Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Nephrology (Carlton). 2022 Jan;27(1):82-89. doi: 10.1111/nep.13968. Epub 2021 Sep 14.
Sofosbuvir (SOF) and velpatasvir (VEL) is a pan-genotypic regimen for the treatment of Hepatitis C virus (HCV) infection. The data on the efficacy and safety of this regimen is end-stage renal disease (ESRD) is scanty. This systematic review and meta-analysis was done to ascertain the efficacy and safety of SOF and VEL in patients with chronic Hepatitis C (CHC) and ESRD on renal replacement therapy (RRT).
Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals). Pooled sustained virologic response (SVR) and adverse event rates with 95% confidence intervals were estimated.
Seven studies (410 patients with CHC and ESRD on RRT) fulfilled our eligibility criteria. The overall pooled SVR rate of SOF and VEL in patients with HCV on RRT was 97.69% (95% CI: 95.71 to 98.92). There was no significant heterogeneity (I : 39.3%, p-value of Cochran's Q = 0.13) among the studies. The pooled estimate of efficacy of SOF-VEL combination among patients with cirrhosis was 91.94% (95% CI 77.03-98.52). Pooled SVR rates in genotype 3 infection [94.6%, (95%: CI 81.3-99.4)] was comparable to that in those with documented non-genotype 3 infection [94.63%, (95% CI 87.12-98.44)]. No serious adverse event attributable to SOF and VEL was reported in the included studies.
The fixed-dose combination of SOF and VEL is effective and safe in CHC patients with ESRD on RRT.
索磷布韦(SOF)和维帕他韦(VEL)是一种针对丙型肝炎病毒(HCV)感染的泛基因型治疗方案。关于该方案在终末期肾病(ESRD)患者中的疗效和安全性的数据很少。本系统评价和荟萃分析旨在确定 SOF 和 VEL 在接受肾脏替代治疗(RRT)的慢性丙型肝炎(CHC)和 ESRD 患者中的疗效和安全性。
使用搜索词(终末期肾病或肾脏替代治疗或慢性肾衰竭或严重肾功能不全或慢性肾病或血液透析或透析或腹膜透析)和(索磷布韦或维帕他韦或 NS5A 抑制剂或直接作用抗病毒药物)对 Pubmed、Embase、Scopus 和 Google Scholar 进行系统搜索。使用 95%置信区间估计合并持续病毒学应答(SVR)和不良事件发生率。
有 7 项研究(410 名接受 RRT 的 CHC 和 ESRD 患者)符合我们的入选标准。在接受 RRT 的 HCV 患者中,SOF 和 VEL 的总体 SVR 率为 97.69%(95%CI:95.71-98.92)。研究之间没有显著的异质性(I:39.3%,Cochran's Q 值的 p 值为 0.13)。SOF-VEL 联合治疗肝硬化患者的疗效估计值为 91.94%(95%CI 77.03-98.52)。基因型 3 感染患者的 SVR 率[94.6%,(95%:CI 81.3-99.4)]与已确诊的非基因型 3 感染患者相似[94.63%,(95% CI 87.12-98.44)]。在纳入的研究中,没有报告归因于 SOF 和 VEL 的严重不良事件。
SOF 和 VEL 的固定剂量联合方案在接受 RRT 的 CHC 合并 ESRD 患者中是有效且安全的。