Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
Division of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida.
J Am Soc Nephrol. 2020 Nov;31(11):2678-2687. doi: 10.1681/ASN.2020050686. Epub 2020 Aug 25.
Single-center trials and retrospective case series have reported promising outcomes using kidneys from donors with hepatitis C virus (HCV) infection. However, multicenter trials are needed to determine if those findings are generalizable.
We conducted a prospective trial at seven centers to transplant 30 kidneys from deceased donors with HCV viremia into HCV-uninfected recipients, followed by 8 weeks of once-daily coformulated glecaprevir and pibrentasvir, targeted to start 3 days posttransplant. Key outcomes included sustained virologic response (undetectable HCV RNA 12 weeks after completing treatment with glecaprevir and pibrentasvir), adverse events, and allograft function.
We screened 76 patients and enrolled 63 patients, of whom 30 underwent kidney transplantation from an HCV-viremic deceased donor (median kidney donor profile index, 53%) in May 2019 through October 2019. The median time between consent and transplantation of a kidney from an HCV-viremic donor was 6.3 weeks. All 30 recipients achieved a sustained virologic response. One recipient died of complications of sepsis 4 months after achieving a sustained virologic response. No severe adverse events in any patient were deemed likely related to HCV infection or treatment with glecaprevir and pibrentasvir. Three recipients developed acute cellular rejection, which was borderline in one case. Three recipients developed polyomavirus (BK) viremia near or >10,000 copies/ml that resolved after reduction of immunosuppression. All recipients had good allograft function, with a median creatinine of 1.2 mg/dl and median eGFR of 57 ml/min per 1.73 m at 6 months.
Our multicenter trial demonstrated safety and efficacy of transplantation of 30 HCV-viremic kidneys into HCV-negative recipients, followed by early initiation of an 8-week regimen of glecaprevir and pibrentasvir.
单中心试验和回顾性病例系列研究报告称，使用丙型肝炎病毒 (HCV) 感染供体的肾脏可获得有希望的结果。然而，需要进行多中心试验以确定这些发现是否具有普遍性。
我们在七个中心进行了一项前瞻性试验，将 30 个来自 HCV 病毒血症的已故供体的肾脏移植到 HCV 阴性的受者体内，然后在移植后 3 天开始接受为期 8 周的每日一次共配方 glecaprevir 和 pibrentasvir。主要结局包括持续病毒学应答（用 glecaprevir 和 pibrentasvir 治疗 12 周后 HCV RNA 不可检测）、不良事件和移植物功能。
我们筛选了 76 名患者，纳入了 63 名患者，其中 30 名于 2019 年 5 月至 2019 年 10 月期间接受了来自 HCV 病毒血症的已故供体的肾脏移植（中位肾脏供体特征指数为 53%）。从 HCV 病毒血症供体获得的肾脏的移植时间与同意之间的中位时间为 6.3 周。所有 30 名受者均获得持续病毒学应答。1 名受者在获得持续病毒学应答后 4 个月因败血症并发症死亡。没有任何患者的严重不良事件被认为可能与 HCV 感染或 glecaprevir 和 pibrentasvir 治疗有关。3 名受者发生急性细胞排斥反应，1 例为临界病例。3 名受者发生多瘤病毒（BK）血症，病毒载量接近或 >10,000 拷贝/ml，在减少免疫抑制后得到缓解。所有受者的移植物功能良好，6 个月时肌酐中位数为 1.2mg/dl，eGFR 中位数为 57ml/min/1.73m。
我们的多中心试验证明了将 30 个 HCV 病毒血症的肾脏移植到 HCV 阴性的受者体内，然后早期开始接受 8 周的 glecaprevir 和 pibrentasvir 治疗是安全有效的。
