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接受索磷布韦/维帕他韦/伏西瑞韦治疗的慢性丙型肝炎患者的治疗反应评估:来自土耳其的多中心真实世界经验。

Evaluation of Treatment Response in Chronic Hepatitis C Patients Receiving Sofosbuvir/Velpatasvir/Voxilaprevir: A Multicenter Real-World Experience from Türkiye.

作者信息

Binay Umut Devrim, Karakeçili Faruk, Aygen Bilgehan, Kılınç Toker Ayşin, Çelik İlhami, Demirtürk Neşe, Şimşek Bozok Tuğçe, Dursun Leyla, Akgül Fethiye, Çınar Güle, Günal Özgür, Asan Ali, Arslan Eyüp, Yılmaz Karadağ Fatma, Barkay Orçun, Akdemir İrem, Şimşek Funda, Türkoğlu Yılmaz Emine, Eğilmez Zeynep Ravza, Tekin Süda

机构信息

Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Erzincan Binali Yıldırım University, 24100 Erzincan, Türkiye.

Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Erciyes University, 38030 Kayseri, Türkiye.

出版信息

Viruses. 2025 Jun 30;17(7):931. doi: 10.3390/v17070931.

Abstract

The combination of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) is recommended as a salvage therapy for treatment-experienced chronic hepatitis C (CHC) patients. However, it is used in our country for treatment-naïve and treatment-experienced patients. This study aims to present real-world data from Türkiye on CHC patients treated with SOF/VEL/VOX. The present study was conducted by the Viral Hepatitis Study Group of the Turkish Society of Clinical Microbiology and Infectious Diseases (KLİMİK). It was a multicenter, retrospective, observational study. The data were collected from patients receiving SOF/VEL/VOX therapy at 12 medical centers in Türkiye between 1 June 2022 and 31 December 2024. The patients had received the treatment for 8 to 12 weeks. Of the 139 patients enrolled, 63.3% ( = 88) were male, with a mean age of 54.4 years. Most patients were non-cirrhotic (94.2%, = 131) and treatment-naïve (92%, = 128); 49.6% ( = 69) were infected with genotype 1b. Early virologic response (EVR) could be assessed in 126 patients, with an EVR rate of 82.5% ( = 104). End-of-treatment data were available for 113 patients, all achieving an end-of-treatment response. Among the 80 patients for whom week-12 post-treatment data were available, 97.5% sustained virologic response at week 12 (SVR12). Significant improvements were observed in AST, ALT, and platelet levels, along with reductions in APRI and FIB-4 scores ( = 0.001)." No serious adverse events leading to treatment discontinuation were reported. Mild adverse events included pruritus (2.1%, = 3), fatigue (2.1%, = 3), and nausea (1.4%, = 2). The SOF/VEL/VOX combination is a highly effective and well-tolerated treatment option in treatment-naïve CHC patients, achieving an SVR12 rate of 97.5%.

摘要

索磷布韦/维帕他韦/伏西瑞韦(SOF/VEL/VOX)联合用药被推荐作为治疗经验丰富的慢性丙型肝炎(CHC)患者的挽救疗法。然而,在我国它也用于初治和治疗经验丰富的患者。本研究旨在展示来自土耳其的关于接受SOF/VEL/VOX治疗的CHC患者的真实世界数据。本研究由土耳其临床微生物学和传染病学会(KLİMİK)的病毒性肝炎研究小组开展。这是一项多中心、回顾性、观察性研究。数据收集自2022年6月1日至2024年12月31日期间在土耳其12个医疗中心接受SOF/VEL/VOX治疗的患者。这些患者接受了8至12周的治疗。在纳入的139例患者中,63.3%(n = 88)为男性,平均年龄54.4岁。大多数患者无肝硬化(94.2%,n = 131)且为初治患者(92%,n = 128);49.6%(n = 69)感染基因1b型。126例患者可评估早期病毒学应答(EVR),EVR率为82.5%(n = 104)。113例患者有治疗结束时的数据,所有患者均实现治疗结束时应答。在有治疗后第12周数据的80例患者中,97.5%在第12周实现持续病毒学应答(SVR12)。观察到天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)和血小板水平有显著改善,同时天冬氨酸氨基转移酶与血小板比值指数(APRI)和FIB - 4评分降低(P = 0.001)。未报告导致治疗中断的严重不良事件。轻度不良事件包括瘙痒(2.1%,n = 3)、疲劳(2.1%,n = 3)和恶心(1.4%,n = 2)。SOF/VEL/VOX联合用药在初治CHC患者中是一种高效且耐受性良好的治疗选择,SVR12率达97.5%。

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