Prophylactic 2-week Glecaprevir/Pibrentasvir in Hepatitis C positive to negative kidney transplantation.

IF 4.8 2区 医学 Q1 TRANSPLANTATION Nephrology Dialysis Transplantation Pub Date : 2024-11-20 DOI:10.1093/ndt/gfae271
Rebecca A Dieter, Aprajita Mattoo, Perry Hotchkis, Ian S Jaffe, Elaina P Weldon, Jonathan C Berger, Nicole M Ali, Robert A Montgomery, Bonnie E Lonze
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Abstract

Background and hypothesis: Hepatitis C virus (HCV) positive-to-negative kidney transplants (KT) require direct acting antiviral therapy, but the optimal timing and duration remain unclear. We hypothesized that 14-day prophylactic course of glecaprevir/pibrentasvir 300/120 mg (GLE/PIB) would be safe and effective at treating donor-derived HCV viremia.

Methods: This was a prospective, single-center, single-arm, open-label pilot study. 20 adult HCV negative recipients of HCV nucleic acid amplification test positive deceased-donor kidneys (HCV positive-to-negative) received a 14-day course of GLE/PIB, with the first dose pre-transplant. HCV RNA viral loads (VL) were monitored on post-operative days (POD) 1, 3, 7, and 13. If VL was undetectable on POD 13, GLE/PIB was stopped, and if detectable, GLE/PIB was continued to complete an 8-week course. Surveillance monitoring continued after treatment to ensure sustained viral response (SVR). The primary outcome was efficacy of 14-day prophylactic GLE/PIB. Secondary outcomes included patient and allograft survival, the incidence, timing, and clearance of HCV viremia, and safety events.

Results: 7/20 subjects (35%) never developed detectable HCV viremia. Only one subject had a detectable, but nonquantifiable, VL on POD 13 and completed an 8-week course. All subjects achieved SVR 12 weeks post-treatment with no relapses through 1-year follow-up. Mean time to undetectable HCV RNA VL was 10.5 (±4.7) days and mean peak VL was 371 (±715) copies/mL. 6-month and 1-year patient and allograft survival were 100% and 95%.

Conclusion: A 14-day course of prophylactic GLE/PIB is safe and effective for HCV positive-to-negative KT and may prevent HCV transmission or significantly reduce the VL for those with detectable transmission allowing for rapid clearance within 2 weeks.

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在丙型肝炎阳性转阴肾移植中预防性使用 2 周 Glecaprevir/Pibrentasvir。
背景和假设:丙型肝炎病毒(HCV)阳性转阴性肾移植(KT)需要直接作用抗病毒治疗,但最佳治疗时机和疗程仍不明确。我们假设格列卡韦/匹布伦达韦 300/120 毫克(GLE/PIB)的 14 天预防性疗程将安全有效地治疗供体源性 HCV 病毒血症:这是一项前瞻性、单中心、单臂、开放标签试验研究。20名HCV核酸扩增检测呈阳性的已故供肾的成人HCV阴性受者(HCV阳性转阴性)接受了为期14天的GLE/PIB治疗,第一剂在移植前服用。术后第 1、3、7 和 13 天(POD)监测 HCV RNA 病毒载量(VL)。如果在 POD 13 检测不到 VL,则停用 GLE/PIB;如果检测到 VL,则继续使用 GLE/PIB 完成为期 8 周的疗程。治疗后继续进行监测,以确保持续病毒应答(SVR)。主要结果是 14 天预防性 GLE/PIB 的疗效。次要结果包括患者和异体移植存活率、HCV 病毒血症的发生率、时间和清除率以及安全性事件:结果:7/20 例受试者(35%)从未检测到 HCV 病毒血症。只有一名受试者在 POD 13 检测到 VL,但无法量化,并完成了为期 8 周的疗程。所有受试者在治疗后 12 周均获得 SVR,随访 1 年无复发。检测不到 HCV RNA VL 的平均时间为 10.5 (±4.7) 天,平均峰值 VL 为 371 (±715) 拷贝/毫升。患者6个月和1年的存活率分别为100%和95%:14天的预防性GLE/PIB疗程对HCV阳性转阴性的KT是安全有效的,可预防HCV传播或显著降低可检测到传播的患者的VL,使其在2周内快速清除。
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来源期刊
Nephrology Dialysis Transplantation
Nephrology Dialysis Transplantation 医学-泌尿学与肾脏学
CiteScore
10.10
自引率
4.90%
发文量
1431
审稿时长
1.7 months
期刊介绍: Nephrology Dialysis Transplantation (ndt) is the leading nephrology journal in Europe and renowned worldwide, devoted to original clinical and laboratory research in nephrology, dialysis and transplantation. ndt is an official journal of the [ERA-EDTA](http://www.era-edta.org/) (European Renal Association-European Dialysis and Transplant Association). Published monthly, the journal provides an essential resource for researchers and clinicians throughout the world. All research articles in this journal have undergone peer review. Print ISSN: 0931-0509.
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