Study Comparing Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate to Prevent Mother-to-Child Hepatitis B Transmission in Pregnant Women with High Viral Loads

What this Trial Is About

This research aims to compare how well two treatments, tenofovir alafenamide TAF and tenofovir disoproxil fumarate TDF, prevent mother-to-infant transmission of hepatitis B in pregnant women with high viral loads. The study will measure the rate of hepatitis B transmission to infants by checking if infants are positive for hepatitis B surface antigen and have significant viral levels at 28 weeks of age. It will also assess the safety of both treatments by comparing the rates of birth defects in babies born to mothers who received either drug during pregnancy. Pregnant women will start either TAF 25 mg daily or TDF 300 mg daily from 28 weeks of pregnancy until delivery. After birth, mothers without further treatment indications will be randomly assigned to either stop treatment or continue the assigned drug for an additional 12 weeks. All infants will receive the hepatitis B vaccine and hepatitis B immunoglobulin HBIG within 12 hours after birth, plus booster vaccine doses at 4 and 24 weeks. The study includes follow-up of mothers and infants until 28 weeks postpartum. Participants will be closely monitored through clinical visits and testing during pregnancy and postpartum. Researchers will measure hepatitis B transmission rates, birth defect incidence, viral load levels, liver enzymes, kidney function, adverse events, and mothers quality of life up to 36 weeks. The study lasts from the start of treatment at 28 weeks gestation through 28 weeks after birth, with detailed assessments during and after treatment to understand treatment effects and safety.

Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads