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接受直接抗病毒药物治疗后获得持续病毒学应答的慢性丙型肝炎患者的长期临床结局:一项长达十年的前瞻性研究。

Long Term Clinical Outcomes in Chronic Hepatitis C Patients Who Achieved SVR Following DAAs: A Decade Long Prospective Study.

作者信息

Shiha Gamal, Helmy Ahmed, Mikhail Nabiel, Hassan Ayman, Elkerdawy Heidi, Badawy Ghada, El Maghrabi Hanzada, El-Domiaty Nada, Soliman Riham

机构信息

Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.

Gastroenterology and Hepatology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

J Viral Hepat. 2025 Jul;32(7):e70044. doi: 10.1111/jvh.70044.

DOI:10.1111/jvh.70044
PMID:40511633
Abstract

The long-term impact of direct-acting antivirals (DAAs) in chronic hepatitis C virus (HCV) patients remains debated. This study evaluates all-cause mortality, hepatocellular carcinoma (HCC), and decompensated cirrhosis in DAAs-treated patients enrolled in the 'Educate, Test, and Treat' programme. This prospective observational study included HCV patients treated at the Egyptian Liver Research Institute and Hospital (ELRIAH) from 2015 to 2018. Participants were recruited from 12 villages and followed until the end of 2024. Exclusions included decompensated liver disease, hepatitis B virus (HBV)/human immunodeficiency virus (HIV) co-infection, prior HCC, or severe comorbidities. Follow-up included clinical, biochemical, ultrasound, and liver stiffness measurements (LSM). Primary outcomes were all-cause mortality, HCC, and decompensated cirrhosis. Kaplan-Meier curves and Cox models analyse data. Of 3328 eligible patients, follow-up data were available for 3017 (53% male, mean follow-up: 84.5 ± 28.9 months). Advanced fibrosis (F3-F4) was present in 1125 (37.3%). The study recorded 593 deaths (2.58/100 person-years), 271 HCC cases (1.24/100 person-years), and 281 decompensated cirrhosis cases (1.30/100 person-years). Advanced fibrosis was associated with increased mortality (HR: 1.72, 95% CI: 1.46-2.03, p < 0.001) and decompensation (HR: 2.23, 95% CI: 1.74-2.85, p < 0.001) but not HCC (HR: 1.17, 95% CI: 0.92-1.49, p = 0.192). Fibrosis reversed in 11.9%, improved in 17.8%, remained stable in 50.5%, and progressed in 19.8%. This decade-long study confirms DAAs improve liver function, reduce mortality, and slow disease progression, reinforcing their role in preventing long-term complications.

摘要

直接作用抗病毒药物(DAAs)对慢性丙型肝炎病毒(HCV)患者的长期影响仍存在争议。本研究评估了参与“教育、检测与治疗”项目的接受DAAs治疗患者的全因死亡率、肝细胞癌(HCC)和失代偿期肝硬化情况。这项前瞻性观察性研究纳入了2015年至2018年在埃及肝脏研究机构与医院(ELRIAH)接受治疗的HCV患者。参与者来自12个村庄,并随访至2024年底。排除标准包括失代偿期肝病、乙型肝炎病毒(HBV)/人类免疫缺陷病毒(HIV)合并感染、既往HCC或严重合并症。随访内容包括临床、生化、超声和肝脏硬度测量(LSM)。主要结局为全因死亡率、HCC和失代偿期肝硬化。采用Kaplan-Meier曲线和Cox模型分析数据。在3328例符合条件的患者中,有3017例(53%为男性,平均随访时间:84.5±28.9个月)可获得随访数据。1125例(37.3%)存在高级纤维化(F3-F4)。该研究记录了593例死亡(2.58/100人年)、271例HCC病例(1.24/100人年)和281例失代偿期肝硬化病例(1.30/100人年)。高级纤维化与死亡率增加(HR:1.72,95%CI:1.46-2.03,p<0.001)和失代偿(HR:2.23,95%CI:1.74-2.85,p<0.001)相关,但与HCC无关(HR:1.17,95%CI:0.92-1.49,p=0.192)。纤维化逆转的比例为11.9%,改善的比例为17.8%,保持稳定的比例为50.5%,进展的比例为19.8%。这项长达十年的研究证实,DAAs可改善肝功能、降低死亡率并减缓疾病进展,强化了其在预防长期并发症方面的作用。

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