FDA Approves New Option For Hep C in Children

The FDA has approved Mavyret (glecaprevir and pibrentasvir) tablets for the treatment of all 6 genotypes of hepatitis C virus in children aged 12 to 17 years. Mavyret was previously approved for the treatment of adults in 2017.

The safety and efficacy of Mavyret in pediatric patients was established in a trial involving 47 patients with genotypes 1, 2, 3, or 4 hepatitic C virus without cirrhosis or with mild cirrhosis. Overall, 100% of patients who received Mavyret for 8 or 16 weeks had no detectable virus in the blood 12 weeks after treatment. In patients with cirrhosis, history of kidney and/or liver transplant, or genotype 5 or 6, the safety and efficacy are supported by previous studies of glecaprevir and pibrentasvir in adults.

The most common adverse reactions associated with Mavyret were headache and fatigue.

—Michael Potts

Reference:

FDA approves first treatment for all genotypes of hepatitis C in pediatric patients [press release]. April 30, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-all-genotypes-hepatitis-c-pediatric-patients.