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中东地区丙型肝炎的消除:直接作用抗病毒疗法疗效的叙述性综述

Elimination of hepatitis C in the Middle East: a narrative review of the efficacy of direct-acting antiviral therapies.

作者信息

Coxeter-Smith Catherine, Gaglani Ria B, Ingram Robert D, Kidd Oliver T, Kumar Anjana S, Alhadad Amin, Alrubaiy Laith

机构信息

Imperial College London, South Kensington, London, UK.

General Internal Medicine, Western General Hospital, Edinburgh, UK.

出版信息

Transl Gastroenterol Hepatol. 2025 Jan 9;10:10. doi: 10.21037/tgh-24-87. eCollection 2025.

DOI:10.21037/tgh-24-87
PMID:39944590
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11811564/
Abstract

BACKGROUND AND OBJECTIVE

Hepatitis C virus (HCV), is a major health concern in the Middle East. Recent advances in direct-acting antivirals (DAAs) have transformed the treatment of HCV. The DAA chosen depends on the HCV genotype (GT) responsible for the infection, presence of cirrhosis, and prior treatment attempts. In addition, factors such as human immunodeficiency virus (HIV) co-infection and renal impairment can influence treatment. This literature review aims to discuss and appraise evidence on the efficacy and safety of the DAAs currently licensed for hepatitis C treatment in the Middle East.

METHODS

Supporting publications from the National Institute for Health and Care Excellence (NICE) and European Association for the Study of the Liver guidelines were searched manually. A literature search of PubMed, MEDLINE, Cochrane Library, and EMBASE databases was performed with search terms including 'HCV', 'clinical trial', and the seven combinations of DAA combinations recommended by NICE. Papers from January 2016 to January 2021 were considered, along with seminal papers outside this range.

KEY CONTENT AND FINDINGS

Of 390 publications found, 62 were included. In most studies, DAAs showed high efficacy in the recommended GTs, cirrhosis states, and prior HCV treatments. DAAs were found to be generally safe and well-tolerated: the most common side effects throughout were headache and nausea. Serious adverse events (SAEs) were seen when ribavirin and peginterferon alfa were taken in combination with the DAA.

CONCLUSIONS

This review demonstrates the strong evidence for the efficacy and safety of DAAs. The focus of HCV research should shift from efficacy of treatment to investigating accessible screening and diagnostics in order to achieve the World Health Organisation's (WHO's) goal of eradicating HCV by 2030.

摘要

背景与目的

丙型肝炎病毒(HCV)是中东地区主要的健康问题。直接作用抗病毒药物(DAA)的最新进展改变了HCV的治疗方式。所选用的DAA取决于导致感染的HCV基因型(GT)、肝硬化的存在情况以及既往治疗尝试。此外,人类免疫缺陷病毒(HIV)合并感染和肾功能损害等因素也会影响治疗。本综述旨在讨论和评估目前在中东地区获批用于丙型肝炎治疗的DAA的疗效和安全性证据。

方法

手动检索了英国国家卫生与临床优化研究所(NICE)和欧洲肝脏研究协会指南的支持性出版物。使用包括“HCV”“临床试验”以及NICE推荐的DAA组合的七种组合等检索词,对PubMed、MEDLINE、Cochrane图书馆和EMBASE数据库进行了文献检索。纳入了2016年1月至2021年1月期间的论文,以及该范围之外的重要论文。

关键内容与发现

在找到的390篇出版物中,纳入了62篇。在大多数研究中,DAA在推荐的GT、肝硬化状态和既往HCV治疗中显示出高疗效。DAA总体上被发现是安全且耐受性良好的:最常见的副作用是头痛和恶心。当利巴韦林和聚乙二醇干扰素α与DAA联合使用时会出现严重不良事件(SAE)。

结论

本综述证明了DAA疗效和安全性的有力证据。HCV研究的重点应从治疗疗效转向研究可及的筛查和诊断方法,以实现世界卫生组织(WHO)到2030年消除HCV的目标。

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本文引用的文献

1
Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection.《2023年丙型肝炎指南更新:美国肝病研究学会-美国感染病学会关于丙型肝炎病毒感染检测、管理及治疗的建议》
Clin Infect Dis. 2023 May 25. doi: 10.1093/cid/ciad319.
2
EASL recommendations on treatment of hepatitis C: Final update of the series.EASL 丙型肝炎治疗建议:系列的最终更新。
J Hepatol. 2020 Nov;73(5):1170-1218. doi: 10.1016/j.jhep.2020.08.018. Epub 2020 Sep 15.
3
Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2).
格卡瑞韦哌仑他韦治疗亚洲慢性丙型肝炎病毒感染:两项多中心、3 期研究-一项随机、双盲研究(VOYAGE-1)和一项开放标签、单臂研究(VOYAGE-2)。
Lancet Gastroenterol Hepatol. 2020 Sep;5(9):839-849. doi: 10.1016/S2468-1253(20)30086-8. Epub 2020 Jul 16.
4
Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study.索磷布韦联合利巴韦林和索磷布韦联合来迪派韦治疗基因型 1 或 3 丙型肝炎病毒合并严重肾功能损害患者:一项多中心、2b 期、非随机、开放标签研究。
Lancet Gastroenterol Hepatol. 2020 Oct;5(10):918-926. doi: 10.1016/S2468-1253(19)30417-0. Epub 2020 Jun 10.
5
Systematic review with meta-analysis: impact of baseline resistance-associated substitutions on the efficacy of glecaprevir/pibrentasvir among chronic hepatitis C patients.系统评价和荟萃分析:基线耐药相关突变对慢性丙型肝炎患者使用格卡瑞韦哌仑他韦治疗效果的影响。
Aliment Pharmacol Ther. 2020 Mar;51(5):490-504. doi: 10.1111/apt.15633. Epub 2020 Jan 14.
6
Sofosbuvir-containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment.含索磷布韦的治疗方案在治疗中度至重度肾功能损害的丙型肝炎病毒(HCV)患者时安全有效。
Liver Int. 2020 Apr;40(4):797-805. doi: 10.1111/liv.14299. Epub 2019 Dec 20.
7
Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection.glecaprevir/pibrentasvir治疗慢性丙型肝炎病毒感染的肾功能受损患者的疗效和安全性。
Liver Int. 2020 May;40(5):1032-1041. doi: 10.1111/liv.14320. Epub 2019 Dec 26.
8
Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial.格卡瑞韦/哌仑他韦治疗初治慢性 HCV 基因型 1-6 且代偿期肝硬化患者 8 周:EXPEDITION-8 试验。
J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.
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Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure.索磷布韦/维帕他韦/伏西瑞韦治疗既往 DAA 失败的丙型肝炎患者的真实世界疗效和安全性。
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