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Incidence and outcome of BK polyomavirus infection in a multicenter randomized controlled trial with renal transplant patients receiving cyclosporine‐, mycophenolate sodium‐, or everolimus‐based low‐dose immunosuppressive therapy
Author(s) -
Doesum Willem B.,
Gard Lilli,
Bemelman Frederike J.,
Fijter Johan W.,
Homan van der Heide Jaap J.,
Niesters Hubert G.,
Son Willem J.,
Stegeman Coen A.,
Groen Henk,
RiezebosBrilman Annelies,
Sanders Jan Stephan F.
Publication year - 2017
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1111/tid.12687
Subject(s) - medicine , everolimus , immunosuppression , gastroenterology , mycophenolic acid , mycophenolate , randomized controlled trial , urology , incidence (geometry) , transplantation , physics , optics
Background It remains unclear whether overall degree of immunosuppression or specific effects of individual immunosuppressive agents are causal for increased occurrence of BK polyomavirus ( BKP yV) infection in renal transplant recipients ( RTR ). Methods A prospective, multicenter, open‐label randomized controlled trial in 361 de novo RTR was performed. A total of 224 RTR were randomized at 6 months into three treatment groups with dual therapy consisting of prednisolone (Pred) plus either cyclosporine (CsA), mycophenolate sodium ( MPS ), or everolimus ( EVL ). Primary outcomes were incidence of BK viruria, BK viremia, and BKP yV‐associated nephropathy ( BKVAN ). Results From 6 months, incidence of BK viruria in the MPS group (43.6%) was significantly higher than in the other groups (CsA: 16.9%, EVL : 19.8%) ( P =.003). BKVAN was diagnosed in 3 patients, all treated with MPS (7.8%, P =.001). Longitudinal data analysis showed a lower BKP yV load and a significantly faster clearance of BK viruria in the CsA group compared to the MPS group ( P =.03). Conclusions Treatment with MPS was associated with an increased incidence of BK viruria. Dual immunosuppressive therapy with CsA and Pred was associated with the lowest rate of BKP yV replication and the fastest clearance of the virus.