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Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life

Mark Mirochnick1, Karin Nielsen-Saines, Jose Henrique Pilotto

  • 1Department of Pediatrics, Boston University School of Medicine, Boston, MA, USA. markm@bu.edu

The Pediatric Infectious Disease Journal
|June 14, 2011
PubMed

Insights

This study evaluated nelfinavir and lamivudine pharmacokinetics in neonates using weight-band dosing. While lamivudine levels were consistent, nelfinavir exposure varied significantly, with nearly half of infants not reaching target levels.

Area of Science:

  • Neonatal pharmacology
  • Pediatric pharmacokinetics
  • Antiviral drug metabolism

Background:

  • Limited pharmacokinetic data exists for nelfinavir and lamivudine in neonates on weight-band dosing.
  • This study addresses a critical knowledge gap in neonatal drug therapy.

Purpose of the Study:

  • To characterize the pharmacokinetics of nelfinavir and lamivudine in neonates.
  • To assess the adequacy of weight-band dosing regimens for these drugs in the neonatal population.

Main Methods:

  • A pharmacokinetic study was conducted in 26 Brazilian infants within the first two weeks of life.
  • Intensive 12-hour pharmacokinetic profiles were obtained between days 4-7 or 10-14 of life.

Main Results:

  • Median nelfinavir AUC0-12 was 25.5 microg*h/mL, with 46% of infants below adult exposure targets.
  • Median lamivudine AUC0-12 was 7.8 microg*h/mL, showing consistency with previous neonatal studies.
  • Significant inter-individual variability was observed in nelfinavir exposure.

Conclusions:

  • Lamivudine pharmacokinetics in neonates were consistent with existing data.
  • Nelfinavir exposure in neonates exhibited high variability and frequently failed to meet therapeutic targets.
  • Weight-band dosing may require adjustments for nelfinavir to ensure adequate exposure in neonates.
Abstract

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