Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in children with chronic hepatitis C virus: part 2 of the DORA study

Background and aims Glecaprevir/pibrentasvir (GLE/PIB) has shown high efficacy and safety in chronic hepatitis C virus (HCV)-infected adults and adolescents; data in children were limited. DORA part 2 is a phase 2/3, nonrandomized, open-label study evaluating the pharmacokinetics, efficacy, and safety of a pediatric formulation of glecaprevir (GLE) and pibrentasvir (PIB) in children ages 3 - Approach and results Children with chronic HCV infection, genotype (GT) 1-6, with or without compensated cirrhosis, were divided into 3 cohorts by age, cohort 2 (9 - Conclusions A pediatric formulation of GLE/PIB was highly efficacious and well-tolerated in chronic HCV-infected children 3 -