title: Cytomegalovirus antigenemia directed pre-emptive prophylaxis with oral versus I.V. ganciclovir for the prevention of cytomegalovirus disease in liver transplant recipients: a randomized, controlled trial.
abstract: BACKGROUND
  The efficacy of pre-emptively administered oral ganciclovir in preventing cytomegalovirus (CMV) disease has not been documented in liver transplant recipients. We sought to compare the efficacy of pre-emptive oral ganciclovir with that of i.v. ganciclovir for the prevention of CMV disease after liver transplantation, and to determine whether withholding prophylaxis in the absence of CMV antigenemia, reliably identified patients in whom no prophylaxis was necessary.
  
  
  METHODS
  Surveillance cultures for CMV pp65 antigenemia were performed in all patients at weeks 2, 4, 6, 8, 12, and 16. Patients with CMV antigenemia were randomized into two study groups. The experimental group received oral ganciclovir for 6 weeks (2 g t.i.d. for 2 weeks, then 1 g t.i.d. for 4 weeks), and the control group received i.v. ganciclovir (5 mg/kg q 12 hr) for 7 days.
  
  
  RESULTS
  Of 72 consecutive liver transplant recipients studied, CMV antigenemia occurred in 31% (22 of 72). Twenty-two patients with asymptomatic antigenemia were randomized to two study groups. CMV disease (viral syndrome) occurred in 9% (1 of 11) of the patients in the i.v. ganciclovir group and in 0% (0 of 11) of the patients in the oral ganciclovir group. None of the study patients developed tissue invasive CMV disease. The median reduction in antigenemia level with oral ganciclovir was 55% at week 1, and 100% at week 2. Overall, 64% of the patients by week 1, 93% by week 2, and 100% by week 4 had antigenemia levels below the baseline after oral ganciclovir. Of 50 patients without CMV antigenemia, none developed CMV disease.
  
  
  CONCLUSIONS
  Pre-emptive prophylaxis based on CMV antigenemia can effectively target the patients for CMV prophylaxis; 69% of the patients never received antiviral prophylaxis and did not develop CMV disease. Antiviral therapy instituted upon detection of antigenemia prevented tissue invasive CMV in both ganciclovir groups. Pre-emptively administered oral ganciclovir was effective as prophylaxis for CMV disease after liver transplantation.
authors.affiliation: Veterans Affairs Medical Center and University of Pittsburgh, Thomas E. Starzl Transplantation Institute, Pennsylvania 15240, USA. nis5+@pitt.edu
authors.forename: N
authors.initials: N
authors.lastname: Singh
authors.forename: D L
authors.initials: DL
authors.lastname: Paterson
authors.forename: T
authors.initials: T
authors.lastname: Gayowski
authors.forename: M M
authors.initials: MM
authors.lastname: Wagener
authors.forename: I R
authors.initials: IR
authors.lastname: Marino
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000956:Antigens, Viral / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics; D002648:Child; D002675:Child, Preschool; D003365:Costs and Cost Analysis; D003587:Cytomegalovirus / Q000276:immunology*; D003586:Cytomegalovirus Infections / Q000209:etiology / Q000517:prevention & control*; D015774:Ganciclovir / Q000008:administration & dosage* / Q000191:economics; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D016031:Liver Transplantation / Q000009:adverse effects*; D008875:Middle Aged; D013997:Time Factors
chemical_list: D000956:Antigens, Viral; D000998:Antiviral Agents; D015774:Ganciclovir