台湾全国丙型肝炎登记处中初治患者使用通用型8周格卡瑞韦/哌仑他韦的真实世界疗效和安全性
Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan.
作者信息
Yang Chun-Chi, Huang Chung-Feng, Chang Te-Sheng, Lo Ching-Chu, Hung Chao-Hung, Huang Chien-Wei, Chong Lee-Won, Cheng Pin-Nan, Yeh Ming-Lun, Peng Cheng-Yuan, Cheng Chien-Yu, Huang Jee-Fu, Bair Ming-Jong, Lin Chih-Lang, Yang Chi-Chieh, Wang Szu-Jen, Hsieh Tsai-Yuan, Lee Tzong-Hsi, Lee Pei-Lun, Wu Wen-Chih, Lin Chih-Lin, Su Wei-Wen, Yang Sheng-Shun, Wang Chia-Chi, Hu Jui-Ting, Mo Lein-Ray, Chen Chun-Ting, Huang Yi-Hsiang, Chang Chun-Chao, Huang Chia-Sheng, Chen Guei-Ying, Kao Chien-Neng, Tai Chi-Ming, Liu Chun-Jen, Lee Mei-Hsuan, Kuo Hsing-Tao, Tsai Pei-Chien, Dai Chia-Yen, Kao Jia-Horng, Lin Han-Chieh, Chuang Wang-Long, Tseng Kuo-Chih, Chen Chi-Yi, Yu Ming-Lung
机构信息
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Yongkang District, Tainan, Taiwan.
Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, Taiwan.
出版信息
Infect Dis Ther. 2024 Jun;13(6):1199-1213. doi: 10.1007/s40121-024-00968-5. Epub 2024 Apr 28.
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.
引言
8周的格卡瑞韦/哌仑他韦（GLE/PIB）适用于初治（TN）的慢性丙型肝炎（CHC）患者，无论有无代偿性肝硬化。鉴于台湾政府致力于在2025年前消除丙型肝炎病毒（HCV），本研究旨在通过台湾丙型肝炎注册研究（TACR）评估TN患者使用8周GLE/PIB的真实世界证据。
方法
从台湾肝病研究协会（TASL）组织的一项全国性注册研究项目TACR中检索接受8周GLE/PIB治疗的CHC患者的数据。在改良意向性治疗（mITT）人群中评估治疗效果，定义为治疗后第12周的持续病毒学应答（SVR12），该人群排除了失访或缺乏SVR12数据的患者。评估意向性治疗（ITT）人群的安全性。
结果
共有7246名（6897名无肝硬化；349名有肝硬化）患者接受了至少一剂GLE/PIB（ITT），其中7204名患者有SVR12数据（mITT）。所有患者的总体SVR12率为98.9%（7122/7204），无肝硬化患者和有肝硬化患者的SVR12率分别为98.9%（6780/6856）和98.3%（342/348）。对于选定的亚组，包括基因3型感染患者、糖尿病患者、慢性肾脏病患者、注射吸毒者以及合并人类免疫缺陷病毒感染的患者，SVR12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）的患者发生了不良事件（AE）。22名患者（0.3%）发生了严重AE，15起事件（0.2%）导致永久停药。只有1起事件被认为与治疗药物相关。
结论
8周的GLE/PIB治疗对所有TN患者均有效且耐受性良好，无论其肝硬化状态如何。
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