Digestive Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
PLoS One. 2021 Feb 10;16(2):e0246594. doi: 10.1371/journal.pone.0246594. eCollection 2021.
Sofosbuvir seems to be a revolutionary treatment for Hepatitis C-infected patients with advanced chronic kidney disease (CKD) but existing evidence is not quite adequate. The aim of this study was to evaluate the efficacy and safety of Sofosbuvir-based therapy without Ribavirin for all hepatitis C virus genotypes among patients with advanced CKD. We conducted an updated systematic literature search from the beginning of 2013 up to June 2020. Sustained virologic response (SVR) rate at 12 and/or 24 weeks after the end of treatment, and adverse events in HCV-infected patients with advanced CKD were pooled using random effects models. We included 27 published articles in our meta-analyses, totaling 1,464 HCV-infected patients with advanced CKD. We found a substantial heterogeneity based on the I2 index (P = 0.00, I2 = 56.1%). The pooled SVR rates at 12 and 24 weeks after the end of Sofosbuvir-based treatment were 97% (95% Confidence Interval: 95-99) and 95% (89-99) respectively. The pooled SVR12 rates were 98% (96-100) and 94% (90-97) in patients under 60 and over 60 years old respectively. The pooled incidence of severe adverse events was 0.11 (0.04-0.19). The pooled SVR12 rate after completion of the half dose regimen was as high as the full dose treatment but it was associated with less adverse events (0.06 versus 0.14). The pooled SVR12 rate was 98% (91-100) in cirrhotic patients and 100% (98-100) in non-cirrhotic patients. The endorsement of Sofosbuvir-based regimen can improve the treatment of hepatitis C virus infection in patients with advanced CKD.
索非布韦似乎是一种治疗晚期慢性肾脏病（CKD）合并丙型肝炎病毒（HCV）感染患者的革命性疗法，但现有证据尚不够充分。本研究旨在评估无利巴韦林的索非布韦方案治疗所有基因型 HCV 感染合并晚期 CKD 患者的疗效和安全性。我们从 2013 年初至 2020 年 6 月进行了更新的系统文献检索。采用随机效应模型汇总治疗结束后 12 周和/或 24 周时的持续病毒学应答（SVR）率和 HCV 感染合并晚期 CKD 患者的不良事件。我们将 27 篇已发表的文章纳入荟萃分析，共纳入 1464 例 HCV 感染合并晚期 CKD 患者。根据 I2 指数（P = 0.00，I2 = 56.1%），我们发现存在显著异质性。基于索非布韦治疗结束后 12 周和 24 周时的 SVR 率分别为 97%（95%置信区间：95-99）和 95%（89-99）。60 岁以下和 60 岁以上患者的 SVR12 率分别为 98%（96-100）和 94%（90-97）。严重不良事件的汇总发生率为 0.11（0.04-0.19）。半剂量方案完成后的 SVR12 率与全剂量治疗相当，但不良反应较少（0.06 比 0.14）。肝硬化患者的 SVR12 率为 98%（91-100），非肝硬化患者为 100%（98-100）。推荐使用索非布韦方案可以改善晚期 CKD 合并 HCV 感染患者的治疗效果。
