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著者: 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, National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
雑誌名: Clin Pharmacol Ther. 2007 Jun;81(6):867-72. doi: 10.1038/sj.clpt.6100150. Epub 2007 Mar 28.
Abstract/Text
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 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.
PMID 17392728 Clin Pharmacol Ther. 2007 Jun;81(6):867-72. doi: 10.1038/sj.clpt.6100150. Epub 2007 Mar 28.
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