The FDA approval of glecaprevir/pibrentasvir (Mavyret, AbbVie, Inc.) represents another treatment option for children and adolescents with hepatitis C virus (HCV) infection. It is the first approval of a therapy for all HCV genotypes, without cirrhosis or with compensated cirrhosis.
Glecaprevir/pibrentasvir, previously approved in 2017 for adults with HCV, is now approved for adults and for children who are 12 years and older or weigh at least 99 pounds, who are infected with any of six known HCV genotypes. The drug’s side effects in children were similar to those observed in adult clinical trials. The most commonly reported adverse reactions were headache, fatigue, and nausea.
The approval was based on clinical trials of 47 pediatric patients with genotype 1, 2, 3, or 4 HCV infection who had no cirrhosis or mild cirrhosis. In trials, all patients receiving glecaprevir/pibrentasvir for eight weeks or 16 weeks showed no detectable virus in their blood 12 weeks after treatment completion.
Glecaprevir/pibrentasvir is not recommended in patients with moderate hepatic impairment (Child-Pugh B). It is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and in patients taking atazanavir and rifampin.
Source: BioSpace, May 1, 2019