https://scholars.lib.ntu.edu.tw/handle/123456789/581702
標題: | Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan | 作者: | CHEN-HUA LIU Chen P.-Y. Chen J.-J. Lo C.-C. Su W.-W. Tseng K.-C. CHUN-JEN LIU Huang C.-S. Huang K.-J. Yang S.-S. Peng C.-Y. Tsai M.-C. Kao W.-Y. Chang C.-Y. Shih Y.-L. YU-JEN FANG Chen C.-Y. Lee P.-L. Huang J.-J. Su P.-Y. Tseng C.-W. CHIEN-CHING HUNG Chang C.-H. Huang Y.-J. Lai H.-C. Chang C.-C. Lee F.-J. Hsieh T. Y. JIA-HORNG KAO |
公開日期: | 2021 | 出版社: | Springer | 卷: | 15 | 期: | 2 | 起(迄)頁: | 338-349 | 來源出版物: | Hepatology International | 摘要: | 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. ? 2021, Asian Pacific Association for the Study of the Liver. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85102073246&doi=10.1007%2fs12072-021-10158-x&partnerID=40&md5=927c339405c5269d8081ebc61bc21c24 https://scholars.lib.ntu.edu.tw/handle/123456789/581702 |
ISSN: | 1936-0533 | DOI: | 10.1007/s12072-021-10158-x | SDG/關鍵字: | alanine aminotransferase; bilirubin; sofosbuvir plus velpatasvir; antivirus agent; carbamic acid derivative; fused heterocyclic rings; sofosbuvir; velpatasvir; ablation therapy; adult; aged; alanine aminotransferase blood level; Article; bilirubin blood level; Child Pugh score; chronic hepatitis C; compensated liver cirrhosis; diarrhea; drug efficacy; drug safety; fatigue; female; human; insomnia; liver cell carcinoma; major clinical study; male; middle aged; multicenter study; nausea; population research; side effect; Taiwan; treatment response; complication; epidemiology; genetics; genotype; Hepacivirus; sustained virologic response; Antiviral Agents; Carbamates; Genotype; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Rings; Humans; Sofosbuvir; Sustained Virologic Response; Taiwan |
顯示於: | 臨床醫學研究所 |
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