Sofosbuvir-based antiviral therapy in hepatitis C virus patients with severe renal failure
Sofosbuvir-based antiviral therapy in hepatitis C virus patients with severe renal failure
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DOI：
10.1093/ndt/gfw348
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发表时间：
2017-12-01
影响因子：
6.1
通讯作者：
Leroy, Vincent
中科院分区：
文献类型：
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作者：
Dumortier, Jerome;Bailly, Francois;Leroy, Vincent
背景。慢性丙型肝炎病毒（HCV）感染是终末期肾病（ESRD）患者最常见的慢性肝病。在过去的几年里，第二代直接作用抗病毒药物在丙型肝炎的治疗中发生了革命性的变化，而索非布韦 (SOF) 是大多数现代治疗策略的支柱。由于SOF通过肾脏消除，这项多中心回顾性研究的目的是评估其对患有严重肾功能衰竭的HCV感染患者[包括血液透析(HD)患者]的抗病毒功效和安全性。方法。 50 名患有慢性 HCV 感染（G1：28/56%，肝硬化：27/54%）和严重肾功能衰竭的患者（36 名男性，平均年龄 6 标准差 60.56 ± 7.5 岁）[即MDRD 估计肾小球滤过率 (eGFR) < 35 mL/min]，包括 35 名接受 HD 的患者入组。抗病毒治疗包括 SOF/利巴韦林 (RBV) (n = 7)、SOF/RBV/聚乙二醇化干扰素 (n = 2)、SOF/daclatasvir 6 RBV (n = 30) 或 SOF/simeprevir6 RBV (n = 11)，疗程为 12 或 24 周。所有 HD 患者均给予减少剂量的 SOF（每周 3 次 400 毫克或每隔一天 400 毫克）。 RBV 的初始剂量 (n = 12) 范围为 400 至 4200 毫克/周。结果。根据基于意向治疗的分析，12 周时持续病毒学缓解率为 86%。治疗期间，接受 RBV 治疗的患者血红蛋白水平没有显着改变，但重组促红细胞生成素 (rEPO) 剂量显着增加。两名患者（4%）需要输血。没有患者因副作用而停止治疗。两名患者 (16.7%) 在抗病毒治疗期间减少了 RBV 剂量。由于副作用，两名非 HD 患者的 SOF 剂量减少。在非 HD 患者中，治疗期间中位 eGFR 没有显着改变。结论。我们的结果强烈表明，基于 SOF 的抗病毒治疗（减少 SOF 剂量）对于治疗伴有 ESRD 的 HCV 患者（包括 HD 患者）是安全有效的。
Background. Chronic hepatitis C virus (HCV) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD). Over the last few years, secondgeneration direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies. Since SOF is eliminated through the kidney, the aim of this multicentre retrospective study was to assess its antiviral efficacy and safety in HCVinfected patients with severe renal failure [including haemodialysis (HD) patients].Methods. Fifty patients (36 males, mean age 6 standard deviation 60.56 7.5 years) with chronic HCV infection (G1: 28/56%, cirrhosis: 27/54%) and severe renal failure [i.e. MDRD estimated glomerular filtration rate (eGFR) < 35 mL/min], including 35 on HD, were enrolled. Antiviral treatment consisted of SOF/ribavirin (RBV) (n = 7), SOF/RBV/pegylated interferon (n = 2), SOF/daclatasvir 6 RBV (n = 30) or SOF/simeprevir6 RBV (n = 11) for 12 or 24 weeks. A reduced dose of SOF (400 mg three times a week or 400 mg every other day) was given to all HD patients. Initial dose of RBV (n = 12) ranged from 400 to 4200 mg/week.Results. On an intent-to-treat-based analysis, sustained virological response rate was 86% at 12 weeks. During therapy, haemoglobin levels were not significantly modified, but recombinant erythropoietin (rEPO) dose significantly increased in patients treated with RBV. Two patients (4%) required blood transfusion. No patient had treatment discontinuation due to side effects. Dose of RBV was reduced in two patients (16.7%) during antiviral therapy. Dose of SOF was reduced in two non-HD patients because of side effects. In non-HD patients, median eGFR was not significantly modified during treatment.Conclusions. Our results strongly suggest that SOF-based antiviral therapy, with a reduced dose of SOF, is safe and effective for the treatment of HCV patients with ESRD, including HD patients.