title: Impact of valganciclovir prophylaxis on the development of severe late-cytomegalovirus disease in high-risk solid organ transplant recipients.
abstract: BACKGROUND
  With the introduction of prolonged prophylaxis with valganciclovir in cytomegalovirus (CMV) donor/recipient serodiscordance (D+/R-) patients, concerns about a high incidence of late and invasive CMV disease associated with mortality have emerged. We compared the characteristics of CMV disease in D+/R- patients receiving prolonged valganciclovir prophylaxis with R+ patients.
  
  
  METHODS
  We prospectively followed all solid organ transplant recipients from January 2004 to December 2005. CMV prophylaxis with valganciclovir or ganciclovir was administered as follows: donor- recipient serodiscordance (D+/R-), 12 weeks; induction with antithymocyte globulin or acute rejection episodes requiring steroid pulses, 15 to 30 days; and CMV R+ double kidney-pancreas, 15 days. Transplant characteristics and the development of CMV disease variables were collected for all patients. We defined 2 groups according to the risk of CMV disease: CMV donor/recipient mismatch (D+/R-) and recipient CMV-positive (R+) groups.
  
  
  RESULTS
  During the study period we performed 481 solid organ transplantations: 237 kidney, 34 kidney-pancreas, 157 liver, 38 heart, 13 liver-kidney, and 2 heart-kidney. Overall, 36 patients developed CMV disease (7.5%). CMV donor-recipient mismatch (D+/R-) was associated with a greater risk of CMV disease compared with CMV-positive recipients (16% vs 7%; P = .036). Prophylaxis against CMV was longer in the D+/R- group (mean days 73 vs 15; P < .001). CMV disease appeared later in the D+/R- than in R+ group (mean days 123 vs 59; P < .001). We observed a trend toward a lower incidence of tissue-invasive CMV disease among the D+/R- group compared with the R+ group without significance (14% vs 41%; P = .382). Three patients died in the first 30 days after the onset of CMV disease, all of them in the R+ group.
  
  
  CONCLUSIONS
  In our setting, high-risk patients (D+/R-) receiving prolonged prophylaxis with valganciclovir developed later CMV disease, but this was neither more tissue-invasive nor more life-threatening than in the R+ group.
authors: Infectious Diseases Service, Hospital Clínic-IDIBAPS-University of Barcelona, Barcelona, Spain. ccervera@clinic.ub.es
authors: C
authors: C
authors: Cervera
authors: M
authors: M
authors: Pineda
authors: L
authors: L
authors: Linares
authors: M A
authors: MA
authors: Marcos
authors: C
authors: C
authors: Esteva
authors: A
authors: A
authors: Antón
authors: F
authors: F
authors: Cofán
authors: M J
authors: MJ
authors: Ricart
authors: M
authors: M
authors: Navasa
authors: F
authors: F
authors: Pérez-Villa
authors: T
authors: T
authors: Pumarola
authors: A
authors: A
authors: Moreno
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000009:adverse effects*; D011183:Postoperative Complications / Q000453:epidemiology / Q000821:virology; D011446:Prospective Studies; D014181:Transplantation Immunology; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D000077562:Valganciclovir; D015774:Ganciclovir