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https://ir.csmu.edu.tw:8080/ir/handle/310902500/23381
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Title: | Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment |
Authors: | Liu, CH;Chen, CY;Su, WW;Tseng, KC;Lo, CC;Liu, CJ;Chen, JJ;Peng, CY;Shih, YL;Yang, SS;Huang, CS;Huang, KJ;Chang, CY;Tsai, MC;Kao, WY;Fang, YJ;Chen, PY;Su, PY;Tseng, CW;Huang, JJ;Lee, PL;Lai, HC;Hsieh, TY;Chang, CH;Huang, YJ;Lee, FJ;Chang, CC;Kao, JH |
Date: | 2021 |
Issue Date: | 2022-08-05T09:36:21Z (UTC)
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Publisher: | BMJ PUBLISHING GROUP |
ISSN: | 0017-5749 |
Abstract: | Objective Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI) are limited. We evaluated the performance of SOF/VEL with or without low-dose RBV in HCV-infected patients with chronic kidney disease stage 4 or 5. Design 191 patients with compensated (n=181) and decompensated (n=10) liver diseases receiving SOF/VEL (400/100 mg/day) alone and SOF/VEL with low-dose RBV (200 mg/day) for 12 weeks were retrospectively recruited at 15 academic centres in Taiwan. The effectiveness was determined by sustained virological response at off-treatment week 12 (SVR12) in evaluable (EP) and per-protocol populations (PP). The safety profiles were assessed. Results The SVR12 rates by EP and PP analyses were 94.8% (95% CI 90.6% to 97.1%) and 100% (95% CI 97.9% to 100%). In patients with compensated liver disease, the SVR12 rates were 95.0% and 100% by EP and PP analyses. In patients with decompensated liver disease, the SVR12 rates were 90.0% and 100% by EP and PP analyses. Ten patients who failed to achieve SVR12 were attributed to non-virological failures. Among the 20 serious adverse events (AEs), none were judged related to SOF/VEL or RBV. The AEs occurring in >= 10% included fatigue (14.7%), headache (14.1%), nausea (12.6%), insomnia (12.0%) and pruritus (10.5%). None had >= grade 3 total bilirubin or alanine aminotransferase elevations. Conclusion SOF/VEL with or without low-dose RBV is effective and well-tolerated in HCV-infected patients with severe RI. |
URI: | http://dx.doi.org/10.1136/gutjnl-2020-323569 https://www.webofscience.com/wos/woscc/full-record/WOS:000722675000001 https://ir.csmu.edu.tw:8080/handle/310902500/23381 |
Relation: | GUT ,2022,v71,issue 1, P176-184 |
Appears in Collections: | [中山醫學大學研究成果] 期刊論文
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