NCT03567382

Arresting Vertical Transmission of Hepatitis B Virus

Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hepatitis B
• Vertical Transmission of Infectious Disease

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate	300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.
BIOLOGICAL	Monovalent HBV vaccine	Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Timeline

• Start date: 2018-09-24
• Primary completion: 2020-03-06
• Completion: 2020-08-15
• First posted: 2018-06-25
• Last updated: 2021-02-24
• Results posted: 2021-02-05

Locations

1 site across 1 country: Democratic Republic of the Congo

Regulatory

• FDA-regulated drug study