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Antimicrob. Agents Chemother. doi:10.1128/AAC.00943-05
Copyright (c) 2006, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Weight, age, and sex-related differences in the pharmacokinetics of lopinavir in children from birth to 18 years: a population analysis

Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Pharmacologie Clinique, Gynécologie-Obstétrique 1, Groupe Hospitalier Cochin-Saint-Vincent de Paul, INSERM, Virologie, Unité d'Immunologie-Hématologie Pédiatrique, Groupe Hospitalier Necker-Enfants Malades, Centre René-Huguenin Saint-Cloud, EA3620

^* To whom correspondence should be addressed. Email: vincent.jullien{at}svp.aphp.fr,

	Abstract

The pharmacokinetics of lopinavir was investigated, by the use of a population approach performed with the non linear mixed effect modeling program NONMEM, in 157 children ranging in age from 3 days to 18 years. Lopinavir pharmacokinetics was well described by a one-compartment model in which the absorption and the elimination rate constants are equal. Typical population estimates of apparent distribution volume (V/F) and plasma clearance (CL/F) were 24.6 liters and 2.58 liter/h respectively. Lopinavir V/F and CL/F were both related to bodyweight (BW), with an important increase in weight-normalized CL/F for the lowest BW. Combined treatment with nevirapine was found to increase CL/F. Lopinavir CL/F was also age and sex-related as a 39 % increase was observed after the age of 12 years for boys compared to girls. The consequences of these pharmacokinetics discrepancies and the necessity to modify the current recommended dosage regimen should be further investigated.

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