title: Cytomegalovirus: occurrence, severity, and effect on graft survival in simultaneous pancreas-kidney transplantation.
abstract: 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.
authors.affiliation: Renal Transplant Unit, University of Barcelona, Spain.
authors.forename: Maria José
authors.initials: MJ
authors.lastname: Ricart
authors.forename: Jacques
authors.initials: J
authors.lastname: Malaise
authors.forename: Asunción
authors.initials: A
authors.lastname: Moreno
authors.forename: Marta
authors.initials: M
authors.lastname: Crespo
authors.forename: Laureano
authors.initials: L
authors.lastname: Fernández-Cruz
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology; D000998:Antiviral Agents / Q000627:therapeutic use; D016572:Cyclosporine / Q000627:therapeutic use; D003587:Cytomegalovirus / Q000235:genetics / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control; D004279:DNA, Viral / Q000235:genetics; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000627:therapeutic use; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015994:Incidence; D007557:Israel; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D016035:Pancreas Transplantation / Q000009:adverse effects*; D016133:Polymerase Chain Reaction; D012307:Risk Factors; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000914:Antibodies, Viral; D000998:Antiviral Agents; D004279:DNA, Viral; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D015774:Ganciclovir; D016559:Tacrolimus