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

• Status: Active, not recruiting
• Trial end date: 2022-11-21

Summary

This is a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics, efficacy,and safety of glecaprevir (GLE)/pibrentasvir (PIB) for 8, 12, or 16 weeks in Hepatitis C virus (HCV) genotype 1-6 (GT1 - GT6)-infected pediatric participants ≥ 3 to < 18 years of age, with or without compensated cirrhosis, with or without human immunodeficiency virus (HIV) coinfection, who were either treatment-naïve (TN), treatment-experienced (TE) with pegylated interferon (pegIFN) with or without ribavirin (RBV), or TE with sofosbuvir (SOF) + RBV with or without pegIFN. The study was divided into 2 parts, according to the formulation of GLE/PIB administered. Part 1 of the study enrolled HCV GT1 - GT6 infected adolescent participants into the ≥ 12 to < 18 years old age group who were willing to swallow the adult formulation of GLE/PIB (Cohort 1). Part 2 of the study enrolled HCV GT1 - GT6 infected pediatric participants divided into the ≥ 9 to < 12 (Cohort 2), ≥ 6 to < 9 (Cohort 3), and ≥ 3 to < 6 (Cohort 4) years old age groups, who received the pediatric formulation of GLE + PIB.

Interim data are presented for all participants in Parts 1 and 2 who completed post-treatment Week 12 or prematurely discontinued from the study.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: AbbVie
• Treatments: Interferons