Observational, Post-marketing Surveillance of Safety and Effectiveness of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C

INTRODUCTION: Glecaprevir/pibrentasvir (G/P) is a pan-genotypic, interferon-free, direct-acting antiviral regimen approved for chronic hepatitis C (CHC) treatment. While clinical trials have demonstrated its efficacy and safety, real-world data in the Korean population remain limited. This post-marketing surveillance study aimed to evaluate the safety and effectiveness of G/P in Korean patients with CHC in routine clinical practice. METHODS: A prospective, multicenter observational study was conducted across 56 institutions in Korea from January 2018 to January 2024. Adult and adolescent patients (aged ≥ 12 years) with CHC receiving G/P were enrolled. Safety outcomes evaluated adverse events (AEs), including serious AEs (SAEs), and treatment-related AEs. Effectiveness was assessed by sustained virologic response at 12 weeks post-treatment (SVR12) in evaluable patients. RESULTS: Of 3061 patients enrolled, 51.1% were female and 18.6% had cirrhosis. AEs were reported in 9.7% of patients, with pruritus (2.0%) and headache (1.0%) being most common. SAEs occurred in 1.2% of patients, and 0.3% discontinued treatment due to AEs. No new safety signals were identified. SVR12 was achieved in 98.2% of the effectiveness population (n = 2434). Among patients whose hepatitis C virus RNA was monitored during therapy, on-treatment virologic failure occurred in 1.3%, while post-treatment relapse was observed in 1.2%. CONCLUSIONS: G/P therapy demonstrated a manageable safety profile and high effectiveness in Korean patients with CHC in real-world settings, supporting its continued use and coverage under national health programs. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov (NCT03740230).