title: Randomized trial of valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation.
abstract: OBJECTIVE
  Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus prophylaxis after renal transplantation. A head-to-head comparison of both regimens is lacking. The objective of the study was to compare valacyclovir prophylaxis with valganciclovir, which constituted the control group.
  
  
  METHODS
  In a randomized, open-label, single-center trial, recipients of renal transplants (recipient or donor cytomegalovirus-seropositive) were randomly allocated (1:1) to 3-month prophylaxis with valacyclovir (2 g four times daily) or valganciclovir (900 mg daily). Enrollment occurred from November of 2007 to April of 2012. The primary end points were cytomegalovirus DNAemia and biopsy-proven acute rejection at 12 months. Analysis was by intention to treat.
  
  
  RESULTS
  In total, 119 patients were assigned to valacyclovir (n=59) or valganciclovir prophylaxis (n=60). Cytomegalovirus DNAemia developed in 24 (43%) of 59 patients in the valacyclovir group and 18 (31%) of 60 patients in the valganciclovir group (adjusted hazard ratio, 1.35; 95% confidence interval, 0.71 to 2.54; P=0.36). The incidence of cytomegalovirus disease was 2% with valacyclovir and 5% with valganciclovir prophylaxis (adjusted hazard ratio, 0.21; 95% confidence interval, 0.01 to 5.90; P=0.36). Significantly more patients with valacyclovir prophylaxis developed biopsy-proven acute rejection (18 of 59 [31%] versus 10 of 60 [17%]; adjusted hazard ratio, 2.49; 95% confidence interval, 1.09 to 5.65; P=0.03). The incidence of polyomavirus viremia was higher in the valganciclovir group (18% versus 36%; adjusted hazard ratio, 0.43; 95% confidence interval, 0.19 to 0.96; P=0.04).
  
  
  CONCLUSIONS
  Valganciclovir shows no superior efficacy in cytomegalovirus DNAemia prevention compared with valacyclovir prophylaxis. However, the risk of biopsy-proven acute rejection is higher with valacyclovir.
authors.affiliation: Departments of Internal Medicine I, Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic reischig@fnplzen.cz.
authors.forename: Tomas
authors.initials: T
authors.lastname: Reischig
authors.affiliation: Departments of Internal Medicine I, Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic.
authors.forename: Martin
authors.initials: M
authors.lastname: Kacer
authors.affiliation: Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic Hemato-oncology, and.
authors.forename: Pavel
authors.initials: P
authors.lastname: Jindra
authors.affiliation: Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic Pathology, Charles University Medical School and Teaching Hospital, Pilsen, Czech Republic; and.
authors.forename: Ondrej
authors.initials: O
authors.lastname: Hes
authors.affiliation: Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic Hemato-oncology, and.
authors.forename: Daniel
authors.initials: D
authors.lastname: Lysak
authors.affiliation: Departments of Internal Medicine I, Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic.
authors.forename: Mirko
authors.initials: M
authors.lastname: Bouda
mesh_terms: D000208:Acute Disease; D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D003587:Cytomegalovirus / Q000187:drug effects / Q000235:genetics; D003586:Cytomegalovirus Infections / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D018153:Czech Republic; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006084:Graft Rejection / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D057194:Intention to Treat Analysis; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D000077483:Valacyclovir; D000077562:Valganciclovir; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D007166:Immunosuppressive Agents; D000077562:Valganciclovir; D014633:Valine; D000077483:Valacyclovir; D015774:Ganciclovir; D000212:Acyclovir
keywords: cytomegalovirus; prevention; renal transplantation; valacyclovir; valganciclovir