학술논문
Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry
Document Type
Original Paper
Author
Chang, Te-Sheng; Huang, Chung-Feng; Kuo, Hsing-Tao; Lo, Ching-Chu; 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; Tsai, Pei-Chien; Dai, Chia-Yen; Kao, Jia-Horng; Lin, Han-Chieh; Chuang, Wang-Long; Chen, Chi-Yi; Tseng, Kuo-Chih; Hung, Chao-Hung; Yu, Ming-Lung
Source
Hepatology International. 17(3):550-561
Subject
Language
English
ISSN
1936-0533
1936-0541
1936-0541
Abstract
Background: Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naïve patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce.Methods: The TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naïve HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated.Results: Of the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/µl, and FibroScan > 20 kPa and platelet < 150,000/µl, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related.Conclusions: In this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naïve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.