Background Given the high mortality rate for patients with end-stage kidney disease receiving dialysis and the efficacy and safety of hepatitis C virus (HCV) treatments, discarded kidneys from HCV-infected donors may be a neglected public health resource. Objective To determine the tolerability and feasibility of using direct-acting antivirals (DAAs) as prophylaxis before and after kidney transplantation from HCV-infected donors to non-HCV-infected recipients (that is, HCV D+/R- transplantation). Design Open-label nonrandomized trial. (ClinicalTrials.gov: NCT02781649). Setting Single center. Participants 10 HCV D+/R- kidney transplant candidates older than 50 years with no available living donors. Intervention Transplantation of kidneys from deceased donors aged 13 to 50 years with positive HCV RNA and HCV antibody test results. All recipients received a dose of grazoprevir (GZR), 100 mg, and elbasvir (EBR), 50 mg, immediately before transplantation. Recipients of kidneys from donors with genotype 1 infection continued receiving GZR-EBR for 12 weeks after transplantation; those receiving organs from donors with genotype 2 or 3 infection had sofosbuvir, 400 mg, added to GZR-EBR for 12 weeks of triple therapy. Measurements The primary safety outcome was the incidence of adverse events related to GZR-EBR treatment. The primary efficacy outcome was the proportion of recipients with an HCV RNA level below the lower limit of quantification 12 weeks after prophylaxis. Results Among 10 HCV D+/R- transplant recipients, no treatment-related adverse events occurred, and HCV RNA was not detected in any recipient 12 weeks after treatment. Limitation Nonrandomized study design and a small number of patients. Conclusion Pre- and posttransplantation HCV treatment was safe and prevented chronic HCV infection in HCV D+/R- kidney transplant recipients. If confirmed in larger studies, this strategy should markedly expand organ options and reduce mortality for kidney transplant candidates without HCV infection. Primary Funding Source Merck Sharp & Dohme.

中文翻译：

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从丙型肝炎病毒感染的供体到未感染的受者的肾移植中的直接抗病毒预防：一项开放标签的非随机试验。

背景 鉴于接受透析的终末期肾病患者的高死亡率以及丙型肝炎病毒 (HCV) 治疗的有效性和安全性，来自 HCV 感染供体的废弃肾脏可能是一种被忽视的公共卫生资源。目的 确定 HCV 感染供体向非 HCV 感染受者（即 HCV D+/R- 移植）肾移植前后使用直接抗病毒药物（DAA）预防的耐受性和可行性。设计开放标签非随机试验。（ClinicalTrials.gov：NCT02781649）。设置单中心。参与者 10 名 50 岁以上且无可用活体供体的 HCV D+/R- 肾移植候选者。干预 HCV RNA 和 HCV 抗体检测结果为阳性的 13 至 50 岁已故捐献者的肾脏移植。所有接受者在移植前立即接受了 100 mg grazoprevir (GZR) 和 50 mg elbasvir (EBR) 的剂量。来自基因型 1 感染供体的肾脏接受者在移植后继续接受 GZR-EBR 12 周；那些接受基因型 2 或 3 感染供体器官的患者在 GZR-EBR 中添加了 400 毫克索非布韦，进行为期 12 周的三联疗法。测量 主要安全性结果是与 GZR-EBR 治疗相关的不良事件的发生率。主要疗效结果是预防后 12 周 HCV RNA 水平低于量化下限的受者比例。结果 10 例 HCV D+/R- 移植受者中，均未发生治疗相关的不良事件，治疗后 12 周均未检测到任何受者的 HCV RNA。局限性 非随机研究设计和少数患者。结论 HCV D+/R-肾移植受者在移植前和移植后进行 HCV 治疗是安全的，可预防慢性 HCV 感染。如果在更大规模的研究中得到证实，该策略应显着扩大器官选择并降低未感染 HCV 的肾移植候选者的死亡率。主要资金来源 Merck Sharp & Dohme。