Scholarlink

Introduction <p>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.</p> Methods <p>A prospective, multicenter observational study was conducted across 56 institutions in Korea from January 2018 to January 2024. Adult and adolescent patients (aged ≥ 12&#xa0;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&#xa0;weeks post-treatment (SVR12) in evaluable patients.</p> Results <p>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 (<i>n</i> = 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%.</p> Conclusions <p>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.</p> Clinical Trials Registration <p>ClinicalTrials.gov (NCT03740230).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月8日

查看全文
  • 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

摘要

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).