Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus
Status:
Unknown status
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
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. This immunoprophylaxis regimen, if given optimally, can
prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires
administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of
birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states,
"…owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in
most settings." Clearly, global control of HBV transmission will require improved MTCT
prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy
will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without
HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF),
an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency
against hepatitis B and its safety record in pregnant women. A randomized, controlled
clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant
women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg.
However, before embarking on a RCT, several critical knowledge gaps need to be addressed
including the ideal timing for TDF initiation. The purpose of this proposal is to address
these knowledge gaps.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health University of Oxford
Collaborators:
Chiang Mai University Shoklo Malaria Research Unit Thrasher Research Fund University of Oxford