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在肾移植受者中延迟起始、缩短疗程使用 glecaprevir/pibrentasvir 与标准治疗方案治疗供体来源丙型肝炎病毒的真实世界经验。

Real-world experience in treatment of donor-derived Hepatitis C virus in kidney transplant recipients with delayed initiation, shortened course glecaprevir/pibrentasvir versus standard of care.

作者信息

Papanikolla Johanna, McGowan Melissa, Chunduru Mythili, Winters Holli, Pesavento Todd, Smith Rachel, Singh Navdeep, Wellner Michael, Sobotka Lindsay, Nolan Annelise

机构信息

Department of Pharmacy, The Ohio State University, Columbus, Ohio, USA.

Department of Pharmacy, TriStar Summit Medical Center, Nashville, Tennessee, USA.

出版信息

Transpl Infect Dis. 2024 Dec;26(6):e14366. doi: 10.1111/tid.14366. Epub 2024 Sep 3.

Abstract

BACKGROUND

There is limited literature describing the real-world practice of delayed initiation and shortened duration direct-acting antiviral (DAA) in kidney transplant recipients. We compared Hepatitis C virus (HCV) cure rates among kidney transplant recipients who received an HCV nucleic acid test positive (NAT +) kidney and were treated with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks or glecaprevir/pibrentasvir (G/P) for 8 weeks, a duration that is 4 weeks shorter than the guideline recommendation for treatment delay beyond 1-week post-transplant.

METHODS

Retrospective study of HCV-negative adult patients who received a kidney transplant from an HCV NAT+ donor between April 2019 and April 2022 treated with either SOF/VEL for 12 weeks or G/P for 8 weeks. The primary outcome was sustained virologic response 12 weeks after completion of therapy (SVR12). Secondary outcomes included time to DAA initiation, renal function, graft loss, patient death, liver function tests, and opportunistic infections.

RESULTS

102 kidney transplant recipients were included with 36 treated with G/P and 66 treated with SOF/VEL. All 36 (100%) treated with G/P achieved SVR12. One patient in the SOF/VEL group failed to achieve SVR12 but received additional therapy and was cured. Time to DAA initiation was similar with a mean of 4 weeks. There was no difference in AST/ALT > 3x ULN or renal function. One rejection occurred in each group. No patient death or graft loss was observed. There was no difference in cytomegalovirus and BK viremia between groups.  CONCLUSION: Delayed initiation of DAA therapy with 12 weeks of SOF/VEL or 8 weeks of G/P achieves SVR12 in kidney transplant recipients without significant adverse effects.

摘要

背景

描述肾移植受者延迟启动和缩短疗程直接抗病毒药物(DAA)实际应用情况的文献有限。我们比较了接受丙型肝炎病毒(HCV)核酸检测呈阳性(NAT+)肾脏移植且接受索磷布韦/维帕他韦(SOF/VEL)治疗12周或格卡瑞韦/哌仑他韦(G/P)治疗8周的肾移植受者的HCV治愈率,该疗程比移植后1周以上延迟治疗的指南推荐疗程短4周。

方法

对2019年4月至2022年4月期间接受来自HCV NAT+供体肾脏移植的HCV阴性成年患者进行回顾性研究,这些患者接受SOF/VEL治疗12周或G/P治疗8周。主要结局是治疗完成后12周的持续病毒学应答(SVR12)。次要结局包括启动DAA的时间、肾功能、移植肾丢失、患者死亡、肝功能检查和机会性感染。

结果

纳入102例肾移植受者,其中36例接受G/P治疗,66例接受SOF/VEL治疗。所有36例(100%)接受G/P治疗的患者均实现SVR12。SOF/VEL组有1例患者未实现SVR12,但接受了额外治疗并治愈。启动DAA的时间相似,平均为4周。AST/ALT>3倍ULN或肾功能无差异。每组各发生1次排斥反应。未观察到患者死亡或移植肾丢失。两组间巨细胞病毒和BK病毒血症无差异。

结论

延迟启动DAA治疗,采用12周的SOF/VEL或8周的G/P,可使肾移植受者实现SVR12,且无明显不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27fc/11666865/8c23a9b6d92e/TID-26-e14366-g001.jpg

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