Nephrol Dial Transplant (2003) 18: 1899-1908
© 2003 European Renal Association-European Dialysis and Transplant Association
Pre-emptive therapy of CMVpp65 antigen positive renal transplant recipients with oral ganciclovir: a randomized, comparative study
1 Department of Internal Medicine, 2 Department of Surgery, 3 Laboratory for Renal Physiology and 4 Institute of Medical Microbiology, Rikshospitalet University Hospital, Oslo, Norway
Correspondence and offprint requests to: Solbjørg Sagedal, MD, Department of Medicine, Rikshospitalet University Hospital, N-0027 Oslo, Norway. Email: solbjorg.sagedal{at}rikshospitalet.no
Background. About one-quarter of renal transplant patients will suffer from symptomatic cytomegalovirus (CMV) disease if no preventive therapeutic measures are taken. In this prospective, randomized single-centre study pre-emptive therapy with oral ganciclovir is compared with conventional deferred treatment.
Methods. Renal transplant recipients (n= 455) over 18 years of age were screened weekly for CMV pp65 antigenaemia during the first 12 weeks post-transplantation. If CMV pp65 antigen in leukocytes appeared within 8 weeks post-transplantation patients were randomized and included in the study. Five patients developed CMV disease before positive CMV pp65, and 14 patients with a positive antigen test developed CMV disease before randomization could take place, all these representing a limitation of the applicability of the results in the overall renal transplant population. Altogether 179 patients were not randomized for various reasons. Eighty patients completed the study, 42 were randomized to receive pre-emptive oral ganciclovir therapy and 38 to conventional deferred treatment (control group).
Results. Time from transplantation to start of ganciclovir capsules was 36 (12–60) days and duration of oral ganciclovir therapy was 49 (27–70) days, median (range). No patient in the pre-emptive treatment group, but nine of 38 patients (23.7%) in the control group, developed CMV disease during the first 12 weeks post-transplantation (P= 0.0009). In the period from 3 months to 1 year post-transplantation, two patients in each group developed CMV disease. There were no significant differences in acute rejection or renal function between treatment groups during the first post-transplant year.
Conclusions. Pre-emptive oral ganciclovir therapy in renal transplant recipients during the first 12 weeks post-transplantation effectively prevents CMV disease during this time period. The incidence of late CMV disease (3 months to 1 year after transplantation) was similar in the two groups, indicating that pre-emptive therapy does not result in late onset of CMV disease.
Keywords: cytomegalovirus disease; cytomegalovirus infection; ganciclovir capsules; kidney transplantation; pre-emptive therapy
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