Project Details

Tenofovir in early pregnancy to prevent mother-to-child transmission of hepatitis B virus

Stephan Ehrhardt, MD, MPH, DTMPH

Summary

BACKGROUND: Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of transmission in most high and intermediate HBV endemic areas, despite existing WHO immunoprophylaxis recommendations. GAP: Because one component of the immunoprophylaxis, hepatitis B immunoglobulin, is often not available in low-income countries, global control of HBV transmission will require improved MTCT prevention. One new strategy is to give an antiviral drug like Tenofovir disoproxil fumarate (TDF) but the exact timing for starting the drug in pregnancy is unknown. HYPOTHESIS: TDF given to women early in pregnancy will be effective in reducing HBV DNA to undetectable at birth, making a transmission to the baby extremely unlikely. METHODS: One arm, open label, interventional study in pregnant Chinese women aged 18 and over who are, due to their high HBV DNA levels, likely to transmit HBV to their children at birth. RESULTS: Pending IMPACT: The novel, drug-augmented prevention strategy has the potential to change and improve the way we prevent MTCT of HBV worldwide. When we know exactly when to give the drug, a randomized clinical trial (RCT) will determine if our approach is better than the old, vaccine-only based approach.