title: Risk factors for cytomegalovirus viremia and disease developing after prophylaxis in high-risk solid-organ transplant recipients.
abstract: BACKGROUND
  Cytomegalovirus (CMV) D+/R- solid-organ transplant (SOT) recipients carry increased risk of developing CMV disease; however, other risk factors in these patients have not been delineated.
  
  
  METHODS
  We examined 20 demographic and clinical variables for their association with the development of CMV disease, as defined by an independent endpoint committee (IEC) and also by the investigator (investigator treated [IT]), or CMV viremia within 12 months of transplant in D+/R- transplant recipients who received prophylaxis with valganciclovir or oral ganciclovir for 100 days.
  
  
  RESULTS
  Recipients with low creatinine clearance (Ccr,<40 mL/min) at screening had a significantly increased hazard of developing IEC-defined CMV disease (hazards ratio [HR]=4.28, confidence interval [CI] 1.69, 10.83). Females were twice as likely (HR=2.19, CI .21, 3.99) to develop IEC-defined CMV disease than males. These variables were associated with an increased risk of IEC-defined CMV disease in time-dependent models. Recipients with blood group A were also more likely to develop IEC-defined CMV disease than those with group O (HR=2.36 CI 1.24, 4.51) in the logistic regression model only. Prophylactic drug, organ type, recipient age, rejection episodes, and maintenance immunosuppression regimen were not associated with IEC-defined CMV disease. Female sex was the only variable associated with the development of CMV viremia (odds ratio [OR]=1.65; CI 1.03, 2.65) and IT CMV disease (OR=1.78; CI 1.08, 2.93).
  
  
  CONCLUSIONS
  Low Ccr at screening and blood type A are risk factors for IEC-defined CMV disease, and female sex was a risk factor for IEC- and IT-defined CMV disease and viremia in high-risk SOT recipients. These variables should perhaps be considered when optimizing treatment.
authors.affiliation: New England Medical Center of Transplant Surgery, Boston, MA. 2 Mayo Clinic, Rochester, MN 02111, USA. RFreeman@tufts-nemc.org
authors.forename: Richard B
authors.initials: RB
authors.lastname: Freeman
authors.forename: Carlos
authors.initials: C
authors.lastname: Paya
authors.forename: Mark D
authors.initials: MD
authors.lastname: Pescovitz
authors.forename: Atul
authors.initials: A
authors.lastname: Humar
authors.forename: Ed
authors.initials: E
authors.lastname: Dominguez
authors.forename: Kenneth
authors.initials: K
authors.lastname: Washburn
authors.forename: Emily
authors.initials: E
authors.lastname: Blumberg
authors.forename: Barbara
authors.initials: B
authors.lastname: Alexander
authors.forename: Nigel
authors.initials: N
authors.lastname: Heaton
mesh_terms: D000017:ABO Blood-Group System; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D003404:Creatinine / Q000378:metabolism; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000209:etiology* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D015774:Ganciclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000009:adverse effects*; D016016:Proportional Hazards Models; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D000077562:Valganciclovir; D014766:Viremia / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D000017:ABO Blood-Group System; D000998:Antiviral Agents; D003404:Creatinine; D000077562:Valganciclovir; D015774:Ganciclovir