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

摘要

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.