索磷布韦与维帕他韦的固定剂量组合对终末期肾病的慢性丙型肝炎患者安全有效。
The Fixed Dose Combination of Sofosbuvir and Velpatasvir is Safe and Effective in Patients of Chronic Hepatitis C With End-stage Renal Disease.
作者信息
Behera Manas K, Majji Prabir, Behera Sanatan, Pani Manoj, Mohapatro Arupam, Patra Umesh C, Jena Susanta K
机构信息
Department of Hepatology, SCB Medical College and Hospital, Cuttack, India.
NVHCP, SCB Medical College and Hospital, Cuttack, India.
出版信息
J Clin Exp Hepatol. 2024 Jul-Aug;14(4):101367. doi: 10.1016/j.jceh.2024.101367. Epub 2024 Feb 29.
BACKGROUND
The burden of hepatitis C virus (HCV) in India is alarming, with a major share of this virus being witnessed in patients with end-stage renal disease (ESRD). A pan-genotypic combination of sofosbuvir and velpatasvir is found to be safe, effective, and economical in resource-constraint countries such as ours. However, there are scanty data on the efficacy and safety of sofosbuvir and velpatasvir combination in patients with ESRD. Hence, we performed this study to evaluate the safety and efficacy of the combination of sofosbuvir and velpatasvir in patients of chronic hepatitis C (CHC) with ESRD.
METHODS
This is an observational study comprising of 40 CHC patients with ESRD on maintenance hemodialysis. All patients were treated with a fixed-dose combination of sofosbuvir and velpatasvir for 12 weeks in case of non-cirrhotic or compensated cirrhosis and 24 weeks in case of decompensated cirrhosis. The efficacy was assessed by sustained virological response defined by negative HCV RNA at 12 weeks (sustained virological response [SVR] 12) post treatment, and safety was assessed by recording any side-effects of all patients.
RESULTS
Out of the 40 patients enrolled in our study, majority were non-cirrhotic (77%), and all were treatment-naive. The mean age was 49.87 ± 12.13 years, and 80% patients were male. The mean baseline HCV RNA was 2.61 ± 7.83 × 10 IU/ml. All the 40 patients (100%) achieved undetectable HCV RNA at the end of treatment; however, 39 patients (97.5%) achieved SVR 12. There was no significant deterioration of estimated glomerular filtration rate (eGFR) after completion of antiviral therapy as compared to the baseline eGFR (13.27 ± 10.32 vs13.54 ± 11.38, = 0.54). None of the patients reported any serious adverse effects during treatment.
CONCLUSION
The fixed-dose combination of sofosbuvir and velpatasvir is effective and has showed excellent safety profile in patients of CHC with ESRD.
背景
印度丙型肝炎病毒（HCV）负担惊人，在终末期肾病（ESRD）患者中该病毒感染占很大比例。在我们这样资源有限的国家，索磷布韦和维帕他韦的泛基因型联合用药已被证明是安全、有效且经济的。然而，关于索磷布韦和维帕他韦联合用药在ESRD患者中的疗效和安全性的数据却很少。因此，我们开展了这项研究，以评估索磷布韦和维帕他韦联合用药对慢性丙型肝炎（CHC）合并ESRD患者的安全性和疗效。
方法
这是一项观察性研究，纳入了40例接受维持性血液透析的CHC合并ESRD患者。所有患者均接受索磷布韦和维帕他韦的固定剂量联合治疗，非肝硬化或代偿期肝硬化患者治疗12周，失代偿期肝硬化患者治疗24周。疗效通过治疗后12周时HCV RNA阴性定义的持续病毒学应答（SVR）来评估，安全性通过记录所有患者的任何副作用来评估。
结果
在我们研究纳入的40例患者中，大多数为非肝硬化患者（77%），且均为初治患者。平均年龄为49.87±12.13岁，80%的患者为男性。基线时HCV RNA的平均值为2.61±7.83×10 IU/ml。所有40例患者（100%）在治疗结束时HCV RNA检测不到；然而，39例患者（97.5%）实现了SVR 12。与基线估计肾小球滤过率（eGFR）相比，抗病毒治疗完成后eGFR无显著恶化（13.27±10.32 vs 13.54±11.38，P = 0.54）。治疗期间没有患者报告任何严重不良反应。
结论
索磷布韦和维帕他韦的固定剂量联合用药对CHC合并ESRD患者有效，且显示出良好的安全性。
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