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索磷布韦/维帕他韦和索磷布韦/达卡他韦治疗失代偿期肝硬化丙型肝炎患者的安全性和疗效。

Safety and efficacy of sofosbuvir/ledipasvir and sofosbuvir/daclatasvir in the treatment of hepatitis C in patients with decompensated cirrhosis.

机构信息

Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo.

Tropical medicine, Faculty of Medicine, Alexandria University, Alexandria.

出版信息

Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e877-e882. doi: 10.1097/MEG.0000000000002287.

Abstract

BACKGROUND

Hepatitis C virus (HCV)-related decompensated cirrhosis is a severe life-threatening illness. The safety of direct-acting antivirals (DAAs) has opened a gate of hope for that subgroup of patients who were previously contraindicated for interferon therapy.

OBJECTIVE

We aimed at the investigation of the safety and efficacy of different DAAs regimens in the treatment of HCV-related decompensated cirrhosis patients, to determine sustained virological response (SVR)12 rates and to analyze the factors associated with response.

METHODS

A retrospective, single-center study including HCV-related decompensated cirrhosis patients who received DAAs. Demographic, laboratory and clinical data were analyzed. The SVR12 rate was the primary outcome measure. Secondary outcomes included the predictors of response, changes in the baseline model for end-stage liver disease and child-turcotte-pugh (CTP) scores, and fibroindices (APRI and fibrosis-4 index) at 12 weeks after treatment.

RESULTS

In total, 145 eligible patients (141 with CTP class B and 4 with class C) were enrolled in this study. SVR12 was achieved by 88.06% (118/134) of efficacy population on different DAAs regimens, Treatment was discontinued in 11 patients because of severe side effects without any deaths. Younger age showed a significant positive association with SVR12.

CONCLUSIONS

DAAs can be used for the treatment of HCV-related decompensated liver disease, with acceptable SVR12 rates and safety profiles.

摘要

背景

丙型肝炎病毒(HCV)相关失代偿性肝硬化是一种严重的危及生命的疾病。直接作用抗病毒药物(DAA)的安全性为那些以前干扰素治疗禁忌的患者群体打开了希望之门。

目的

我们旨在研究不同 DAA 方案治疗 HCV 相关失代偿性肝硬化患者的安全性和疗效,以确定持续病毒学应答(SVR)12 率,并分析与应答相关的因素。

方法

这是一项回顾性、单中心研究,纳入了接受 DAA 治疗的 HCV 相关失代偿性肝硬化患者。分析了人口统计学、实验室和临床数据。SVR12 率是主要观察指标。次要结局包括应答的预测因素、基线终末期肝病模型(MELD)和 Child-Turcotte-Pugh(CTP)评分的变化,以及治疗后 12 周的纤维化指数(APRI 和纤维化-4 指数)。

结果

共有 145 名符合条件的患者(141 名 CTP 分级 B 和 4 名 CTP 分级 C)纳入本研究。不同 DAA 方案的有效人群中,有 88.06%(118/134)达到 SVR12。11 名患者因严重副作用而停止治疗,但无死亡病例。年龄较轻与 SVR12 呈显著正相关。

结论

DAA 可用于治疗 HCV 相关失代偿性肝病,具有可接受的 SVR12 率和安全性。

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