Nevirapine concentrations in newborns receiving an extended prophylactic regimen

Mark Mirochnick, Karin Nielsen-Saines, Jose Henrique Pilotto, Jorge Pinto, Eleanor Jiménez, Valdilea G. Veloso, Teresa Parsons, D. Heather Watts, Jack Moye, Lynne M. Mofenson, Margaret Camarca, Yvonne Bryson, Mariza Morgado, Eunice Yu, James Bethel, Elizabeth Hawkins, Elizabeth Smith, Sheryl Zwerski, Marita D. McDonough, Charles T. LancasterCristina PharoRuth, Ruth E. Dickover

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


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. CONCLUSION: 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.

Original languageEnglish (US)
Pages (from-to)334-337
Number of pages4
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number3
StatePublished - Mar 2008
Externally publishedYes


  • Mother-to-child HIV transmission
  • Neonate
  • Nevirapine
  • Pharmacokinetics

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)


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