1. ¹Division of Clinical Pharmacology, The University of Alabama at Birmingham, Birmingham, Alabama, USA
2. ²Department of Experimental and Clinical Pharmacology, The University of Minnesota, Minneapolis, Minnesota, USA
3. ³Department of Pediatrics, University of Texas Southwestern, Dallas, Texas, USA
4. ⁴Schneider Children's Hospital, New York, New York, USA
5. ⁵Stroger Hospital, Cook County, Illinois, USA
6. ⁶University of Southern California, Los Angeles, California, USA
7. ⁷Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
8. ⁸Children's Hospital of Orange County, Orange County, California, USA
9. ⁹University of Nebraska Medical Center and Creighton University, Omaha, Nebraska, USA
10. ¹⁰Division of Pediatric Infectious Diseases, Department of Pediatrics, The University of Alabama at Birmingham, Birmingham, Alabama, USA
11. ¹¹Medical Statistics Section, Department of Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA

Correspondence: EP Acosta, (eacosta@uab.edu)

Received 7 November 2006; Accepted 27 January 2007; Published online 28 March 2007.

Abstract

Cytomegalovirus (CMV) is the most common viral congenital infection, producing both sensorineural hearing loss and mental retardation. Our objective was to assess the population pharmacokinetics of a research-grade oral valganciclovir solution in neonates with symptomatic congenital CMV disease. Twenty-four neonates received 6 weeks of antiviral therapy. Ganciclovir and valganciclovir were measured by liquid chromatography/tandem mass spectroscopy. NONMEM version VI beta was used for population analyses. All profiles were consistent with a one-compartment model. Postnatal age, body surface area, and gender did not improve the model fit after body weight was taken into account. The typical value of clearance (l/h), distribution volume (l), and bioavailability of ganciclovir were 0.146 body weight (WT)^1.68, 1.15 WT, and 53.6%, respectively. Although these results cannot be extrapolated to extemporaneously compounded valganciclovir preparations, they provide the foundation on which a commercial-grade valganciclovir oral solution may be a viable option for administration to neonates.