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直接作用抗病毒药物治疗肾移植受者丙型肝炎的安全性和疗效。

Safety and Efficacy of Treatment of Hepatitis C in Kidney Transplant Recipients With Directly Acting Antiviral Agents.

机构信息

1 Division of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY. 2 Division of Medicine, Columbia University Medical Center, New York, NY.

出版信息

Transplantation. 2017 Jul;101(7):1704-1710. doi: 10.1097/TP.0000000000001618.

Abstract

BACKGROUND

With the development of all oral, interferon-free directly acting antiviral (DAA) medications, treatment of hepatitis C virus (HCV) infection in renal transplant recipients is possible, but limited data exists on its safety and efficacy.

METHODS

We performed a retrospective cohort analysis of patients transplanted at our center with HCV who have been started on DAAs. Primary endpoints included sustained virologic response as defined as negative viral load at 12 weeks postcompletion of therapy and allograft function.

RESULTS

A total of 31 patients met inclusion criteria. The most commonly used regimen was sofosbuvir and ledipasvir (n = 21). Of the treated patients, 100% had undetectable viral load at the completion of therapy. Of the 31 patients treated, 30 (97%) achieved sustained virologic response. Both graft and patient survivals at most recent follow-up was 100%. There was no significant change in glomerular filtration rate (GFR) before or after therapy (64.2 ± 16.5 mL/min per body surface area before vs. 58.9 ± 17.5 mL/min per body surface area after therapy; P = 0.22); however, 3 patients now have GFR less than 20. A total of 6 (19.3%) of 31 patients had worsening proteinuria during or shortly after therapy. Patients with more than 500 mg/g of proteinuria at the start of treatment were significantly more likely to develop worsening proteinuria than those with less than 500 mg/g of proteinuria at the start of therapy (P < 0.001). Retrospective review of 20 untreated HCV patients did not demonstrate worsening allograft function and proteinuria during a median follow-up time of 1386 days (range, 332-6254).

CONCLUSIONS

Our preliminary data demonstrate that DAAs can be used safely and effectively in patients after kidney transplantation. Patients with proteinuria or lower GFR should be monitored more closely.

摘要

背景

随着所有口服、无干扰素的直接作用抗病毒 (DAA) 药物的发展,对肾移植受者的丙型肝炎病毒 (HCV) 感染进行治疗成为可能,但关于其安全性和疗效的数据有限。

方法

我们对在我们中心接受 HCV 治疗并开始使用 DAA 的患者进行了回顾性队列分析。主要终点包括根据治疗完成后 12 周时病毒载量是否阴性定义的持续病毒学应答和移植物功能。

结果

共有 31 名患者符合纳入标准。最常用的方案是索磷布韦和雷迪帕韦(n = 21)。在接受治疗的患者中,100%在治疗完成时病毒载量不可检测。在接受治疗的 31 名患者中,30 名(97%)达到了持续病毒学应答。截至最近随访时,移植物和患者的存活率均为 100%。治疗前后肾小球滤过率(GFR)无显著变化(治疗前 64.2 ± 16.5 mL/min/体表面积,治疗后 58.9 ± 17.5 mL/min/体表面积;P = 0.22);然而,现在有 3 名患者的 GFR 低于 20。共有 6 名(19.3%)患者在治疗期间或治疗后不久出现蛋白尿加重。与治疗开始时蛋白尿小于 500 mg/g 的患者相比,治疗开始时蛋白尿大于 500 mg/g 的患者发生蛋白尿加重的可能性显著更高(P < 0.001)。对 20 名未接受治疗的 HCV 患者的回顾性分析显示,在中位随访时间为 1386 天(范围为 332-6254 天)期间,移植物功能和蛋白尿无恶化。

结论

我们的初步数据表明,DAA 可安全有效地用于肾移植后患者。有蛋白尿或较低 GFR 的患者应更密切监测。

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