Arresting Vertical Transmission of Hepatitis B Virus

NCT ID: NCT03567382

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2020-08-15

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High-risk HBV dyads

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.

Group Type: EXPERIMENTAL

Tenofovir Disoproxil Fumarate

Intervention Type: DRUG

300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.

Monovalent HBV vaccine

Intervention Type: BIOLOGICAL

Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Low-risk HBV dyads

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.

Group Type: EXPERIMENTAL

Monovalent HBV vaccine

Intervention Type: BIOLOGICAL

Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Interventions

Tenofovir Disoproxil Fumarate

300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.

Intervention Type: DRUG

Monovalent HBV vaccine

Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Intervention Type: BIOLOGICAL

Other Intervention Names

Viread; Engerix-B

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinshasa School of Public Health

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Meshnick, MD

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Peyton Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Kinshasa School of Public Health

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

References

Thompson P, Morgan CE, Ngimbi P, Mwandagalirwa K, Ravelomanana NLR, Tabala M, Fathy M, Kawende B, Muwonga J, Misingi P, Mbendi C, Luhata C, Jhaveri R, Cloherty G, Kaba D, Yotebieng M, Parr JB. Arresting vertical transmission of hepatitis B virus (AVERT-HBV) in pregnant women and their neonates in the Democratic Republic of the Congo: a feasibility study. Lancet Glob Health. 2021 Nov;9(11):e1600-e1609. doi: 10.1016/S2214-109X(21)00304-1. Epub 2021 Aug 17.

Reference Type: DERIVED

PMID: 34416175 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IGHID 11720

Identifier Type: OTHER

Identifier Source: secondary_id

17-2090

Identifier Type: -

Identifier Source: org_study_id