title: Preemptive use of oral ganciclovir to prevent cytomegalovirus infection in liver transplant patients: a randomized, placebo-controlled trial.
abstract: The use of postdetection antiviral treatment of cytomegalovirus (CMV) as a strategy to prevent infection and disease in solid-organ transplant patients has not been evaluated by placebo-controlled trials. We carried out such a study in 69 patients who had received liver transplants and had positive results of CMV polymerase chain reaction within 8 weeks after transplantation but did not have concomitant CMV infection or disease. These patients were randomly assigned to receive placebo or oral ganciclovir for 8 weeks. CMV infection developed in 21% and disease developed in 12% of placebo recipients (P =.022), compared with 3% and 0%, respectively, among ganciclovir recipients (P =.003). Similarly, in the placebo arm, 55% and 36% of CMV-negative patients who received organs from CMV-positive donors developed CMV infection or disease, respectively (P =.02), compared with 11% and 0% of such patients in the ganciclovir arm (P <.01). Oral ganciclovir administered on CMV detection by PCR prevents CMV infection or disease after liver transplantation.
authors.affiliation: Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota 55905, USA. paya@mayo.edu
authors.forename: Carlos V
authors.initials: CV
authors.lastname: Paya
authors.forename: Jennie A
authors.initials: JA
authors.lastname: Wilson
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Espy
authors.forename: Irene G
authors.initials: IG
authors.lastname: Sia
authors.forename: Michael J
authors.initials: MJ
authors.lastname: DeBernardi
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Smith
authors.forename: Robin
authors.initials: R
authors.lastname: Patel
authors.forename: Greg
authors.initials: G
authors.lastname: Jenkins
authors.forename: William S
authors.initials: WS
authors.lastname: Harmsen
authors.forename: David J
authors.initials: DJ
authors.lastname: Vanness
authors.forename: Russell H
authors.initials: RH
authors.lastname: Wiesner
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D003587:Cytomegalovirus / Q000235:genetics / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage*; D006801:Humans; D016031:Liver Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D015774:Ganciclovir