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Breastmilk transfer and infant exposure to atazanavir/ritonavir in breastfeeding women with HIV: results from IMPAACT 2026

Article scientifique 2026 Anglais

Résumé

Background: Breastfeeding offers significant health benefits, and guidance for women with HIV increasingly emphasizes individualized, informed infant-feeding decisions. Breastmilk antiretroviral transfer and safety data are needed to inform shared decision-making discussions across all settings. Methods: Breastmilk transfer of ritonavir (RTV)-boosted atazanavir (ATV) was evaluated in the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2026 study. Fourteen breastfeeding women with HIV receiving RTV boosted ATV 100/300 mg daily, as part of a multi-drug regimen, and their infants were enrolled in Kenya, Uganda, and South Africa between 5 and 9 days postpartum and followed through age 16-24 weeks. Paired maternal plasma, breastmilk, and infant plasma samples were collected at each visit. Concentrations were measured using validated LC-MS/MS methods. Relative infant dose (RID) was estimated assuming an infant milk intake of 150 mL/kg/day. Safety outcomes were prospectively assessed. Results: All 14 women reported exclusive breastfeeding. Median maternal plasma and breastmilk concentrations were 1,410 ng/mL and 432 ng/mL for ATV, and 217 ng/mL and 13.6 ng/mL for RTV, respectively. Median breastmilk-to-plasma ratios were 0.253 (ATV) and 0.081 (RTV). RID values were 1.27% (maximum 6.43%) for ATV and 0.12% (maximum 1.10%) for RTV. Infant plasma concentrations were below the lower limit of quantitation (ATV 23.4 ng/mL; RTV 9.8 ng/mL) in all 42 samples. No maternal adverse events occurred; three infants experienced unrelated grade 2 events. Conclusions: In this cohort, ATV and RTV were detectable in maternal plasma and breastmilk but not in infant plasma, with low RID estimates and a favorable safety profile.

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Barr, E., Pinilla, M., Momper, J., Eke, A., Koech, L., Brooks, K., Ndyanabangi, V., Burchett, S., Valiyaparambil, S., Mirochnick, M., Stek, A., Best, B., Jeffrey, R., Stotz, C., Schalkwyk, M., Browning, R., Shapiro, D., Powis, K. (2026). Breastmilk transfer and infant exposure to atazanavir/ritonavir in breastfeeding women with HIV: results from IMPAACT 2026. https://doi.org/10.3389/frph.2026.1892081

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Auteur(s)

Emily Barr Mauricio Pinilla Jeremiah D. Momper Ahizechukwu C. Eke Lucy Koech Kristina M. Brooks Victoria Ndyanabangi Sandra K. Burchett Sujith Valiyaparambil Mark Mirochnick Alice Marie Stek Brookie M. Best Rachael Jeffrey Chelsea Stotz Marije Van Schalkwyk Renee Browning David E. Shapiro Kathleen M. Powis

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