Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES Infectious Diseases and Therapy Pub Date : 2024-04-28 DOI:10.1007/s40121-024-00968-5

Chun-Chi Yang, Chung-Feng Huang, Te-Sheng Chang, Ching-Chu Lo, Chao-Hung Hung, Chien-Wei Huang, Lee-Won Chong, Pin-Nan Cheng, Ming-Lun Yeh, Cheng-Yuan Peng, Chien-Yu Cheng, Jee-Fu Huang, Ming-Jong Bair, Chih-Lang Lin, Chi-Chieh Yang, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzong-Hsi Lee, Pei-Lun Lee, Wen-Chih Wu, Chih-Lin Lin, Wei-Wen Su, Sheng-Shun Yang, Chia-Chi Wang, Jui-Ting Hu, Lein-Ray Mo, Chun-Ting Chen, Yi-Hsiang Huang, Chun-Chao Chang, Chia-Sheng Huang, Guei-Ying Chen, Chien-Neng Kao, Chi-Ming Tai, Chun-Jen Liu, Mei-Hsuan Lee, Hsing-Tao Kuo, Pei-Chien Tsai, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wang-Long Chuang, Kuo-Chih Tseng, Chi-Yi Chen, Ming-Lung Yu

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Abstract

Introduction

Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR).

Methods

The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed.

Results

A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related.

Conclusion

Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.

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台湾一项全国性 HCV 登记研究显示，针对治疗无效患者的通用 8 周 Glecaprevir/Pibrentasvir 的实际疗效和安全性

导言为期八周的 glecaprevir/pibrentasvir (GLE/PIB) 适用于有或无代偿性肝硬化的慢性丙型肝炎（CHC）新患者（TN）。鉴于台湾政府致力于在 2025 年前消灭丙型肝炎病毒（HCV），本研究旨在衡量台湾 HCV 登记处（TACR）中使用 8 周 GLE/PIB 的 TN 患者的实际证据。在修正意向治疗（mITT）人群中评估了治疗效果，即治疗后第12周的持续病毒学应答（SVR12），其中排除了失去随访或缺乏SVR12数据的患者。结果共有 7246 例（6897 例无肝硬化；349 例有肝硬化）患者接受了至少一剂 GLE/PIB 治疗（ITT），其中 7204 例有 SVR12 数据（mITT）。所有患者的总 SVR12 率为 98.9%（7122/7204），无肝硬化和有肝硬化患者的 SVR12 率分别为 98.9%（6780/6856）和 98.3%（342/348）。在选定的亚组（包括基因型 3 感染者、糖尿病患者、慢性肾病患者、注射毒品者和合并人类免疫缺陷病毒感染者）中，SVR12 比率分别为 95.1%（272/286）、98.9%（1084/1096）、99.0%（1171/1183）、97.4%（566/581）和 96.1%（248/258）。总体而言，14.1%（1021/7246）的患者出现了不良事件（AE）。22名患者（0.3%）出现严重不良反应，15例（0.2%）导致永久停药。结论无论肝硬化状况如何，所有 TN 患者接受为期八周的 GLE/PIB 治疗均有效且耐受性良好。

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来源期刊

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

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.