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Abstract
Infant Nevirapine Dosing for the Prevention of Mother-to-Child Transmission in Association with Timing of Maternal Intrapartum Nevirapine Dose: Initiatives of the United States Pharmacopeia Drug Quality and Information Program (USP DQI)
Seyoum D.1, Primo-Carpenter J.1
Introduction: The two-dose nevirapine regimen for the prevention of mother-to-child transmission (MTCT) of HIV-1 infection was designed to maintain nevirapine concentrations of more than 100 ng/mL, i.e., 10-times the in vitro IC50 of nevirapine against wild-type virus, in the newborn throughout the first week of life. The recommendation that nevirapine may be considered as one of several strategies in the prevention of MTCT of HIV-1 infection in resource-poor settings was based on this two-dose nevirapine regimen, a single 200-mg oral nevirapine dose administered to the mother during labor and a single 2 mg/kg oral nevirapine dose given to the infant at 48 to 72 hours after birth. However, recent studies indicated that infants born less than 2 hours after maternal nevirapine dosing may have cord blood concentrations of nevirapine below the target concentration.
Methods: The United States Pharmacopeia Drug Quality and Information Program (USP DQI) analyzed published articles on nevirapine dosing for the prevention of MTCT. Analysis was focused on published clinical trials on cord blood and predose nevirapine concentrations in infants exposed to the two-dose intrapartum neonatal regimen and were born less than 2 hours after maternal nevirapine dosing. USP DQI presented the analysis in the form of evidence tables to the USP Drug Information Expert Committees for further review.
Results: Lower predose nevirapine concentrations were associated with lower cord blood concentrations and a shorter interval between maternal dosing and delivery.
Conclusions: The USP Drug Information Expert Committees recommended that infants born less than 2 hours after maternal nevirapine dosing during labor should receive a dose of nevirapine immediately after birth in addition to the standard infant dose at 48 to 72 hours.
The 3rd IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
TuPe5.6P01
Suggested Citation
"SeyoumD., et al.
Infant Nevirapine Dosing for the Prevention of Mother-to-Child Transmission in Association with Timing of Maternal Intrapartum Nevirapine Dose: Initiatives of the United States Pharmacopeia Drug Quality and Information Program (USP DQI).
Poster Exhibition:
The 3rd IAS Conference on HIV Pathogenesis and Treatment:
Abstract no.
TuPe5.6P01"
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