV NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. Both direct-acting antivirals work by targeting and inhibiting proteins required for HCV replication.
Mavyret is available as 100mg/40mg fixed-dose tablets in a 4-week (monthly) or 8-week carton. Each carton contains 7 daily dose wallets.
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