title: Effects of oral valganciclovir prophylaxis for cytomegalovirus infection in heart transplant patients.
abstract: BACKGROUND
  Cytomegalovirus (CMV) infection is a serious complication following heart transplantation. This study (June 2003-January 2010) retrospectively assessed the effects of oral valganciclovir prophylaxis in adult heart transplant recipients during the first year after transplantation.
  
  
  METHODS
  In patients with normal renal function, 900 mg of oral valganciclovir was administered twice daily for 14 days after heart transplant followed by 900 mg per day for following 6 months. In the event of renal insufficiency, valganciclovir was adjusted according to the manufacturer's recommendations. Antigenemia testing for pp65 antigen and simultaneous polymerase chain reaction (PCR) were used to document exposure to CMV. From 2003 to 2010, 146 patients (74.0% men) of mean age 50.7 ± 10.3 years at the time of heart transplant were included.
  
  
  RESULTS
  A total of 16 patients (11.0% of total, 75.0% male) had a positive pp65 and PCR result (ie, CMV infection) during the year following heart transplant; three of these patients had discontinued valganciclovir prophylaxis within the first 6 months following transplant because of leukopenia, including one patient developed CMV colitis. Two further patients developed CMV pneumonia during prophylactic valganciclovir therapy. Eight patients had positive pp65 and PCR tests in the 6-12 months after heart transplant following cessation of routine prophylaxis. One of these patients developed CMV pneumonia and another developed CMV colitis and CMV pneumonia. Thirty-seven of the 146 (25.3%) patients were CMV donor-seropositive/recipient-seronegative, and seven (18.9% of this subgroup) had a positive CMV test. In patients who were CMV donor-seropositive/recipient-seronegative, the risk of a positive CMV test (ie, CMV infection) was significantly elevated (P = 0.023).
  
  
  CONCLUSIONS
  CMV prophylaxis with oral valganciclovir for 6 months following heart transplant is clinically feasible. In line with previous studies, CMV donor-seropositive/recipient-seronegative patients have a significantly elevated risk of CMV infection. In patients who prematurely discontinue valganciclovir, close monitoring of CMV antigenemia appears warranted. No significantly elevated rate of CMV infection was observed after 6 months of valganciclovir prophylaxis.
authors.affiliation: Department of Cardiology, University of Heidelberg, Heidelberg. andreas.doesch@med.uni-heidelberg.de
authors.forename: Andreas O
authors.initials: AO
authors.lastname: Doesch
authors.forename: Janika
authors.initials: J
authors.lastname: Repp
authors.forename: Nina
authors.initials: N
authors.lastname: Hofmann
authors.forename: Christian
authors.initials: C
authors.lastname: Erbel
authors.forename: Lutz
authors.initials: L
authors.lastname: Frankenstein
authors.forename: Christian A
authors.initials: CA
authors.lastname: Gleissner
authors.forename: Constanze
authors.initials: C
authors.lastname: Schmidt
authors.forename: Arjang
authors.initials: A
authors.lastname: Ruhparwar
authors.forename: Christian
authors.initials: C
authors.lastname: Zugck
authors.forename: Paul
authors.initials: P
authors.lastname: Schnitzler
authors.forename: Philipp
authors.initials: P
authors.lastname: Ehlermann
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Dengler
authors.forename: Hugo A
authors.initials: HA
authors.lastname: Katus
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006084:Graft Rejection; D016027:Heart Transplantation / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir
keywords: cytomegalovirus infection; heart transplantation; valganciclovir prophylaxis