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无 HCV 基因型/基因亚型检测的 Sofosbuvir/Velpatasvir 治疗方案在中国应用于 HCV 血症肾的经验

Utilization of HCV Viremic Kidneys with Genotyping/Subtyping-Free Sofosbuvir/Velpatasvir Treatment Strategy: Experience from China.

机构信息

Department of Kidney Transplantation, The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China.

Clinical Research Center for Organ Transplantation in Hunan Province, Changsha, China.

出版信息

Biomed Res Int. 2022 Jul 30;2022:3758744. doi: 10.1155/2022/3758744. eCollection 2022.

Abstract

BACKGROUND

Owing to the advent of pangenotypic direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) treatment, utilization of HCV-infected deceased donor kidneys with simplified genotyping/subtyping-free sofosbuvir/velpatasvir (SOF/VEL) treatment strategy is now becoming a promising strategy for expanding the organ donor pool.

METHODS

This retrospective, comparative, single-center study included HCV viremic donor kidneys that were transplanted to 9 HCV-positive (HCV Ab-positive) recipients (D+/R+ group) and 14 HCV-negative recipients (D+/R- group) from May 2018 to January 2021. Both groups received prophylaxis with SOF/VEL treatment within 1-week posttransplant devoid of HCV genotyping/subtyping. The primary outcomes were sustained virologic response 12 weeks after completion of therapy (SVR12) and graft survival at 1-year posttransplant.

RESULTS

Baseline characteristics were similar between the HCV D+/R- and D+/R+ groups. The mean age of all recipients was 39.09 ± 9.65 (SD) years, and 73.9% were male. A total of 92.9% (13 out of 14) recipients had pretreatment HCV viremia in the D+/R- group. The pretreatment HCV viral load in the D+/R+ group (5.98, log 10 IU/mL; IQR, 5.28-6.53) was significantly higher than that in the D+/R- group (3.61, log 10 IU/mL; IQR, 2.57-4.57). After SOF/VEL treatment, SVR12 was achieved in all recipients, with a 100% 1-year patient and graft survival rates. The D+/R+ group had a higher incidence of abnormal liver function (44.4% vs. 7.1%). No significant difference was observed between the two groups in terms of DGF, acute rejection, ALT, serum creatinine, and eGFR within 1-year posttransplant. No severe adverse events associated with either HCV viremia or SOF/VEL were observed.

CONCLUSIONS

Using a simplified genotyping/subtyping-free SOF/VEL treatment strategy, kidneys from hepatitis C viremic donors for both infected and uninfected recipients presented with safe, excellent, and comparable 1-year outcomes, which can safely expand the donor pool. HCV-positive donor kidneys should be utilized regularly, regardless of the recipient's HCV status.

摘要

背景

由于治疗丙型肝炎病毒 (HCV) 的泛基因型直接作用抗病毒药物 (DAA) 的出现,简化基因型/亚型检测的 HCV 感染供体肾与索磷布韦/维帕他韦(SOF/VEL)治疗策略的联合应用,现已成为扩大器官供体库的一种有前途的策略。

方法

这是一项回顾性、对照、单中心研究,纳入了 2018 年 5 月至 2021 年 1 月期间 HCV 病毒血症供体肾移植给 9 名 HCV 阳性(抗 HCV 阳性)受者(D+/R+组)和 14 名 HCV 阴性受者(D+/R-组)的病例。两组受者在移植后 1 周内均接受 SOF/VEL 治疗预防,不进行 HCV 基因型/亚型检测。主要结局是治疗完成后 12 周的持续病毒学应答(SVR12)和移植后 1 年的移植物存活率。

结果

D+/R-组和 D+/R+组的基线特征相似。所有受者的平均年龄为 39.09±9.65(标准差)岁,73.9%为男性。D+/R-组中,共有 92.9%(13/14)的受者在治疗前有 HCV 病毒血症。D+/R+组的治疗前 HCV 病毒载量(5.98,log10 IU/mL;IQR,5.28-6.53)显著高于 D+/R-组(3.61,log10 IU/mL;IQR,2.57-4.57)。所有受者在接受 SOF/VEL 治疗后均达到 SVR12,1 年患者和移植物存活率均为 100%。D+/R+组肝功能异常发生率较高(44.4% vs. 7.1%)。移植后 1 年内,两组间 DGF、急性排斥反应、ALT、血清肌酐和 eGFR 无显著差异。未观察到与 HCV 病毒血症或 SOF/VEL 相关的严重不良事件。

结论

采用简化基因型/亚型检测的 SOF/VEL 治疗策略,HCV 病毒血症供体肾用于感染和未感染受者,具有安全、良好和可比的 1 年结局,可安全扩大供体库。HCV 阳性供体肾应常规使用,而无需考虑受者的 HCV 状态。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e92d/9356870/b56ae2b94adb/BMRI2022-3758744.001.jpg

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