Cytomegalovirus: occurrence, severity, and effect on graft survival in simultaneous pancreas-kidney transplantation

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.