Jin-Woo Lee, Sang Hoon Ahn, Jeong Gil Park, Jae Youn Jeong, Ki Tae Yoon, Won Young Tak, Yang Hyun Baek, Su Jong Yu, Myeong Jun Song, Yeon Seok Seo, Ji Young Jeong, Jeong Heo
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引用次数: 0
Abstract
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.
期刊介绍：
Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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