Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients A Single-Group Trial
Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients A Single-Group Trial
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DOI：
10.7326/m18-0749
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发表时间：
2018-09-04
影响因子：
39.2
通讯作者：
Goldberg, David S.
中科院分区：
文献类型：
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作者：
Reese, Peter P.;Abt, Peter L.;Goldberg, David S.
背景：来自感染丙型肝炎病毒（HCV）的已故捐献者的器官经常被丢弃。包括 THINKER-1（将丙型肝炎肾脏移植到阴性肾脏受体中）在内的两项小型试验的初步数据表明，HCV 感染的肾脏可以安全地移植到 HCV 阴性患者体内。然而，需要生活质量和肾功能的中期数据来为患者提供有关风险的咨询。 目的：描述 THINKER-1 中 10 名肾脏接受者的 12 个月 HCV 治疗结果、估计肾小球滤过率 (eGFR) 和生活质量以及另外 10 名接受者的 6 个月数据。 设计：开放标签、非随机试验。 （ClinicalTrials.gov：NCT02743897）地点：单中心。参与者：20 名 HCV 阴性移植候选者。干预：参与者接受感染基因型 1 HCV 的肾脏移植，并在移植后第 3 天接受艾尔巴韦-格拉佐瑞韦治疗。测量：主要结果是 HCV 治愈。探索性结果包括 1) 入组时和移植后的 RAND-36 身体成分总结 (PCS) 和精神成分总结 (MCS) 生活质量评分，以及 2) 移植后肾功能，以 1:5 匹配的样本与 HCV 阴性肾脏受者进行比较。 结果：THINKER 参与者的平均年龄为 56.3 岁（SD，6.7），70% 为男性，40% 为男性黑色。所有 20 名参与者均实现了 HCV 治愈。肝脏和肾脏并发症是暂时的或已得到成功控制。平均 PCS 和 MCS 生活质量评分在 4 周时下降；随后 PCS 评分增加至移植前值以上，而 MCS 评分则恢复至基线值。 THINKER 参与者和匹配的 HCV 阴性肾脏受者在 6 个月时（中位数为 67.5 vs. 66.2 mL/min/1.73m(2)；组间差异 95% CI，-4.2 至 7.5 mL/min/1.73m(2)）和 12 个月时（中位数为 72.8 vs. 67.2）估计 GFR 相似mL/min/1.73m(2)；组间差异 CI，-7.2 至 9.8 mL/min/1.73m(2))。局限性：小规模试验。结论：HCV 感染肾脏的 20 名 HCV 阴性受者经历了 HCV 治愈、良好的生活质量和良好的肾功能。来自感染 HCV 的捐献者的肾脏可能是一种宝贵的移植资源。
Background: Organs from hepatitis C virus (HCV)-infected deceased donors are often discarded. Preliminary data from 2 small trials, including THINKER-1 (Transplanting Hepatitis C kidneys Into Negative KidnEy Recipients), suggested that HCV-infected kidneys could be safely transplanted into HCV-negative patients. However, intermediate-term data on quality of life and renal function are needed to counsel patients about risk.Objective: To describe 12-month HCV treatment outcomes, estimated glomerular filtration rate (eGFR), and quality of life for the 10 kidney recipients in THINKER-1 and 6-month data on 10 additional recipients.Design: Open-label, nonrandomized trial. (ClinicalTrials.gov: NCT02743897)Setting: Single center.Participants: 20 HCV-negative transplant candidates.Intervention: Participants underwent transplant with kidneys infected with genotype 1 HCV and received elbasvir-grazoprevir on posttransplant day 3.Measurements: The primary outcome was HCV cure. Exploratory outcomes included 1) RAND-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) quality-of-life scores at enrollment and after transplant, and 2) posttransplant renal function, which was compared in a 1:5 matched sample with recipients of HCV-negative kidneys.Results: The mean age of THINKER participants was 56.3 years (SD, 6.7), 70% were male, and 40% were black. All 20 participants achieved HCV cure. Hepatic and renal complications were transient or were successfully managed. Mean PCS and MCS quality-of-life scores decreased at 4 weeks; PCS scores then increased above pretransplant values, whereas MCS scores returned to baseline values. Estimated GFRs were similar between THINKER participants and matched recipients of HCV-negative kidneys at 6 months (median, 67.5 vs. 66.2 mL/min/1.73m(2); 95% CI for between-group difference, -4.2 to 7.5 mL/min/1.73m(2)) and 12 months (median, 72.8 vs. 67.2 mL/min/1.73m(2); CI for between-group difference, -7.2 to 9.8 mL/min/1.73m(2)).Limitation: Small trial.Conclusion: Twenty HCV-negative recipients of HCV-infected kidneys experienced HCV cure, good quality of life, and excellent renal function. Kidneys from HCV-infected donors may be a valuable transplant resource.