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 journalArticle

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

Original languageEnglish (US)
Pages (from-to)334-337
Number of pages4
JournalJournal of Acquired Immune Deficiency Syndromes
Volume47
Issue number3
DOIs
StatePublished - Mar 2008

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Nevirapine
Newborn Infant
Mothers
Pharmacokinetics
Half-Life
HIV-1
HIV
Pregnancy

Keywords

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

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Mirochnick, M., Nielsen-Saines, K., Pilotto, J. H., Pinto, J., Jiménez, E., Veloso, V. G., ... Dickover, R. E. (2008). Nevirapine concentrations in newborns receiving an extended prophylactic regimen. Journal of Acquired Immune Deficiency Syndromes, 47(3), 334-337. https://doi.org/10.1097/QAI.0b013e31815f3c23

Nevirapine concentrations in newborns receiving an extended prophylactic regimen. / Mirochnick, Mark; Nielsen-Saines, Karin; Pilotto, Jose Henrique; Pinto, Jorge; Jiménez, Eleanor; Veloso, Valdilea G.; Parsons, Teresa; Watts, D. Heather; Moye, Jack; Mofenson, Lynne M.; Camarca, Margaret; Bryson, Yvonne; Morgado, Mariza; Yu, Eunice; Bethel, James; Hawkins, Elizabeth; Smith, Elizabeth; Zwerski, Sheryl; McDonough, Marita D.; Lancaster, Charles T.; PharoRuth, Cristina; Dickover, Ruth E.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 47, No. 3, 03.2008, p. 334-337.

Research output: Contribution to journalArticle

Mirochnick, M, Nielsen-Saines, K, Pilotto, JH, Pinto, J, Jiménez, E, Veloso, VG, Parsons, T, Watts, DH, Moye, J, Mofenson, LM, Camarca, M, Bryson, Y, Morgado, M, Yu, E, Bethel, J, Hawkins, E, Smith, E, Zwerski, S, McDonough, MD, Lancaster, CT, PharoRuth, C & Dickover, RE 2008, 'Nevirapine concentrations in newborns receiving an extended prophylactic regimen', Journal of Acquired Immune Deficiency Syndromes, vol. 47, no. 3, pp. 334-337. https://doi.org/10.1097/QAI.0b013e31815f3c23
Mirochnick, Mark ; Nielsen-Saines, Karin ; Pilotto, Jose Henrique ; Pinto, Jorge ; Jiménez, Eleanor ; Veloso, Valdilea G. ; Parsons, Teresa ; Watts, D. Heather ; Moye, Jack ; Mofenson, Lynne M. ; Camarca, Margaret ; Bryson, Yvonne ; Morgado, Mariza ; Yu, Eunice ; Bethel, James ; Hawkins, Elizabeth ; Smith, Elizabeth ; Zwerski, Sheryl ; McDonough, Marita D. ; Lancaster, Charles T. ; PharoRuth, Cristina ; Dickover, Ruth E. / Nevirapine concentrations in newborns receiving an extended prophylactic regimen. In: Journal of Acquired Immune Deficiency Syndromes. 2008 ; Vol. 47, No. 3. pp. 334-337.
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AU - Veloso, Valdilea G.

AU - Parsons, Teresa

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AU - Zwerski, Sheryl

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AU - Dickover, Ruth E.

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N2 - 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

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