Evaluating Universal Versus Point-of-Care Antiviral Treatment to Prevent Mother-to-Child Transmission of Hepatitis B in Pregnant Women

What This Trial Is About

Researchers are evaluating two strategies to prevent mother-to-child transmission of hepatitis B virus HBV by comparing a universal antiviral treatment approach with a selective strategy guided by a rapid point-of-care test for hepatitis B core-related antigen HBcrAg-RDT. This study focuses on pregnant women who are hepatitis B surface antigen HBsAg positive, particularly in low- and middle-income countries where viral load testing is often unavailable. The goal is to determine if the selective HBcrAg-RDT strategy is not less effective than the universal treatment strategy in reducing maternal viral load at childbirth, which is a key factor in transmission risk. Participants are divided into two groups one group receives immediate tenofovir disoproxil fumarate TDF antiviral treatment regardless of viral load universal strategy, while the other group undergoes HBcrAg-RDT testing and only those testing positive receive TDF selective strategy. TDF is administered orally at 300 mg daily or every two days if kidney function is reduced. Treatment starts during the inclusion visit and continues until 6 to 8 weeks after delivery. After three months postpartum, women undergo liver disease assessments including various blood tests, ultrasound, and further viral testing, with treatment resumption if needed according to updated guidelines. During the study, participants will attend antenatal care visits at rural or semi-rural primary health centers or hospitals. Their infants will be followed until 9 months old, including testing for HBV infection. The study also includes social science components in selected countries to assess acceptability, knowledge, treatment adherence, and policy factors. Researchers will measure the percentage of mothers with reduced viral load at delivery and the rate of infants positive for HBsAg at 9 months. The trial spans from 2026 to 2029, with detailed monitoring and evaluation of clinical, economic, and behavioral outcomes.

"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"