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

Clin Pharmacol Ther. 2007 Jun;81(6):867-72. doi: 10.1038/sj.clpt.6100150. Epub 2007 Mar 28.


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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antiviral Agents / blood
  • Antiviral Agents / pharmacokinetics*
  • Antiviral Agents / therapeutic use
  • Area Under Curve
  • Body Weight
  • Chromatography, High Pressure Liquid
  • Cytomegalovirus Infections / drug therapy*
  • Female
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / blood
  • Ganciclovir / pharmacokinetics*
  • Ganciclovir / therapeutic use
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Newborn, Diseases / drug therapy
  • Injections, Intravenous
  • Male
  • Tandem Mass Spectrometry
  • Valganciclovir


  • Antiviral Agents
  • Valganciclovir
  • Ganciclovir