Cytomegalovirus: occurrence, severity, and effect on graft survival in simultaneous pancreas–kidney transplantation
1 Renal Transplant Unit, 2 Infectious Diseases Service, 3 Department of Surgery, Hospital Clínic, University of Barcelona, Spain, 4 Department of Kidney and Pancreas Transplantation, Cliniques Universitaires St Luc, Université Catholique de Louvain, Brussels, Belgium
Correspondence and offprint requests to: Dr Jacques Malaise, Department of Kidney and Pancreas Transplantation and Organ Procurement, Cliniques Universitaires St Luc, Université Catholique de Louvain, Avenue Hippocrate, 10/2207, B-1200 Brussels, Belgium. Email: jacques.malaise{at}chir.ucl.ac.be
Background. This analysis of the Euro-SPK 001 study examined the occurrence and effect of cytomegalovirus (CMV) infection during the first 3 years after simultaneous pancreas–kidney (SPK) transplantation.
Methods. In this multicentre study, 205 SPK transplant patients were randomized to immunosuppressive treatment with tacrolimus (n = 103) or cyclosporin microemulsion [(ME), n = 102]. All patients received antibody induction therapy, mycophenolate mofetil and short-term corticosteroids. The choice of CMV prophylaxis and treatment was at the discretion of each investigator.
Results. The overall incidence of CMV infection was 34%, with equal distribution in the tacrolimus and cyclosporin-ME groups. Fewer CMV infections occurred with ganciclovir (22%) than aciclovir (43% P = 0.007) or no prophylaxis (42%, P = 0.008). The rates of CMV infection according to donor and recipient CMV serological status were: D–/R– 11%; D–/R+ (40%, P = 0.004); D+/R+ (37%, P = 0.002); and D+/R– (52%, P<0.001). In the three at-risk subgroups, infection rates were lower among patients receiving ganciclovir (22%) than among those receiving aciclovir or no prophylaxis (64%; P<0.0001). Acute rejection was more common among CMV-infected patients (66 vs 41% without infection, P = 0.001) and in those not receiving ganciclovir prophylaxis. The 3-year actuarial rejection-free survival rate was 61.4% with ganciclovir and 42.2% with no prophylaxis or aciclovir alone (P = 0.002). No differences were observed in actuarial patient, kidney or pancreas survival between CMV and non-CMV infection groups.
Conclusions. Our findings confirm that the incidence of CMV infection is the same in tacrolimus- and cyclosporin-ME-treated SPK recipients. Ganciclovir prophylaxis effectively prevented CMV infection, especially in higher risk groups, and was associated with a reduced incidence of rejection compared with aciclovir/no prophylaxis.
Keywords: acute rejection; cyclosporin microemulsion; CMV infection; ganciclovir; kidney–pancreas transplantation; tacrolimus