30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus in children ages 12 to 17. 

Mavyret was previously approved to treat hepatitis C virus infection in adults in 2017.

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Jeffrey Murray, M.D., M.P.H., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”

The safety and efficacy of Mavyret in paediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis.

Read FDA press release