The Food and Drug Administration (FDA) has approved Mavyret (glecaprevir and pibrentasvir; AbbVie) for the treatment of all 6 genotypes of hepatitis C virus (HCV) in children 12 to 17 years old or weighing at least 45kg. The treatment was initially approved in 2017 for adults with HCV.
Specifically, Mavyret is now approved for:
- Treatment of adult and pediatric patients ≥12 years old or weighing ≥45kg with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- Treatment of adult and pediatric patients ≥12 years or weighing ≥45kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both
The pediatric approval was based on data from an open-label clinical trial (DORA [Part 1]) that included 47 HCV patients aged 12 to <18 years without cirrhosis; 79% had HCV genotype 1, 6% had HCV genotype 2, 9% had HCV genotype 3, and 6% had HCV genotype 4. Patients received Mavyret for 8 or 16 weeks; 77% were treatment-naïve, while 23% were treatment-experienced to interferon.
Results of the study showed an overall SVR12 rate (defined as HCV RNA less than lower limit of quantification [LLOQ] at 12 weeks after the end of treatment) of 100% (47/47). In addition, the safety profile of Mavyret in pediatric patients was found to be consistent with that observed in adult patients.
As for pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV genotype 5 or 6 infection, the safety and efficacy of Mavyret were supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults.
Commenting on the expanded indication, Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research said, “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”
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. No dosage adjustment is required in pediatric patients ≥12 years old or weighing ≥45kg.
For more information visit mavyret.com.