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格卡瑞韦/哌仑他韦治疗慢性丙型肝炎相关代偿期肝硬化的真实世界经验:一项多中心回顾性研究

Real-World Experience of Chronic Hepatitis C-Related Compensated Liver Cirrhosis Treated with Glecaprevir/Pibrentasvir: A Multicenter Retrospective Study.

作者信息

Su Pei-Yuan, Chen Yang-Yuan, Lai Jun-Hung, Chen Hung-Ming, Yao Chih-Ta, Liu I-Ling, Zeng Ya-Huei, Huang Siou-Ping, Hsu Yu-Chun, Wu Shun-Sheng, Siao Fu-Yuan, Yen Hsu-Heng

机构信息

Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua 500, Taiwan.

Division of Gastroenterology, Department of Internal Medicine, Yuanlin Christian Hospital, Changhua 500, Taiwan.

出版信息

J Clin Med. 2021 Nov 10;10(22):5236. doi: 10.3390/jcm10225236.

Abstract

BACKGROUND

Glecaprevir/pibrentasvir is a protease inhibitor-containing pangenotypic direct-acting antiviral regimen that has been approved for the treatment of chronic hepatitis C. The present study aimed to evaluate the safety and efficacy of glecaprevir/pibrentasvir in patients with compensated cirrhosis in a real-world setting.

METHODS

We evaluated the real-world safety and efficacy of glecaprevir/pibrentasvir in patients with compensated cirrhosis from five hospitals in the Changhua Christian Care System, who underwent treatment between August 2018 and October 2020. The primary endpoint was a sustained virological response observed 12 weeks after completion of the treatment.

RESULTS

Ninety patients, including 70 patients who received the 12-week therapy and 20 patients who received the 8-week therapy, were enrolled. The mean age of the patients was 65 years, and 57.8% of the patients were males. Sixteen (17.8%) patients had end-stage renal disease, and 15 (16.7%) had co-existing hepatoma. The hepatitis C virus genotypes 1 (40%) and 2 (35.6%) were most common. The common side effects included anorexia (12.2%), pruritus (7.8%), abdominal discomfort (7.8%), and malaise (7.8%). Laboratory adverse grade ≥3 events included anemia (6.3%), thrombocytopenia (5.1%), and jaundice (2.2%). The overall sustained virological response rates were 94.4% and 97.7% in the intention-to-treat and per-protocol analyses, respectively.

CONCLUSIONS

the glecaprevir/pibrentasvir treatment regimen was highly effective and well tolerated among patients with compensated cirrhosis in the real-world setting.

摘要

背景

格卡瑞韦/哌柏西利是一种含蛋白酶抑制剂的泛基因型直接抗病毒方案,已被批准用于治疗慢性丙型肝炎。本研究旨在评估格卡瑞韦/哌柏西利在真实世界中对代偿期肝硬化患者的安全性和疗效。

方法

我们评估了彰化基督教医疗体系五家医院中接受治疗的代偿期肝硬化患者使用格卡瑞韦/哌柏西利的真实世界安全性和疗效。这些患者在2018年8月至2020年10月期间接受了治疗。主要终点是治疗完成后12周观察到的持续病毒学应答。

结果

共纳入90例患者,其中70例接受12周治疗,20例接受8周治疗。患者的平均年龄为65岁,57.8%为男性。16例(17.8%)患者患有终末期肾病,15例(16.7%)患有合并肝癌。丙型肝炎病毒基因型1(40%)和2(35.6%)最为常见。常见的副作用包括厌食(12.2%)、瘙痒(7.8%)、腹部不适(7.8%)和乏力(7.8%)。实验室不良≥3级事件包括贫血(6.3%)、血小板减少(5.1%)和黄疸(2.2%)。在意向性分析和符合方案分析中,总体持续病毒学应答率分别为94.4%和97.7%。

结论

在真实世界中,格卡瑞韦/哌柏西利治疗方案在代偿期肝硬化患者中具有高效性和良好的耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af6a/8619604/30596877e05f/jcm-10-05236-g001.jpg

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