https://scholars.lib.ntu.edu.tw/handle/123456789/633102
標題: | Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry | 作者: | 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 CHIA-CHI WANG Hu, Jui Ting Mo, Lein Ray CHUN-TING CHEN Huang, Yi Hsiang Chang, Chun Chao Huang, Chia Sheng Chen, Guei Ying Kao, Chien Neng Tai, Chi Ming CHUN-JEN LIU Lee, Mei Hsuan Tsai, Pei Chien Dai, Chia Yen JIA-HORNG KAO Lin, Han Chieh Chuang, Wang Long Chen, Chi Yi Tseng, Kuo Chih Hung, Chao Hung Yu, Ming Lung |
關鍵字: | Compensated cirrhosis | GLE/PIB | HCV | Sustained virologic response | 公開日期: | 1-六月-2023 | 出版社: | SPRINGER | 卷: | 17 | 期: | 3 | 起(迄)頁: | 550 | 來源出版物: | Hepatology International | 摘要: | 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. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/633102 | ISSN: | 19360533 | DOI: | 10.1007/s12072-023-10506-z |
顯示於: | 臨床醫學研究所 |
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