Low levels of tenofovir in breast milk support breastfeeding in HBV-infected mothers treated with tenofovir disoproxil fumarate

Abstract

Objective: Tenofovir disoproxil fumarate (TDF) is recommended for the prevention of mother-to-infant transmission of the hepatitis B virus (HBV). This study investigated the safety of infants whose mothers continued to receive TDF while breastfeeding.

Patients and method: Thirty women taking TDF daily from the second or third trimester of pregnancy to three months postpartum were enrolled. Tenofovir (TFV) concentrations in breast milk were determined and compared with those in umbilical cord (UC) blood and amniotic fluid. Infant growth parameters were assessed at birth, and at 3, 6, and 12 months. TFV uptake experiments were conducted in vitro to elucidate the mechanisms of TFV exposure via breast milk.

Results: TFV concentrations in breast milk ranged from 1.4 to 11.7 ng/mL within 24 h after dosing in the third month postpartum. The median trough concentration of TFV in breast milk was 3.7 (interquartile range, 2.6-6.2) ng/mL, which is lower than that in UC blood (median = 53.5 ng/mL) and amniotic fluid (median = 531.0 ng/mL). The low permeability of TFV in MCF-10A cells may explain the minimal exposure to TFV in breast milk. Body weights, body lengths, and head circumferences of the breastfed infants were comparable to the national standards for physical development.

Conclusion: Infant exposure to TFV from breast milk is much lower than the exposure from placental transfer and swallowing from amniotic fluid. The physical growth parameters of all infants in this study were normal. The findings indicate that breastfeeding is safe for infants of HBV-infected mothers who continue to receive TDF through three months postpartum.

Keywords: Chronic hepatitis B; amniotic fluid; breastfeeding; cord plasma; tenofovir disoproxil fumarate.