Hirsch Hans H
Transplantation & Clinical Virology, Department of Biomedicine, University of Basel, Basel Switzerland.
Kidney Int. 2025 Feb;107(2):230-233. doi: 10.1016/j.kint.2024.10.019.
BK polyomavirus remains a vexing issue in kidney transplantation. There are no antiviral drugs, and solely reducing immunosuppression is recommended for management. However, evidence from randomized controlled studies lacks defining clearance of BK polyomavirus-DNAemia and/or nephropathy as a primary outcome. In this arena of strong opinions, hesitancy, and poor industry interest, Caillard et al. from 16 centers in France take the bull by the horns and present compelling data on clearance of new-onset BK polyomavirus-DNAemia at 6 months after randomizing 130 kidney transplant patients 1:1 to reduced calcineurin inhibitors plus reduced mycophenolate or switching to everolimus. Although both protocols preserve renal allograft function, the mycophenolate arm performs better numerically and kinetically. Thus, everolimus cannot unfold its presumed antiviral effect. The study has potential to serve as new reference for reducing immunosuppression, being neither "mycophenolate first" nor "calcineurin inhibitors first," but "first both." The bar has been set very high now for other interventions alone or on top of "first both."
BK多瘤病毒在肾移植中仍然是一个棘手的问题。目前尚无抗病毒药物,治疗建议仅为减少免疫抑制。然而,随机对照研究的证据缺乏将BK多瘤病毒血症和/或肾病的清除率定义为主要结局。在这个充满强烈观点、犹豫不决和行业兴趣不高的领域,来自法国16个中心的凯亚德等人迎难而上,在将130例肾移植患者按1:1随机分组,分别接受减少钙调神经磷酸酶抑制剂加减少霉酚酸酯治疗或改用依维莫司治疗后6个月,给出了关于新发BK多瘤病毒血症清除率的令人信服的数据。虽然两种方案都能维持肾移植功能,但霉酚酸酯组在数值和动力学方面表现更好。因此,依维莫司无法发挥其假定的抗病毒作用。该研究有可能成为减少免疫抑制的新参考,既不是“先使用霉酚酸酯”,也不是“先使用钙调神经磷酸酶抑制剂”,而是“两者同时先用”。现在,对于单独或在“两者同时先用”基础上的其他干预措施而言,标准已经定得非常高了。