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https://ir.csmu.edu.tw:8080/ir/handle/310902500/23425
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Title: | Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan |
Authors: | Liu, CH;Chen, PY;Chen, JJ;Lo, CC;Su, WW;Tseng, KC;Liu, CJ;Huang, CS;Huang, KJ;Yang, SS;Peng, CY;Tsai, MC;Kao, WY;Chang, CY;Shih, YL;Fang, YJ;Chen, CY;Lee, PL;Huang, JJ;Su, PY;Tseng, CW;Hung, CC;Chang, CH;Huang, YJ;Lai, HC;Chang, CC;Lee, FJ;Hsieh, TY;Kao, JH |
Keywords: | Hepatitis C virus;Direct acting antiviral;Sofosbuvir;Velpatasvir;Sustained virologic response;Adverse event;East Asian;Effectiveness;Safety;Pangenotypic |
Date: | 2021 |
Issue Date: | 2022-08-05T09:37:04Z (UTC)
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Publisher: | SPRINGER |
ISSN: | 1936-0533 |
Abstract: | Background Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan. Methods Between July 2019 and March 2020, 1880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported. Results The SVR12 rates by EP and PP analyses were 95.6% [1798 of 1880 patients; 95% confidence interval (CI) 94.6-96.5%] and 99.3% (1798 of 1811 patients; 95% CI 98.8-99.6%), respectively. Among 82 patients who failed to achieve SVR12, 13 (15.9%) were attributed to virologic failures. The SVR12 rates were comparable regardless of baseline characteristics. A total of 1859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in >= 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations. Conclusions SOF/VEL for 12 weeks is efficacious and well-tolerated by chronic HCV-infected patients with compensated liver disease in Taiwan. |
URI: | http://dx.doi.org/10.1007/s12072-021-10158-x https://www.webofscience.com/wos/woscc/full-record/WOS:000625738000001 https://ir.csmu.edu.tw:8080/handle/310902500/23425 |
Relation: | HEPATOLOGY INTERNATIONAL ,2021,v15,issue 2, P338-349 |
Appears in Collections: | [中山醫學大學研究成果] 期刊論文
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