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Randomized Controlled Trial
. 2013 Jan;13(1):136-45.
doi: 10.1111/j.1600-6143.2012.04320.x. Epub 2012 Nov 8.

Polyomavirus BK replication in de novo kidney transplant patients receiving tacrolimus or cyclosporine: a prospective, randomized, multicenter study

H H Hirsch  1 , F Vincenti, S Friman, M Tuncer, F Citterio, A Wiecek, E H Scheuermann, M Klinger, G Russ, M D Pescovitz, H Prestele
Affiliations
Free PMC article
Randomized Controlled Trial

Polyomavirus BK replication in de novo kidney transplant patients receiving tacrolimus or cyclosporine: a prospective, randomized, multicenter study

H H Hirsch et al. Am J Transplant. 2013 Jan.
Free PMC article

Abstract

Polyomavirus BK (BKV)-associated nephropathy causes premature kidney transplant (KT) failure. BKV viruria and viremia are biomarkers of disease progression, but associated risk factors are controversial. A total of 682 KT patients receiving basiliximab, mycophenolic acid (MPA), corticosteroids were randomized 1:1 to cyclosporine (CsA) or tacrolimus (Tac). Risk factors were analyzed in 629 (92.2%) patients having at least 2 BKV measurements until month 12 posttransplant. Univariate analysis associated CsA-MPA with lower rates of viremia than Tac-MPA at month 6 (10.6% vs. 16.3%, p = 0.048) and 12 (4.8% vs. 12.1%, p = 0.004) and lower plasma BKV loads at month 12 (3.9 vs. 5.1 log(10) copies/mL; p = 0.028). In multivariate models, CsA-MPA remained associated with less viremia than Tac-MPA at month 6 (OR 0.60; 95% CI 0.36-0.99) and month 12 (OR 0.33; 95% CI 0.16-0.68). Viremia at month 6 was also independently associated with higher steroid exposure until month 3 (OR 1.19 per 1 g), and with male gender (OR 2.49) and recipient age (OR 1.14 per 10 years) at month 12. The data suggest a dynamic risk factor evolution of BKV viremia consisting of higher corticosteroids until month 3, Tac-MPA compared to CsA-MPA at month 6 and Tac-MPA, older age, male gender at month 12 posttransplant.

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Figures

Figure 1
Figure 1. BKV viruria and viremia after kidney transplantation
(A) Cumulative new-onset BKV replication posttransplant; (B) point prevalence at the times of testing (patient sample number below); (C) viral load in new-onset BKV viruria posttransplant; (D) viral load in new-onset BKV viremia postransplant
Figure 2
Figure 2. BKV viruria and viremia rates according to the treatment arm
(A) BKV viruria; (B) BKV viruria above 7 log10 geq/mL (high-level viruria); (C) urine BKV loads in viruric patients; (D) BKV viremia; (E) BKV viremia above 4 log10 geq/mL (high-level viremia); (F) plasma BKV loads in viremic patients.
Figure 3
Figure 3
Mycophenolate dosing over time posttransplant by calcineurin inhibitor.
See this image and copyright information in PMC

References

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