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在真实环境下,比较格卡瑞韦哌仑他韦/哌仑他韦 8 周与 12 周治疗台湾丙型肝炎合并代偿性肝硬化患者的疗效。

Comparison of 8- versus 12-weeks of glecaprevir/pibrentasvir for Taiwanese patients with hepatitis C and compensated cirrhosis in a real-world setting.

机构信息

Department of Internal Medicine, Division of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Chiayi, Taiwan.

College of Medicine, Chang Gung University, Taoyuan, Taiwan.

出版信息

PLoS One. 2022 Aug 18;17(8):e0272567. doi: 10.1371/journal.pone.0272567. eCollection 2022.

DOI:10.1371/journal.pone.0272567
PMID:35980912
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9387785/
Abstract

Real-world data on the effectiveness of glecaprevir/pibrentasvir (GLE/PIB) for patients with HCV infection and compensated cirrhosis is limited, especially for the 8-week regimen and in an Asian population. This retrospective study enrolled 159 consecutive patients with HCV and compensated cirrhosis who were treated with GLE/PIB at a single center in Taiwan. Sustained virological response (SVR) and adverse events (AEs) were evaluated. Among the 159 patients, 91 and 68 were treated with GLE/PIB for 8 and 12 weeks, respectively. In the per protocol analysis, both the 8- and 12-week groups achieved 100% SVR (87/87 vs. 64/64); and in the evaluable population analysis, 95.6% (87/91) of the 8-week group and 94.1% (64/68) of the 12-week group achieved SVR. The most commonly reported AEs, which included pruritus (15.4% vs. 26.5%), abdominal discomfort (9.9% vs. 5.9%), and skin rash (5.5% vs. 5.9%), were mild for the 8- and 12-week groups. Two patients in the 8-week group exhibited total bilirubin elevation over three times the upper normal limit. One of these two patients discontinued GLE/PIB treatment after 2 weeks but still achieved SVR. Both 8- and 12-week GLE/PIB treatments are safe and effective for patients of Taiwanese ethnicity with HCV and compensated cirrhosis.

摘要

真实世界中关于 Glecaprevir/pibrentasvir(GLE/PIB)治疗 HCV 感染合并代偿性肝硬化患者的疗效数据有限,尤其是 8 周疗程和亚洲人群的数据。本回顾性研究纳入了在台湾的一家单中心接受 GLE/PIB 治疗的 159 例连续 HCV 合并代偿性肝硬化患者。评估了持续病毒学应答(SVR)和不良事件(AE)。在这 159 例患者中,91 例和 68 例分别接受了 8 周和 12 周的 GLE/PIB 治疗。在方案预设分析中,8 周组和 12 周组均达到了 100%的 SVR(87/87 与 64/64);在可评估人群分析中,8 周组的 95.6%(87/91)和 12 周组的 94.1%(64/68)达到了 SVR。最常见的报告 AE 包括瘙痒(15.4%比 26.5%)、腹部不适(9.9%比 5.9%)和皮疹(5.5%比 5.9%),在 8 周和 12 周组中均为轻度。8 周组中有 2 例患者总胆红素升高超过正常值上限的 3 倍。这 2 例患者中有 1 例在治疗 2 周后停止了 GLE/PIB 治疗,但仍达到了 SVR。GLE/PIB 治疗 8 周和 12 周对台湾 HCV 合并代偿性肝硬化患者均安全有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/57186ffc78b0/pone.0272567.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/29b09e127dec/pone.0272567.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/d47b1e864a4d/pone.0272567.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/57186ffc78b0/pone.0272567.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/29b09e127dec/pone.0272567.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/d47b1e864a4d/pone.0272567.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2b/9387785/57186ffc78b0/pone.0272567.g003.jpg

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本文引用的文献

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