ArticleInfectious diseases and therapy2026
Observational, Post-marketing Surveillance of Safety and Effectiveness of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740230 (Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the "Standard for Re-examination of New Drugs"
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12 authors.
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Abstract
introductionGlecaprevir/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.
methodsA 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.
resultsOf 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%.
conclusionsG/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).
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