Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan.
Journal
Infectious diseases and therapy
Journal Volume
13
Journal Issue
6
Start Page
1199
End Page
1213
ISSN
2193-8229
Date Issued
2024-06
Author(s)
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
Lee, Mei-Hsuan
Kuo, Hsing-Tao
Tsai, Pei-Chien
Dai, Chia-Yen
Lin, Han-Chieh
Chuang, Wang-Long
Tseng, Kuo-Chih
Chen, Chi-Yi
Yu, Ming-Lung
Abstract
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).
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.
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.
Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.
Subjects
Direct-acting antivirals
Glecaprevir
Hepatitis C
Pibrentasvir
Real world
Taiwan
SDGs
Type
journal article