Age-related differences in the pharmacokinetics of stavudine in 272 children from birth to 16 years: a population analysis

doi:10.1111/j.1365-2125.2007.02854.x

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Wiley InterScience

British Journal of Clinical Pharmacology

Volume 64 Issue 1, Pages 105 - 109

Published Online: 26 Feb 2007

The Journal of The British Pharmacological Society

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Age-related differences in the pharmacokinetics of stavudine in 272 children from birth to 16 years: a population analysis

V. Jullien, ^1,2,3,5,10 A. Raïs, ^1,2,3,5 S. Urien, ^7,10 J. Dimet, ⁹ C. Delaugerre, ^1,2,4,8 M. Bouillon-Pichault, ^1,3,5,10 E. Rey, ^1,2,3,5,10 G. Pons, ^1,2,3,5,10 S. Blanche, ^1,2,4,6,10 & J. M. Tréluyer, ^1,2,3,5,10

¹ Université Paris Descartes-Faculté de Médecine, ² Assistance Publique-Hôpitaux de Paris, ³ Groupe Hospitalier Cochin-Saint-Vincent-de-Paul, ⁴ Hôpital Necker-Enfants Malades, ⁵ Pharmacologie Clinique, ⁶ Unité d'Immunologie Pédiatrique, ⁷ Service de Pharmacologie Clinique-Centre Hospitalier René Huguenin, ⁸ Virologie, ⁹ Unité de Recherche Clinique La Roche-sur-Yon, ¹⁰ EA 3620, France

Correspondence to Vincent Jullien, Service de Pharmacologie Clinique, Groupe Hospitalier Cochin-Saint-Vincent de Paul, 74–82 avenue Denfert-Rochereau, 75674 Paris Cedex 14. France.
Tel.: + 33 1 4048 8209
Fax: + 33 1 4048 8223
E-mail: vincent.jullien@svp.aphp.fr

KEYWORDS

children • HIV • pharmacokinetics • stavudine

ABSTRACT

Aims

To develop a population pharmacokinetic model for stavudine in children and to investigate the consistency of the currently recommended dose based on adult target concentrations.

Methods

The pharmacokinetics of stavudine were investigated using a population approach. Individual estimates of CL/F were used to calculate the stavudine dose required to achieve the area under the concentration-time curve reported in adults given recommended doses.

Results

Stavudine pharmacokinetics were well described by a one-compartment model with zero-order absorption. Typical population estimates (% interindividual variability) of the apparent distribution volume (V/F) and plasma clearance (CL/F) were 40.9 l (32%) and 16.5 l h⁻¹ (38%), respectively. Stavudine V/F and CL/F were similarly related to age. Mean calculated doses (0.61 mg kg⁻¹ for children less than 2 weeks, 1.23 mg kg⁻¹ for children more than 2 weeks with bodyweight less than 30 kg, and 31.5 mg for children with a bodyweight between 30 and 60 kg) were in agreement with the current paediatric doses (0.5 mg kg⁻¹, 1 mg kg⁻¹, and 30 mg, respectively).