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Clinical Trial
. 2014;19(6):587-95.
doi: 10.3851/IMP2739. Epub 2014 Jan 24.

Antiretroviral pharmacokinetics in mothers and breastfeeding infants from 6 to 24 weeks post-partum: results of the BAN Study

Amanda H Corbett  1 , Dumbani Kayira, Nicole R White, Nicole L Davis, Athena P Kourtis, Charles Chasela, Francis Martinson, Grace Phiri, Bonaface Musisi, Deborah Kamwendo, Michael G Hudgens, Mina C Hosseinipour, Julie Ae Nelson, Sascha R Ellington, Denise J Jamieson, Charles van der Horst, Angela Kashuba; BAN Study Team
Affiliations
Clinical Trial

Antiretroviral pharmacokinetics in mothers and breastfeeding infants from 6 to 24 weeks post-partum: results of the BAN Study

Amanda H Corbett et al. Antivir Ther. 2014.

Abstract

Background: An intensive, prospective, open-label pharmacokinetic (PK) study in a subset of HIV-infected mothers and their uninfected infants enrolled in the Breastfeeding, Antiretroviral and Nutrition (BAN) Study was performed to describe drug exposure and antiviral response.

Methods: Women using Combivir(®) (zidovudine [ZDV] + lamivudine [3TC]) +Aluvia(®) (lopinavir/ritonavir [LPV/RTV]) were enrolled. Breast milk (BM), mother plasma (MP) and infant plasma (IP) samples were obtained over 6 h after observed dosing at 6, 12 or 24 weeks post-partum for drug concentrations and HIV RNA.

Results: A total of 30 mother/infant pairs (10 each at 6, 12 and 24 weeks post-partum) were enrolled. Relative to MP, BM concentrations of ZDV and 3TC were 35% and 21% higher, respectively, whereas LPV and RTV were 80% lower. Only 3TC was detected in IP with concentrations 96% and 98% lower than MP and BM, respectively. Concentrations in all matrices were similar at 6-24 weeks. The majority (98.3%) of BM concentrations were >HIV(wt) IC50, with one having detectable virus. There was no association between PK parameters and MP or BM HIV RNA.

Conclusions: ZDV and 3TC concentrated in BM whereas LPV and RTV did not, possibly due to protein binding and drug transporter affinity. Undetectable to low antiretroviral concentrations in IP suggest prevention of transmission while breastfeeding may be due to antiretroviral effects on systemic or BM HIV RNA in the mother. Low IP 3TC exposure may predispose an infected infant to HIV resistance, necessitating testing and treating infants early.

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Figures

Figure 1a
Figure 1a
Median (IQR) Zidovudine Concentation vs Time Profile
Figure 1b
Figure 1b
Median (IQR) Lamivudine Concentration vs Time Profile
Figure 1c
Figure 1c
Median (IQR) Lopinavir Concentration vs Time Profile
Figure 1d
Figure 1d
Median (IQR) Ritonavir Concentration vs Time Profile
Figure 2
Figure 2
Correlations Between Breast Milk Concentrations and Mothers’ Plasma Concentrations
See this image and copyright information in PMC

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