A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir
(GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to
< 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be
enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age
group and the remainder of participants will be enrolled for the evaluation of safety and
efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment,
based on available PK and clinical data to achieve therapeutic exposures that have been safe
and efficacious in adults.

Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include
participants who are in 12 to < 18 years of age who can swallow the adult formulation of
GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into
Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of
GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their
hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.