Eight-Week Pan-Genotypic Treatment Option Approved for HCV Patients With Compensated Cirrhosis

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.

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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.

For more information visit abbvie.com.