Tenofovir and Hepatitis B Virus Transmission During Pregnancy: A Randomized Clinical Trial.

ABSTRACT:

Importance

Standard care for preventing mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in highly viremic mothers consists of maternal antiviral prophylaxis beginning at gestational week 28 combined with an HBV vaccine series and HBV immune globulin (HBIG) at birth. However, HBIG is unavailable in some resource-limited areas.

Objective

To determine whether initiating tenofovir disoproxil fumarate (TDF) at gestational week 16 combined with HBV vaccinations for infants is noninferior to the standard care of TDF at gestational week 28 combined with HBV vaccinations and HBIG for infants in preventing MTCT in mothers with HBV and high levels of viremia.

Design, setting, and participants

An unblinded, 2-group, randomized, noninferiority clinical trial was con

SUBMITTER: Pan CQ 

PROVIDER: S-EPMC11565373 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature