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Developmental pharmacokinetic changes of Lamivudine in infants and children.

Publication ,  Journal Article
Tremoulet, AH; Nikanjam, M; Cressey, TR; Chokephaibulkit, K; McKinney, R; Mirochnick, M; Capparelli, EV
Published in: J Clin Pharmacol
December 2012

Lamivudine is a nucleoside reverse transcriptase inhibitor widely used in infants and children in combination antiretroviral therapy to treat human immunodeficiency virus (HIV) infection. Developmental changes in lamivudine pharmacokinetic disposition were assessed by combining data from 7 studies of lamivudine (Pediatric AIDS Clinical Trials Group 300, 353, 356, 358, 386, 1056, and 1069) representing subjects across the pediatric age continuum. A population pharmacokinetic model was developed to identify factors that influence lamivudine disposition. Age and Thai race were independent predictors of apparent clearance (CL/F), whereas the use of a fixed drug combination formulation (GPO-VIR) was an independent predictor of bioavailability, with CL/F more than doubling from birth to adolescence. Serum creatinine was not associated with CL/F. Monte Carlo simulations were used to compare the lamivudine exposure achieved with World Health Organization (WHO) weight band and Food and Drug Administration (FDA) label dosing recommendations. WHO dosing yielded higher exposure during the first few months of life, but this difference was less pronounced between 6 months and 14 years of age. Overall, both FDA and WHO dosing provided similar AUC values to those previously reported in HIV-infected adults. Lamivudine WHO weight band dosing results in therapeutic exposure in infants and children and may improve drug dosing in resource-limited countries.

Duke Scholars

Published In

J Clin Pharmacol

DOI

EISSN

1552-4604

Publication Date

December 2012

Volume

52

Issue

12

Start / End Page

1824 / 1832

Location

England

Related Subject Headings

  • Reverse Transcriptase Inhibitors
  • Pharmacology & Pharmacy
  • Models, Biological
  • Lamivudine
  • Infant, Newborn
  • Infant
  • Humans
  • HIV Infections
  • Creatinine
  • Child, Preschool
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Tremoulet, A. H., Nikanjam, M., Cressey, T. R., Chokephaibulkit, K., McKinney, R., Mirochnick, M., & Capparelli, E. V. (2012). Developmental pharmacokinetic changes of Lamivudine in infants and children. J Clin Pharmacol, 52(12), 1824–1832. https://doi.org/10.1177/0091270011426563
Tremoulet, Adriana H., Mina Nikanjam, Tim R. Cressey, Kulkanya Chokephaibulkit, Ross McKinney, Mark Mirochnick, and Edmund V. Capparelli. “Developmental pharmacokinetic changes of Lamivudine in infants and children.J Clin Pharmacol 52, no. 12 (December 2012): 1824–32. https://doi.org/10.1177/0091270011426563.
Tremoulet AH, Nikanjam M, Cressey TR, Chokephaibulkit K, McKinney R, Mirochnick M, et al. Developmental pharmacokinetic changes of Lamivudine in infants and children. J Clin Pharmacol. 2012 Dec;52(12):1824–32.
Tremoulet, Adriana H., et al. “Developmental pharmacokinetic changes of Lamivudine in infants and children.J Clin Pharmacol, vol. 52, no. 12, Dec. 2012, pp. 1824–32. Pubmed, doi:10.1177/0091270011426563.
Tremoulet AH, Nikanjam M, Cressey TR, Chokephaibulkit K, McKinney R, Mirochnick M, Capparelli EV. Developmental pharmacokinetic changes of Lamivudine in infants and children. J Clin Pharmacol. 2012 Dec;52(12):1824–1832.

Published In

J Clin Pharmacol

DOI

EISSN

1552-4604

Publication Date

December 2012

Volume

52

Issue

12

Start / End Page

1824 / 1832

Location

England

Related Subject Headings

  • Reverse Transcriptase Inhibitors
  • Pharmacology & Pharmacy
  • Models, Biological
  • Lamivudine
  • Infant, Newborn
  • Infant
  • Humans
  • HIV Infections
  • Creatinine
  • Child, Preschool