title: Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life.
abstract: BACKGROUND
  There are no previous data describing nelfinavir and lamivudine pharmacokinetics in neonates treated with weight-band dosing regimens.
  
  
  METHODS
  Pharmacokinetic study of nelfinavir and lamivudine pharmacokinetics in infants during the first 2 weeks of life treated with weight-band dosing regimens.
  
  
  METHODS
  Intensive 12-hour pharmacokinetic profiles were performed between either days 4-7 or days 10-14 of life in 26 Brazilian infants.
  
  
  RESULTS
  Pharmacokinetic data were obtained from 26 infants who received median (range) per kg doses of 58.8 (48.4-79.0) mg/kg for nelfinavir and 2.0 (1.5-3.2) mg/kg for lamivudine. Median nelfinavir 12-hour AUC (AUC0-12) was 25.5 (1.7-183.5) μg*h/mL and median 12-hour concentration (C12h) was 1.09 (<0.04-14.44) μg/mL. AUC0-12 was less than 15 μg*h/mL (the 10% for adults) in 12 infants (46%). Median lamivudine AUC0-12 was 7.8 (2.7-15.6) μg*h/mL and median C12h was 0.23 (<0.04-0.74) μg/mL.
  
  
  CONCLUSIONS
  : Lamivudine pharmacokinetic parameters observed in this study were consistent with those seen in other studies of neonates. While median nelfinavir AUC and C12h in these neonates were above the exposure targets, interindividual variability in nelfinavir exposure was large and nelfinavir exposure failed to meet the exposure targets in 46% of infants.
authors.affiliation: Department of Pediatrics, Boston University School of Medicine, Boston, MA, USA. markm@bu.edu
authors.forename: Mark
authors.initials: M
authors.lastname: Mirochnick
authors.forename: Karin
authors.initials: K
authors.lastname: Nielsen-Saines
authors.forename: Jose Henrique
authors.initials: JH
authors.lastname: Pilotto
authors.forename: Jorge
authors.initials: J
authors.lastname: Pinto
authors.forename: Valdilea Gonçalves
authors.initials: VG
authors.lastname: Veloso
authors.forename: Steven
authors.initials: S
authors.lastname: Rossi
authors.forename: Jack
authors.initials: J
authors.lastname: Moye
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Bryson
authors.forename: Lynne
authors.initials: L
authors.lastname: Mofenson
authors.forename: Margaret
authors.initials: M
authors.lastname: Camarca
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
mesh_terms: D019380:Anti-HIV Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000821:virology; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D019259:Lamivudine / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D008297:Male; D019888:Nelfinavir / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine; D019888:Nelfinavir