Ganciclovir population pharmacokinetics in neonates following intravenous administration of ganciclovir and oral administration of a liquid valganciclovir formulation

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

Research output: Contribution to journalArticle

66 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)867-872
Number of pages6
JournalClinical pharmacology and therapeutics
Volume81
Issue number6
DOIs
StatePublished - Jun 2007

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Acosta, E. P., Brundage, R. C., King, J. R., Sánchez, P. J., Sood, S., Agrawal, V., Homans, J., Jacobs, R. F., Lang, D., Romero, J. R., Griffin, J., Cloud, G., Whitley, R., & Kimberlin, D. W. (2007). Ganciclovir population pharmacokinetics in neonates following intravenous administration of ganciclovir and oral administration of a liquid valganciclovir formulation. Clinical pharmacology and therapeutics, 81(6), 867-872. https://doi.org/10.1038/sj.clpt.6100150