title: Nevirapine concentrations in newborns receiving an extended prophylactic regimen.
abstract: BACKGROUND
  The optimal neonatal antiretroviral (ARV) regimen for prevention of HIV mother-to-child transmission (MTCT) is unknown for infants born to mothers who receive no ARVs during pregnancy.
  
  
  METHODS
  As part of a protocol comparing the efficacy of 3 neonatal ARV regimens in preventing HIV-1 MTCT in neonates born to mothers who receive no prenatal treatment with ARVs, we devised a 3-dose nevirapine (NVP) regimen with the goal of maintaining the NVP plasma concentration >100 ng/mL (10 times the in vitro median inhibitory concentration of 10 ng/mL) during the first 2 weeks of life. NVP concentrations were measured in 14 newborns participating in a pharmacokinetics substudy during the second week of life and in single samples from 30 more newborns on day 10 to 14.
  
  
  RESULTS
  The median NVP elimination half-life was 30.2 hours (range: 17.8 to 50.3 hours). The NVP concentration remained greater than the target of 100 ng/mL in all samples collected through day 10 of life. By day 14, more than half of the newborns in the pharmacokinetic substudy had NVP levels <100 ng/mL, although only 1 neonate had no detectable NVP.
  
  
  CONCLUSIONS
  Although this regimen failed to meet our 100-ng/mL target, it did maintain detectable NVP concentrations in nearly all newborns through the end of the second week of life and is to be used in the parent efficacy protocol.
authors.affiliation: Department of Pediatrics, Boston University School of Medicine, Boston, MA 02118, 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: Eleanor
authors.initials: E
authors.lastname: Jiménez
authors.forename: Valdilea G
authors.initials: VG
authors.lastname: Veloso
authors.forename: Teresa
authors.initials: T
authors.lastname: Parsons
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
authors.forename: Jack
authors.initials: J
authors.lastname: Moye
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.forename: Margaret
authors.initials: M
authors.lastname: Camarca
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Bryson
mesh_terms: D019380:Anti-HIV Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D002851:Chromatography, High Pressure Liquid; D004305:Dose-Response Relationship, Drug; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019829:Nevirapine / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine