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阿曼直接作用抗病毒药物治疗丙型肝炎的真实世界经验、有效性和安全性:一项横断面多中心研究

Real-World Experience, Effectiveness, and Safety of Direct-Acting Antivirals for the Treatment of Hepatitis C in Oman: A Cross-Sectional, Multicenter Study.

作者信息

Al-Naamani Khalid M, Omar Heba, Al Busafi Said A, Al Shuaili Halima H, Al-Naamani Zakariya, Al-Khabori Murtadha, Said Elias A, AlKalbani Abdullah H, Kamath B R, Emad Bashar, Daar Shahina, Alhajri Lolo, AlKalbani Alya, AlFarsi Zainab, Alzuhaibi Haifa

机构信息

Department of Internal Medicine, Division of Gastroenterology & Hepatology, The Medical City of Military and Security Services, Muscat 111, Oman.

Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo 11652, Egypt.

出版信息

J Clin Med. 2024 Dec 5;13(23):7411. doi: 10.3390/jcm13237411.

Abstract

: The advent of direct-acting antiviral (DAA) therapy has revolutionized the treatment landscape of the hepatitis C virus (HCV) infection. This study aimed to provide a comprehensive research study of the real-world effectiveness and safety of DAA treatment, representing the first study conducted in the Omani population. : A cross-sectional study was conducted including 375 HCV patients with different genotypes, treated using different DAA regimens, with or without ribavirin, between January 2012 and December 2020 at the Sultan Qaboos University Hospital and the medical city for military and security services, two tertiary hospitals in Muscat, Oman. The rate of sustained virologic response 12 weeks after completing the regimen (SVR-12) was analyzed as the primary outcome. Secondary outcomes included treatment safety and adverse events related to DAA therapy, as reported by patients and treating physicians. : A total of 375 patients were included in the study, with a mean age of 47.3 ± 15.4 years. Most were male (59.2%) and treatment-naïve (71.7%). The prevalence of liver cirrhosis was 19.7%, while 4.0% had hepatocellular carcinoma (HCC). The SVR-12 rate among treatment-naïve and treatment-experienced patients was 95.0% and 93.4%, respectively. Several parameters were associated with DAA treatment failure, including liver cirrhosis ( = 0.004) and active HCC ( = 0.009). Following SVR-12, significant improvements were observed in alanine transaminase, bilirubin, and albumin levels, Fibrosis-4 Index, and liver stiffness measurements compared to baseline ( <0.001 each). No significant adverse effects were reported. : Based on our real-world experience, DAAs are highly effective in treating patients with HCV infection in Oman, with an excellent tolerability and safety profile.

摘要

直接作用抗病毒药物(DAA)疗法的出现彻底改变了丙型肝炎病毒(HCV)感染的治疗格局。本研究旨在对DAA治疗的真实疗效和安全性进行全面的研究,这是在阿曼人群中开展的第一项此类研究。

开展了一项横断面研究,纳入了2012年1月至2020年12月期间在阿曼马斯喀特的两家三级医院——苏丹卡布斯大学医院以及军事和安全服务医疗城接受治疗的375例不同基因型的HCV患者,这些患者使用了不同的DAA方案,有或没有联合利巴韦林。将完成治疗方案12周后的持续病毒学应答率(SVR-12)作为主要结局进行分析。次要结局包括患者和治疗医生报告的与DAA治疗相关的治疗安全性和不良事件。

该研究共纳入375例患者,平均年龄为47.3±15.4岁。大多数为男性(59.2%)且既往未接受过治疗(71.7%)。肝硬化患病率为19.7%,而肝细胞癌(HCC)患病率为4.0%。既往未接受过治疗和接受过治疗的患者的SVR-12率分别为95.0%和93.4%。有几个参数与DAA治疗失败相关,包括肝硬化(P = 0.004)和活动性HCC(P = 0.009)。与基线相比,SVR-12后丙氨酸转氨酶、胆红素和白蛋白水平、Fibrosis-4指数以及肝脏硬度测量值均有显著改善(各项P均<0.001)。未报告显著的不良反应。

基于我们的真实世界经验,DAA在治疗阿曼的HCV感染患者方面非常有效,具有良好的耐受性和安全性。

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