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

Publication ,  Journal Article
Wiltshire, H; Paya, CV; Pescovitz, MD; Humar, A; Dominguez, E; Washburn, K; Blumberg, E; Alexander, B; Freeman, R; Heaton, N; Zuideveld, KP ...
Published in: Transplantation
June 15, 2005

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.

Duke Scholars

Published In

Transplantation

DOI

ISSN

0041-1337

Publication Date

June 15, 2005

Volume

79

Issue

11

Start / End Page

1477 / 1483

Location

United States

Related Subject Headings

  • Viremia
  • Viral Load
  • Valganciclovir
  • Surgery
  • Postoperative Complications
  • Organ Transplantation
  • Middle Aged
  • Male
  • Humans
  • Ganciclovir
 

Citation

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Wiltshire, H., Paya, C. V., Pescovitz, M. D., Humar, A., Dominguez, E., Washburn, K., … Valganciclovir Solid Organ Transplant Study Group, . (2005). Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients. Transplantation, 79(11), 1477–1483. https://doi.org/10.1097/01.tp.0000164512.99703.ad
Wiltshire, Hugh, Carlos V. Paya, Mark D. Pescovitz, Atul Humar, Edward Dominguez, Kenneth Washburn, Emily Blumberg, et al. “Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients.Transplantation 79, no. 11 (June 15, 2005): 1477–83. https://doi.org/10.1097/01.tp.0000164512.99703.ad.
Wiltshire H, Paya CV, Pescovitz MD, Humar A, Dominguez E, Washburn K, et al. Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients. Transplantation. 2005 Jun 15;79(11):1477–83.
Wiltshire, Hugh, et al. “Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients.Transplantation, vol. 79, no. 11, June 2005, pp. 1477–83. Pubmed, doi:10.1097/01.tp.0000164512.99703.ad.
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. Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients. Transplantation. 2005 Jun 15;79(11):1477–1483.

Published In

Transplantation

DOI

ISSN

0041-1337

Publication Date

June 15, 2005

Volume

79

Issue

11

Start / End Page

1477 / 1483

Location

United States

Related Subject Headings

  • Viremia
  • Viral Load
  • Valganciclovir
  • Surgery
  • Postoperative Complications
  • Organ Transplantation
  • Middle Aged
  • Male
  • Humans
  • Ganciclovir