Mothers with high HBV DNA levels who received tenofovir disoproxil fumarate therapy late in pregnancy had reduced risk for perinatal mother-to-child transmission of hepatitis B virus infection vs. mothers who did not receive treatment, according to published findings in The New England Journal of Medicine.
Researchers also presented the study at The Liver Meeting 2015.
“We designed the current randomized, controlled trial to determine the efficacy and safety of [tenofovir disoproxil fumarate] therapy in mothers who have an HBV DNA level of more than 200,000 IU per milliliter. …[It] showed that 68% of the [tenofovir disoproxil fumarate]-treated mothers had the target HBV DNA level at delivery, which indicates that [tenofovir disoproxil fumarate] reduced maternal viremia,” Calvin Q. Pan, MD, FACP, FACG, of the division of gastroenterology and hepatology, New York University Langone Medical Center, New York University School of Medicine, and colleagues wrote.
In the study, Pan and colleagues randomly assigned 200 pregnant women positive for hepatitis B e antigen (HBeAg) to a dosage of tenofovir disoproxil fumarate (TDF, Gilead Sciences) from 30 to 32 weeks gestation until 4 weeks postpartum, or no treatment. The mothers were followed until 28 weeks postpartum and all infants received immunoprophylaxis after birth. Eighty-eight mothers and infants in the non-treated group and 92 mothers and infants in the TDF-treated group completed the study.