Abstract
Cytomegalovirus (CMV) syndrome or disease, a serious health hazard after renal transplantation, can be prevented using the antiviral drug (val)ganciclovir. (Val)ganciclovir is typically administered following a prophylactic or a pre-emptive strategy. The prophylactic strategy entails early universal administration, the pre-emptive strategy early treatment in case of infection. However, it is not clear which strategy is superior with respect to transplantation outcome and viral clearance. We have retrospectively analysed 540 patients from the multicentre Harmony study: 308 were treated according to a prophylactic, 232 according to a pre-emptive strategy. As expected, we observed an association of prophylactic strategy with lower incidence of CMV syndrome, delayed onset and lower viral loads compared to the pre-emptive strategy. However, the prophylactic strategy was associated with higher incidence of acute rejection (P=0.002) and – for female patients – a strong impairment of glomerular filtration rate (eGFR) one year post-transplant (P<0.001, median difference: 18.5 mL·min−1·1.73m−2). Additionally, the prophylactic strategy was associated with increased incidence of severe BK virus reactivation. Our results suggest for the first time that the prophylactic strategy might lead to inferior transplantation outcomes, providing evidence for a strong association with sex.
ClinicalTrials.gov number: NCT00724022
Footnotes
Funding sources This work was funded by the German Federal Ministry of Education and Research (BMBF) 01ZX1312. The funder had no role in data collection, data analysis, data interpretation, writing of the manuscript, or manuscript submission.
Abbreviations ATG, Antithymocyte globulin; CMV, Cytomegalovirus; 95% CI, 95% Confidence interval; D−R−, Seronegative donor and seronegative recipient; D+R−, Seropositive donor and seronegative recipient; D+R+, Seropositive donor and seropositive recipient; EBV, Epstein-Barr virus; eGFR, Estimated glomerular filtration rate; eGFR-1y, Estimated glomerular filtration rate one year after transplantation; IQR, Interquartile range; MMF, mycophenolate mofetil; OR, Odds ratio; qPCR, Quantitative polymerase chain reaction; R+, Seropositive Recipient.
Conflict of interest statement OW has received research grants for clinical studies, speaker’s fees, honoraria and travel expenses from Amgen, Astellas, Bristol-Myers Squibb, Chiesi, Janssen-Cilag, MSD, Novartis, Roche, Pfizer, and Sanofi. OW is supported by an unrestricted grant of the Rudolf-Ackermann-Stiftung (Stiftung für Klinische Infektiologie). All other authors have no conflicts of interest to disclose
Affiliations and conflict of interest statement updated