索非布韦和维帕他韦固定剂量复方制剂对伴有终末期肾病的慢性丙型肝炎患者安全有效

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY Journal of Clinical and Experimental Hepatology Pub Date : 2024-02-29 DOI:10.1016/j.jceh.2024.101367

Manas K. Behera , Prabir Majji , Sanatan Behera , Manoj Pani , Arupam Mohapatro , Umesh C. Patra , Susanta K. Jena

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引用次数: 0

摘要

背景在印度，丙型肝炎病毒（HCV）的负担令人担忧，其中终末期肾病（ESRD）患者占很大比例。索非布韦和维帕他韦的泛基因型联合用药在我国这样资源紧张的国家被认为是安全、有效和经济的。然而，关于索非布韦和 velpatasvir 联合疗法在 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，以评估索非布韦和 velpatasvir 联合用药在患有 ESRD 的慢性丙型肝炎（CHC）患者中的安全性和有效性。所有患者都接受了索非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的疗程为12周，失代偿期肝硬化患者的疗程为24周。疗效通过治疗后 12 周 HCV RNA 阴性（持续病毒学应答 [SVR] 12）的持续病毒学应答进行评估，安全性通过记录所有患者的任何副作用进行评估。平均年龄为（49.87 ± 12.13）岁，80%的患者为男性。平均基线 HCV RNA 为 2.61 ± 7.83 × 106 IU/ml。所有 40 名患者（100%）在治疗结束时均检测不到 HCV RNA；然而，39 名患者（97.5%）获得了 SVR 12。与基线 eGFR（13.27 ± 10.32 vs 13.54 ± 11.38，P = 0.54）相比，抗病毒治疗结束后估计肾小球滤过率（eGFR）没有明显恶化。结论索非布韦和维帕他韦的固定剂量联合用药对患有 ESRD 的 CHC 患者有效，且具有良好的安全性。

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The Fixed Dose Combination of Sofosbuvir and Velpatasvir is Safe and Effective in Patients of Chronic Hepatitis C With End-stage Renal Disease

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 × 10⁶ 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, P = 0.54). None of the patients reported any serious adverse effects during treatment.