• E P Acosta, R C Brundage, J R King, P J Sánchez, S Sood, V Agrawal, J Homans, R F Jacobs, D Lang, J R Romero, J Griffin, G Cloud, R Whitley, D W Kimberlin, and National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group.
• Division of Clinical Pharmacology, The University of Alabama at Birmingham, Birmingham, Alabama, USA. eacosta@uab.edu
• Clin. Pharmacol. Ther. 2007 Jun 1; 81 (6): 867-72.

AbstractCytomegalovirus (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 x body weight (WT)(1.68), 1.15 x 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.

28 keywords...

hide…