title: Extended valganciclovir prophylaxis in D+/R- kidney transplant recipients is associated with long-term reduction in cytomegalovirus disease: two-year results of the IMPACT study.
abstract: BACKGROUND
  Whether the early reduction in cytomegalovirus (CMV) disease seen at 1 year with prolongation of antiviral prophylaxis (up to 200 days) persists in the long term is unknown.
  
  
  METHODS
  This international, randomized, prospective, double-blind study, compared 318 CMV D+/R- kidney transplant recipients receiving valganciclovir (900 mg) once daily for up to 200 days vs. 100 days. Long-term outcomes including CMV disease, acute rejection, graft loss, patient survival, and seroconversion were assessed.
  
  
  RESULTS
  At 2 years posttransplant, CMV disease occurred in significantly less patients in the 200- vs. the 100-day group: 21.3% vs. 38.7%, respectively (P<0.001). Between year 1 and 2, there were only 10 new cases of CMV disease; 7 in the 200-day group and 3 in the 100-day group. Patient survival was 100% in the 200-day group and 97% in the 100-day group (p=not significant). Biopsy-proven acute rejection and graft loss rates were comparable in both groups (11.6% vs. 17.2%, P=0.16, and 1.9% vs. 4.3%, P=0.22, in the 200-day vs. 100-day groups, respectively). Seroconversion was delayed in the 200-day group but was similar to the 100-day group by 2 years posttransplant (IgM or IgG seroconversion; 55.5% in the 200-day group vs. 62.0% in the 100-day group at 2-years; P=0.26). Assessment of seroconversion at the end of prophylaxis was of limited utility for predicting late-onset CMV disease.
  
  
  CONCLUSIONS
  Extending valganciclovir prophylaxis from 100 to 200 days is associated with a sustained reduction in CMV disease up to 2 years posttransplant.
authors.affiliation: Transplant Infectious Diseases, University of Alberta, Edmonton, AB, Canada. ahumar@ualberta.ca
authors.forename: Atul
authors.initials: A
authors.lastname: Humar
authors.forename: Ajit P
authors.initials: AP
authors.lastname: Limaye
authors.forename: Emily A
authors.initials: EA
authors.lastname: Blumberg
authors.forename: Ingeborg A
authors.initials: IA
authors.lastname: Hauser
authors.forename: Flavio
authors.initials: F
authors.lastname: Vincenti
authors.forename: Alan G
authors.initials: AG
authors.lastname: Jardine
authors.forename: Daniel
authors.initials: D
authors.lastname: Abramowicz
authors.forename: Jane A L
authors.initials: JA
authors.lastname: Ives
authors.forename: Mahdi
authors.initials: M
authors.lastname: Farhan
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006085:Graft Survival; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D016030:Kidney Transplantation / Q000009:adverse effects / Q000401:mortality / Q000502:physiology*; D016013:Likelihood Functions; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012698:Serologic Tests / Q000706:statistics & numerical data; D015996:Survival Rate; D013997:Time Factors; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D000077562:Valganciclovir; D015774:Ganciclovir