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索磷布韦-维帕他韦-利巴韦林方案对既往直接抗病毒药物治疗失败的慢性丙型肝炎患者再治疗的疗效:一项来自国家治疗中心的回顾性研究

Efficacy of Sofosbuvir-Velpatasvir-Ribavirin Regimen for Retreatment of Chronic Hepatitis C in Patients With Prior DAA Failure: A Retrospective Study From a National Treatment Center.

作者信息

Singh Sinku, Sengupta Sibangi, Kumar Deepak, Mukherjee Kousik, Hasan Abdulla M D, Sadhukhan Provash, Ahammed Sk Mahiuddin

机构信息

Department of Gastroenterology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.

Department of Hepatology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.

出版信息

Int J Hepatol. 2025 Sep 4;2025:9918357. doi: 10.1155/ijh/9918357. eCollection 2025.

Abstract

Direct-acting antivirals (DAAs) are highly effective in treating HCV infection, but a small subset of patients may fail to achieve SVR12 and require further intervention. In resource-limited settings where second-line DAAs (such as SOF/VEL/VOX) may be unavailable, optimizing first-line treatments is essential. This study evaluated the efficacy (SVR12) of a retreatment regimen based on first-line DAAs (SOF/VEL) with ribavirin. This retrospective study screened all viremic patients who attended the apex treatment center (ATC) between January 2019 and December 2023 and received DAAs as per the National Viral Hepatitis Control Program (NVHCP) guidelines. Patients who failed to achieve SVR12 were subsequently retreated with the available first-line regimen (SOF/VEL plus ribavirin). A total of 1814 viremic patients attended the ATC. One thousand two hundred and sixty-two patients completed therapy. One thousand one hundred ninety-eight (94.9%) patients achieved SVR12, and 64 patients (5.1%) failed to achieve SVR12. Additionally, 41 patients with DAA failure were referred from the treatment center (TC) and model treatment center (MTC) for evaluation. After further exclusions, 36 patients were enrolled, and 30 of them were offered retreatment. The majority of patients were male (64.5%) with a median age of 45 years (IQR, 19-68). Five patients were cirrhotic, while the remainder was noncirrhotic. Baseline HCV RNA levels before the retreatment regimen were 87,882 IU/mL (IQR, 9870-484,902). Most patients (96.6%) had Genotype 3 HCV infection. Prior to retreatment, 27 patients had received a 12-week regimen of sofosbuvir and daclatasvir, while only three had been treated with the sofosbuvir-velpatasvir regimen. After retreatment with sofosbuvir, velpatasvir, and ribavirin, 22 patients (73%) achieved SVR12. None of the patients experienced any adverse event. First-line DAAs are highly effective to treat naïve patients. In the absence of second-line options, retreatment with first-line DAAs (SOF/VEL plus ribavirin) is a viable alternative.

摘要

直接作用抗病毒药物(DAAs)在治疗丙型肝炎病毒(HCV)感染方面非常有效,但一小部分患者可能无法实现治疗12周后持续病毒学应答(SVR12),需要进一步干预。在资源有限的环境中,二线DAAs(如索磷布韦/维帕他韦/伏西瑞韦)可能无法获得,因此优化一线治疗至关重要。本研究评估了基于一线DAAs(索磷布韦/维帕他韦)联合利巴韦林的再治疗方案的疗效(SVR12)。这项回顾性研究筛查了2019年1月至2023年12月期间在顶级治疗中心(ATC)就诊并按照国家病毒性肝炎控制项目(NVHCP)指南接受DAAs治疗的所有病毒血症患者。未实现SVR12的患者随后接受可用的一线方案(索磷布韦/维帕他韦加利巴韦林)再治疗。共有1814名病毒血症患者在ATC就诊。1262名患者完成了治疗。1198名(94.9%)患者实现了SVR12,64名(5.1%)患者未实现SVR12。此外,41名DAAs治疗失败的患者从治疗中心(TC)和示范治疗中心(MTC)转诊来进行评估。经过进一步排除,36名患者被纳入研究,其中30名患者接受了再治疗。大多数患者为男性(64.5%),中位年龄为45岁(四分位间距,19 - 68岁)。5名患者为肝硬化患者,其余为非肝硬化患者。再治疗方案前的基线HCV RNA水平为87,882 IU/mL(四分位间距,9870 - 484,902)。大多数患者(96.6%)感染的是3型HCV。再治疗前,27名患者接受了12周的索磷布韦和达卡他韦治疗方案,而只有3名患者接受过索磷布韦 - 维帕他韦治疗方案。在接受索磷布韦、维帕他韦和利巴韦林再治疗后,22名患者(73%)实现了SVR12。没有患者出现任何不良事件。一线DAAs对初治患者非常有效。在没有二线治疗方案的情况下,用一线DAAs(索磷布韦/维帕他韦加利巴韦林)进行再治疗是一种可行的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fc1/12425630/c0e3842f9775/IJH2025-9918357.001.jpg

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