Shi Yiyun, Lerner Alexis Hope, Rogers Ralph, Vieira Kendra, Merhi Basma, Mecadon Krista, Osband Adena J, Bayliss George, Gohh Reginald, Morrissey Paul, Farmakiotis Dimitrios
12321Warren Alpert Medical School of Brown University, Providence, RI, USA.
Lifespan Pharmacy, Providence, RI, USA.
Prog Transplant. 2021 Dec;31(4):368-376. doi: 10.1177/15269248211046037.
Observational studies suggest that low-dose valganciclovir prophylaxis (450 mg daily for normal renal function) is as effective as and perhaps safer than standard-dose valganciclovir (900 mg daily) in preventing CMV infection among kidney transplant recipients. However, this practice is not supported by current guidelines due to concerns for breakthrough infection from resistant CMV, mainly in high-risk CMV donor-seropositive/recipient-seronegative kidney transplant recipients. Standard-dose valganciclovir is costly and possibly associated with higher incidence of neutropenia and BKV DNAemia. Our institution adopted low-dose valganciclovir prophylaxis for intermediate-risk (seropositive) kidney transplant recipients in January 2018. To analyze the efficacy (CMV DNAemia), safety (BK virus DNAemia, neutropenia, graft loss, and death), and cost savings associated with this change. We retrospectively compared the above outcomes between CMV-seropositive kidney transplant recipients who received low-dose and standard-dose valganciclovir, transplanted within our institution, between 1/19/2014 and 7/15/2019, using propensity score-adjusted competing risk analyses. We also compared cost estimates between the two dosing regimens, for 3 months of prophylaxis, and for different percentage of patient-weeks with normal renal function, using the current average wholesale price of valganciclovir. We studied 179 CMV-seropositive kidney transplant recipients, of whom 55 received low-dose and 124 standard-dose valganciclovir. The majority received nonlymphocyte depleting induction (basiliximab). Low-dose valganciclovir was at least as effective and safe as, and more cost-saving than standard-dose valganciclovir. This single-center study contributes to mounting evidence for future guidelines to be adjusted in favor of low-dose valganciclovir prophylaxis in CMV-seropositive kidney transplant recipients.
观察性研究表明，在预防肾移植受者巨细胞病毒（CMV）感染方面，低剂量缬更昔洛韦预防治疗（肾功能正常者每日450毫克）与标准剂量缬更昔洛韦（每日900毫克）效果相当，甚至可能更安全。然而，由于担心耐药CMV引起的突破性感染，主要是在高危CMV供体血清阳性/受体血清阴性的肾移植受者中，目前的指南并不支持这种做法。标准剂量的缬更昔洛韦成本高昂，并且可能与中性粒细胞减少症和BK病毒血症的发生率较高有关。我们机构于2018年1月对中度风险（血清阳性）的肾移植受者采用了低剂量缬更昔洛韦预防治疗。为了分析这种改变所带来的疗效（CMV病毒血症）、安全性（BK病毒血症、中性粒细胞减少症、移植肾丢失和死亡）以及成本节约情况。我们使用倾向评分调整的竞争风险分析方法，对2014年1月19日至2019年7月15日期间在我们机构接受移植的CMV血清阳性肾移植受者中，接受低剂量和标准剂量缬更昔洛韦治疗的患者的上述结局进行了回顾性比较。我们还使用缬更昔洛韦当前的平均批发价格，比较了两种给药方案在3个月预防治疗期间以及不同肾功能正常患者周数百分比情况下的成本估算。我们研究了179例CMV血清阳性的肾移植受者，其中55例接受低剂量缬更昔洛韦治疗，124例接受标准剂量缬更昔洛韦治疗。大多数患者接受了非淋巴细胞清除诱导治疗（巴利昔单抗）。低剂量缬更昔洛韦至少与标准剂量缬更昔洛韦一样有效和安全，并且成本更低。这项单中心研究为未来指南调整以支持对CMV血清阳性肾移植受者采用低剂量缬更昔洛韦预防治疗提供了越来越多的证据。
