Arresting Vertical Transmission of Hepatitis B Virus (AVERT-HBV)

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Hepatitis B; Vertical Transmission of Infectious Disease

Treatments: Drug: Tenofovir Disoproxil Fumarate; Biological: Monovalent HBV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03567382

17-2090

IGHID 11720 (Other Identifier)

Details and patient eligibility

About

The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.

Full description

Hepatitis B virus (HBV) is a leading cause of chronic liver disease globally, with devastating complications such as cirrhosis, hepatocellular carcinoma and death. Vertical transmission (VT) of HBV is a worldwide public health concern because infected children are at high risk of developing chronic liver disease. It is a particular problem in the Democratic Republic of the Congo (DRC); preliminary data suggest that approximately 3% of children have HBV infection due to VT. However, VT is preventable. Pregnant women with risk factors can be identified and treatments given which can virtually eliminate transmission. Unfortunately, despite the high burden of HBV, neither HBV testing of pregnant women nor interventions to prevent HBV VT are routinely performed in the DRC and elsewhere in sub-Saharan Africa. This pilot feasibility study will address this healthcare gap by identifying women with HBV early in their pregnancies and intervening to prevent VT by (1) treating mothers with high-risk HBV (defined as HBeAg positivity and/or HBV viremia >10^6) with tenofovir and (2) providing HBV vaccine to HBV-exposed infants within 24 hours of birth. This pilot study will piggyback onto an existing study that is evaluating the DRC's HIV Prevention of Maternal-to-Child Transmission Option B+ (PMTCT+) strategy. Combining programs to prevent VT of HBV and HIV enables using the same personnel and infrastructure to implement both interventions. Furthermore, tenofovir, used to treat HBV infections, is already used in the DRC to treat HIV. Researchers hypothesize that utilizing the existing PMTCT+ infrastructure in the DRC will provide a cost-effective platform to prevent HBV VT. If effective, this model of treatment will inform future public health efforts and wider policy recommendations that can be applied in the DRC and throughout the Sub-Saharan African region to reduce the burden of HBV.

Enrollment: 179 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women receiving care at Binza and Kingasani maternity centers presenting prior to 24 weeks gestation
• Infants born to HBV-positive women

Exclusion criteria

• Participants who are severely sick and who require prolonged hospitalization.
• Any women who do not intend to stay in Kinshasa for prenatal care through delivery

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

179 participants in 2 patient groups

High-risk HBV dyads

Experimental group

Description:

Mothers with high-risk HBV (defined as viral load \>10\^6 and/or HBeAg positivity) will be treated with tenofovir disoproxil fumarate (TDF) to further reduce the risk of vertical transmission of HBV. All HBV-exposed infants (regardless of mother's status of high- or low-risk HBV) will receive monovalent HBV vaccine within 24 hours of life.

Treatment:

Biological: Monovalent HBV vaccine

Drug: Tenofovir Disoproxil Fumarate

Low-risk HBV dyads

Experimental group

Description:

Mothers with low risk HBV (defined as a viral load \<10\^6 and negative HBeAg) will not receive tenofovir disoproxil fumarate therapy during or after pregnancy. Their infants will still receive monovalent HBV vaccine within 24 hours of life.

Treatment:

Biological: Monovalent HBV vaccine