Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Wiltshire, H; Paya, CV; Pescovitz, MD; Humar, A; Dominguez, E; Washburn, K; Blumberg, E; Alexander, B; Freeman, R; Heaton, N; Zuideveld, KP; Valganciclovir Solid Organ Transplant Study Group,

Published Date

  • June 15, 2005

Published In

Volume / Issue

  • 79 / 11

Start / End Page

  • 1477 - 1483

PubMed ID

  • 15940035

International Standard Serial Number (ISSN)

  • 0041-1337

Digital Object Identifier (DOI)

  • 10.1097/


  • eng

Conference Location

  • United States