中山醫學大學機構典藏 CSMUIR:Item 310902500/24877
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    题名: Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection and severe renal impairment
    作者: Liu, CH;Yang, SS;Peng, CY;Lin, WT;Liu, CJ;Su, TH;Tseng, TC;Chen, PJ;Chen, DS;Kao, JH
    关键词: chronic kidney disease;direct-acting antiviral agent;glecaprevir;hepatitis C virus;pibrentasvir
    日期: 2020
    上传时间: 2022-08-09T08:09:27Z (UTC)
    出版者: WILEY
    ISSN: 1352-0504
    摘要: Data are limited regarding the real-world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI). We aimed to evaluate the performance of GLE/PIB in patients with chronic kidney disease (CKD) stage 4 or 5 in Taiwan. 108 chronic HCV patients with CKD stage 4 (n = 32) or 5 (n = 76) receiving GLE/PIB for 8-12 weeks were retrospectively recruited at 4 academic centres in Taiwan. The effectiveness was determined by sustained virologic response at off-therapy week 12 (SVR12) for evaluable (EP) and per-protocol populations (PP). The safety profiles were also assessed. By EP and PP analyses, the SVR12 rate was 99.1% (107 of 108 patients; 95% confidence interval (CI): 94.9%-99.8%) and 100% (107 of 107 patients; 95% CI: 96.5%-100%). The SVR12 rates were 100% (95% CI: 89.3%-100%) and 98.7% (95% CI: 92.9%-99.8%) in patients with CKD stage 4 and 5, respectively. One patient, who declined off-therapy follow-up after permanently discontinuing GLE/PIB at on-treatment week 9 due to scheduled cardiac surgery, had nonvirologic failure. Sixteen (14.8%) patients had serious adverse events (AEs), which were judged not related to GLE/PIB. The three most common AEs were pruritus (19.4%), fatigue (15.7%) and nausea (13.9%). None had >= 3-fold upper limit of normal for total bilirubin and alanine aminotransferase levels. None of the 9 patients with hepatitis B virus (HBV) coinfection developed HBV-associated hepatitis. In conclusion, GLE/PIB for 8-12 weeks is effective and well-tolerated in HCV patients with severe RI.
    URI: http://dx.doi.org/10.1111/jvh.13265
    https://www.webofscience.com/wos/woscc/full-record/WOS:000511267200001
    https://ir.csmu.edu.tw:8080/handle/310902500/24877
    關聯: JOURNAL OF VIRAL HEPATITIS ,2020 ,v27 ,issue 6 ,p568-575
    显示于类别:[中山醫學大學研究成果] 期刊論文

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