Abstract | BACKGROUND:
Valacyclovir provides enhanced acyclovir bioavailability in adults, but limited data are available in children. METHODS: RESULTS: Dose proportionality in the maximum observed concentration (C(max)) of acyclovir and the area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-infinity)) existed across the 10 to 20 mg/kg valacyclovir dose range. For children 2 through 5 years of age, an increase in dose from 20 to 25 mg/kg resulted in near doubling of the C(max) and AUC(0-infinity). Among infants 1 through 2 months of age receiving 25 mg/kg, the mean AUC(0-infinity) and C(max) were higher ( approximately 60% and 30%, respectively) than those among older infants and children receiving the same dose. Valacyclovir oral suspension was well tolerated. No clinically significant trends were noted in clinical chemical, hematologic, or urinalysis values from screening to follow-up. CONCLUSIONS: Among children 3 months through 11 years of age, the 20 mg/kg dose of this formulation of valacyclovir oral suspension produces favorable acyclovir blood concentrations and is well tolerated. A dosing recommendation cannot be made for infants <3 months of age because of decreased clearance in this age group. Trial registration. ClinicalTrials.gov identifier: NCT00297206 .
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Authors | David W Kimberlin, Richard F Jacobs, Stephen Weller, Jan-Stefan van der Walt, Catherine K Heitman, Choy Y Man, John S Bradley |
Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
(Clin Infect Dis)
Vol. 50
Issue 2
Pg. 221-8
(Jan 15 2010)
ISSN: 1537-6591 [Electronic] United States |
PMID | 20014952
(Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- Suspensions
- Valine
- Valacyclovir
- Acyclovir
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Topics |
- Acyclovir
(analogs & derivatives, pharmacokinetics, therapeutic use)
- Administration, Oral
- Antiviral Agents
(pharmacokinetics, therapeutic use)
- Child
- Child, Preschool
- Female
- Herpesviridae Infections
(drug therapy)
- Humans
- Infant
- Male
- Suspensions
- Valacyclovir
- Valine
(analogs & derivatives, pharmacokinetics, therapeutic use)
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