Antiretroviral Concentrations in Breast-Feeding Infants of Mothers Receiving Highly Active Antiretroviral Therapy
Mark Mirochnick,Timothy K. Thomas,Edmund V. Capparelli,Clement Zeh,Diane T. Holland,Rose Masaba,Prisca Odhiambo,Mary Glenn Fowler,Paul J. Weidle,Michael C. Thigpen +9 more
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TLDR
Lamivudine and nevirapine, but not zidovudine, are transferred to infants via breast milk in biologically significant concentrations, and the extent and effect of infant drug exposure via breasts must be well understood in order to evaluate the benefits and risks of maternal antiretroviral use during lactation.Abstract:
There are limited data describing the concentrations of zidovudine, lamivudine, and nevirapine in nursing infants as a result of transfer via breast milk. The Kisumu Breastfeeding Study is a phase IIb open-label trial of prenatal, intrapartum, and postpartum maternal treatment with zidovudine, lamivudine, and nevirapine from 34 weeks of gestation to 6 months postpartum. In a pharmacokinetic substudy, maternal plasma, breast milk, and infant dried blood spots were collected for drug assay on the day of delivery and at 2, 6, 14, and 24 weeks after delivery. Sixty-seven mother-infant pairs were enrolled. The median concentrations in breast milk of zidovudine, lamivudine, and nevirapine during the study period were 14 ng/ml, 1,214 ng/ml, and 4,546 ng/ml, respectively. Zidovudine was not detectable in any infant plasma samples obtained after the day of delivery, while the median concentrations in infant plasma samples from postpartum weeks 2, 6, and 14 were 67 ng/ml, 32 ng/ml, and 24 ng/ml for lamivudine and 987 ng/ml, 1,032 ng/ml, and 734 ng/ml for nevirapine, respectively. Therefore, lamivudine and nevirapine, but not zidovudine, are transferred to infants via breast milk in biologically significant concentrations. The extent and effect of infant drug exposure via breast milk must be well understood in order to evaluate the benefits and risks of maternal antiretroviral use during lactation.read more
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References
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Laura Guay,Philippa Musoke,Thomas Fleming,Danstan Bagenda,Melissa Allen,Clemensia Nakabiito,Joseph Sherman,Paul M Bakaki,Constance Ducar,Martina Deseyve,Lynda Emel,Mark Mirochnick,Mary Glenn Fowler,Lynne M. Mofenson,Paolo G. Miotti,Kevin Dransfield,Dorothy Bray,Francis Mmiro,J. Brooks Jackson +18 more
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Ruth Nduati,Grace John,Dorothy Mbori-Ngacha,Barbra A. Richardson,Julie Overbaugh,Anthony Mwatha,Jeckoniah O. Ndinya-Achola,Job J. Bwayo,F E Onyango,James P. Hughes,Joan K. Kreiss +10 more
TL;DR: Most breast milk transmission occurred early, with 75% of the risk difference between the 2 arms occurring by 6 months, although transmission continued throughout the duration of exposure, and the use of breast milk substitutes prevented 44% of infant infections and was associated with significantly improved HIV-1-free survival.
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