Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients

Transplantation. 2005 Jun 15;79(11):1477-83. doi: 10.1097/


Background: A randomized, double-blind study was conducted to evaluate the pharmacokinetics of ganciclovir following oral administration of ganciclovir or valganciclovir for prophylaxis of cytomegalovirus (CMV) disease in solid organ transplant recipients (n = 240/372).

Methods: The correlations between individual exposure to ganciclovir during prophylaxis, with CMV viremia incidence during and after treatment, CMV disease up to 12 months posttransplant, and hematological toxicity were assessed.

Results: Mean daily areas under the curve (AUCs) of ganciclovir from valganciclovir and oral ganciclovir were 46.3 +/- 15.2 and 28.0 +/- 10.9 microg.h/ml (mean +/- SD), respectively. Viremia was suppressed during prophylaxis when exposure to ganciclovir was 40-50 microg.h/ml, AUCs typical of those achieved in valganciclovir-treated patients. The development of viremia 1 month after ending prophylaxis was also reduced with higher ganciclovir AUC (median predicted incidence, 20% and 10% at AUCs of 33 and 50 microg h/ml, respectively). The development of CMV disease within 1 year of transplant was 17.6% and independent of prophylactic exposure to ganciclovir. There was only a weak tendency to increased neutropenia and leukopenia with higher ganciclovir exposure.

Conclusions: The greater systemic exposure to ganciclovir delivered by valganciclovir was associated with delayed development of viremia. There was only a weak association between AUC and hematological toxicity.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / pharmacokinetics*
  • Antiviral Agents / therapeutic use
  • Area Under Curve
  • Body Height
  • Body Weight
  • Cytomegalovirus / isolation & purification
  • Cytomegalovirus Infections / prevention & control*
  • Double-Blind Method
  • Female
  • Ganciclovir / administration & dosage
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / pharmacokinetics*
  • Ganciclovir / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Organ Transplantation*
  • Postoperative Complications / virology*
  • Valganciclovir
  • Viral Load
  • Viremia / epidemiology


  • Antiviral Agents
  • Valganciclovir
  • Ganciclovir