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Antimicrobial Agents and Chemotherapy, November 2009, p. 4816-4824, Vol. 53, No. 11
0066-4804/09/$08.00+0     doi:10.1128/AAC.00085-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Population Pharmacokinetics of Ganciclovir after Intravenous Ganciclovir and Oral Valganciclovir Administration in Solid Organ Transplant Patients Infected with Cytomegalovirus{triangledown}

A. Caldés,1 H. Colom,2* Y. Armendariz,1 M. J. Garrido,3 I. F. Troconiz,3 S. Gil-Vernet,1 N. Lloberas,1 L. Pou,4 C. Peraire,2 and J. M. Grinyó1

Nephrology Service, Hospital Universitari de Bellvitge, Barcelona, Spain,1 Department of Biopharmaceutics and Pharmacokinetics, School of Pharmacy, University of Barcelona, Barcelona, Spain,2 Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Navarra, Pamplona, Spain,3 Biochemistry Service, Hospital Vall D'Hebron, Barcelona, Spain4

Received 21 January 2009/ Returned for modification 8 July 2009/ Accepted 1 September 2009

A population pharmacokinetics analysis was performed after intravenous ganciclovir and oral valganciclovir in solid organ transplant patients with cytomegalovirus. Patients received ganciclovir at 5 mg/kg of body weight (5 days) and then 900 mg of valganciclovir (16 days), both twice daily with dose adjustment for renal function. A total of 382 serum concentrations from days 5 and 15 were analyzed with NONMEM VI. Renal function given by creatinine clearance (CLCR) was the most influential covariate in CL. The final pharmacokinetic parameters were as follows: ganciclovir clearance (CL) was 7.49·(CLCR/57) liter/h (57 was the mean population value of CLCR); the central and peripheral distribution volumes were 31.9 liters and 32.0 liters, respectively; intercompartmental clearance was 10.2 liter/h; the first-order absorption rate constant was 0.895 h–1; bioavailability was 0.825; and lag time was 0.382 h. The CLCR was the best predictor of CL, making dose adjustment by this covariate important to achieve the most efficacious ganciclovir exposure.

* Corresponding author. Mailing address: Department of Biopharmaceutics and Pharmacokinetics, School of Pharmacy, University of Barcelona, Avda. Joan XXIII, s/n 08028 Barcelona, Spain. Phone: 34-93-4024560. Fax: 34-93-4024563. E-mail: helena.colom{at}ub.edu

{triangledown} Published ahead of print on 8 September 2009.

Antimicrobial Agents and Chemotherapy, November 2009, p. 4816-4824, Vol. 53, No. 11
0066-4804/09/$08.00+0     doi:10.1128/AAC.00085-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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