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慢性丙型肝炎感染患者使用通用型直接抗病毒药物治疗后持续病毒学应答的肝病结局

Liver Disease Outcomes after Sustained Virological Response in Patients with Chronic Hepatitis C Infection Treated with Generic Direct-Acting Antivirals.

作者信息

El-Wahab Ekram W Abd, Elgawad Waleed M Abd, Abdelaziz Mohamed S, Mikheal Ashraf I, Shatat Hanan Z

机构信息

Department of Tropical Health, High Institute of Public Health, Alexandria University, Alexandria, Egypt.

High Institute of Public Health, Alexandria University, Alexandria, Egypt.

出版信息

Am J Trop Med Hyg. 2022 Feb 28;106(5):1522-33. doi: 10.4269/ajtmh.21-0918.

DOI:10.4269/ajtmh.21-0918
PMID:35226870
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9128674/
Abstract

The introduction of generic direct-acting antivirals (DAAs) in Egypt is associated with a superior cure rate of hepatitis C virus (HCV) infection. However, the course of progressive liver damage and developing liver related complications in patients with sustained virologic response (SVR) remain unclear. This study was designed to examine the long-term outcomes of generic DAA-induced virological cure in a real-life cohort of HCV patients with or without comorbid schistosomiasis. We prospectively enrolled a cohort of 506 recently cured HCV patients (437 Child-Pugh class A [Child-A] and 69 Child-Pugh class B [Child-B]). All patients were clinically evaluated at different time points during a 2-year follow-up (November 2018 to February 2021). Over the course of treatment and follow-up, 77 (15.2%) patients (42 [9.6%] Child-A and 35 [50.7%] Child-B) experienced complications at different time points. The overall mortality rate was approximately 1/1,000 person-years. The incidence of hepatic insufficiency was approximately 5.5/1,000 person-years, and that of de novo hepatocellular carcinoma (HCC) was approximately 8.3/1,000 person-years. A sustained improvement in liver indices up to 2 years of follow-up was observed. In the Cox regression model, pretreatment decompensated cirrhosis predicted the occurrence of adverse liver events and HCC after therapy. In conclusion, in HCV patients with advanced cirrhosis or coexisting hepatic schistosomiasis, generic DAA-induced SVR remains robust with favorable clinical outcomes although the risk of hepatocarcinogenesis cannot be eliminated. Surveillance of patients with treated HCV infection is an important aspect of postcure care for early detection and management of liver disease-related adverse events.

摘要

在埃及引入仿制药直接抗病毒药物(DAA)与丙型肝炎病毒(HCV)感染的更高治愈率相关。然而,持续病毒学应答(SVR)患者的进行性肝损伤病程以及发生肝脏相关并发症的情况仍不清楚。本研究旨在调查在有或无合并血吸虫病的HCV患者真实队列中,仿制药DAA诱导病毒学治愈的长期结局。我们前瞻性纳入了一组506例近期治愈的HCV患者(437例Child-Pugh A级[Child-A]和69例Child-Pugh B级[Child-B])。在2年随访期间(2018年11月至2021年2月)的不同时间点对所有患者进行了临床评估。在治疗和随访过程中,77例(15.2%)患者(42例[9.6%] Child-A和35例[50.7%] Child-B)在不同时间点出现了并发症。总死亡率约为1/1000人年。肝功能不全的发生率约为5.5/1000人年,新发肝细胞癌(HCC)的发生率约为8.3/1000人年。观察到随访长达2年时肝脏指标持续改善。在Cox回归模型中,治疗前失代偿性肝硬化可预测治疗后不良肝脏事件和HCC的发生。总之,在晚期肝硬化或合并肝血吸虫病的HCV患者中,尽管不能消除肝癌发生风险,但仿制药DAA诱导的SVR仍然稳固,临床结局良好。对接受HCV感染治疗的患者进行监测是治愈后护理的一个重要方面,以便早期发现和管理肝脏疾病相关不良事件。

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本文引用的文献

1
Egypt's Ambitious Strategy to Eliminate Hepatitis C Virus: A Case Study.埃及消除丙型肝炎病毒的宏伟战略:案例研究。
Glob Health Sci Pract. 2021 Mar 31;9(1):187-200. doi: 10.9745/GHSP-D-20-00234.
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Liver-related effects of chronic hepatitis C antiviral treatment.慢性丙型肝炎抗病毒治疗的肝脏相关效应。
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Long-Term Follow-Up of Advanced Liver Disease after Sustained Virological Response to Treatment of Hepatitis C with Direct-Acting Antivirals: Outcomes from a Real-World Portuguese Cohort.丙型肝炎直接抗病毒治疗获得持续病毒学应答后晚期肝病的长期随访:来自葡萄牙真实世界队列的结果
GE Port J Gastroenterol. 2020 Apr;27(3):149-159. doi: 10.1159/000503074. Epub 2019 Oct 10.
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Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview.埃及肝细胞癌 (HCC):全面概述。
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Management of patients with pre-therapeutic advanced liver fibrosis following HCV eradication.丙型肝炎病毒清除后治疗前晚期肝纤维化患者的管理。
JHEP Rep. 2019 Nov 18;1(6):480-489. doi: 10.1016/j.jhepr.2019.11.001. eCollection 2019 Dec.
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Sofosbuvir-/Daclatasvir-based therapy for chronic HCV and HCV/hepatitis B virus coinfected patients in Egypt.索磷布韦/达卡他韦方案治疗埃及慢性丙型肝炎及丙型肝炎/乙型肝炎病毒合并感染患者。
Trans R Soc Trop Med Hyg. 2020 Feb 7;114(3):200-212. doi: 10.1093/trstmh/trz079.
7
Treatment Status of Hepatocellular Carcinoma Does Not Influence Rates of Sustained Virologic Response: An HCV-TARGET Analysis.肝细胞癌的治疗状态不影响持续病毒学应答率:一项丙型肝炎病毒治疗和消除研究小组(HCV-TARGET)分析
Hepatol Commun. 2019 Aug 7;3(10):1388-1399. doi: 10.1002/hep4.1412. eCollection 2019 Oct.
8
Incidence and risk factors of early HCC occurrence in HCV patients treated with direct acting antivirals: a prospective multicentre study.直接作用抗病毒药物治疗的 HCV 患者中 HCC 早期发生的发生率和风险因素:一项前瞻性多中心研究。
J Transl Med. 2019 Aug 28;17(1):292. doi: 10.1186/s12967-019-2033-x.
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Increased Risk for Hepatocellular Carcinoma Persists Up to 10 Years After HCV Eradication in Patients With Baseline Cirrhosis or High FIB-4 Scores.在基线肝硬化或高 FIB-4 评分的患者中,HCV 清除后长达 10 年仍存在肝细胞癌风险增加。
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Hepatology. 2020 Jan;71(1):44-55. doi: 10.1002/hep.30823. Epub 2019 Aug 19.