Document Detail


Evaluation of nevirapine dosing recommendations in HIV-infected children.
MedLine Citation:
PMID:  23278548     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: Nevirapine (NVP) is a non-nucleoside reverse transcriptase inhibitor used for chronic human immunodeficiency virus infections in adults and children. The aims of this study were to investigate the population pharmacokinetics of NVP in children, establish factors that influence NVP pharmacokinetics and evaluate the current dosing recommendations.
METHODS: Concentrations were measured on a routine basis in 94 children aged from 2 months to 17 years. A total of 390 NVP plasma concentrations were retrospectively collected, and a population pharmacokinetic model was developed with Monolix 4.0.
RESULTS: Nevirapine pharmacokinetics was best described by a one-compartment model with first-order absorption and elimination. After standardization to a 70 kg adult using allometry, postmenstrual age had a significant effect on the bioavailability. Estimates of apparent clearance and volume of distribution were 3.9 l h(-1) (70 kg)(-1) and 140 l (70 kg)(-1) , respectively. Based on simulations of European Medicines Agency (EMA) and World Health Organization (WHO) dosing recommendations, the probability of observing minimal concentrations below the efficacy target of 3 mg l(-1) is higher following the EMA recommendations than the WHO recommendations. However, NVP underdosing persists for the 3-6 and 6-10 kg weight ranges following the WHO recommendations.
CONCLUSIONS: It is suggested to increase doses to 75 and 100 mg twice daily for the 3-6 and 6-10 kg weight ranges, respectively, in order to obtain more than 95% of children with concentrations above 3 mg l(-1) .
Authors:
Frantz Foissac; Naïm Bouazza; Pierre Frange; Stéphane Blanche; Albert Faye; Eric Lachassinne; Catherine Dollfus; Déborah Hirt; Sihem Benaboud; Jean-Marc Treluyer; Saïk Urien
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  76     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-20     Completed Date:  2014-02-03     Revised Date:  2014-07-01    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  137-44     Citation Subset:  IM    
Copyright Information:
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Age Factors
Anti-HIV Agents / administration & dosage,  pharmacokinetics*
Child
Child, Preschool
Dose-Response Relationship, Drug
Female
HIV Infections / drug therapy*
Humans
Infant
Male
Models, Biological*
Nevirapine / administration & dosage,  pharmacokinetics*
Retrospective Studies
Tissue Distribution
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 99DK7FVK1H/Nevirapine
Comments/Corrections

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