# Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)

> **NIH NIH R01** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2022 · $403,480

## Abstract

Project Summary/Abstract
Hepatitis B virus (HBV) infection is endemic among pregnant women in Africa yet most women are asymptomatic
and unaware that their infants are at risk. Ninety percent of infants infected at birth will develop chronic HBV
infection with late manifestations of disease that include cirrhosis and hepatocellular carcinoma. The World
Health Organization set a goal of HBV elimination by 2030 but current perinatal prophylaxis in Africa is
inadequate. This is a key barrier to reducing the population prevalence of disease. HBV vaccination from birth is
75-95% effective but low facility delivery rates and vaccine cold chain requirements hinder the success of this
one-pronged approach. Most HBV-exposed infants in Africa receive their first HBV vaccine at 2-3 months of age
which misses the perinatal prevention window. To address this pressing problem, this R01 application describes
gaps in scientific knowledge needed to advance perinatal HBV prevention considering the potential efficacy of
tenofovir therapy in reducing HBV viral load based on two published randomized trials in Asia and a potential
role for neonatal lamivudine prophylaxis. The central goal of this proposal is to identify a novel intervention that
is effective, safe and pragmatic in preventing perinatal transmission of HBV in Africa. This was developed in
response to NICHD priorities cited in PA-18-031. To meet this goal, an innovative, multicenter clinical trial titled
“REVERT-B: Reducing Vertical Transmission of Hepatitis B in Africa” was designed to be carried out by a
collaborative, productive and experienced research team at the University of Alabama at Birmingham (UAB) and
in Cameroon. It will test the hypothesis that maternal and neonatal antiviral prophylaxis significantly reduces
HBV vertical transmission among high-risk women in Africa compared to optimized standard of care (4-dose
HBV vaccination beginning at birth). The hypothesis will be efficiently tested by pursuing two co-primary aims
with a factorial trial design. In Aim 1, a randomized, placebo-controlled trial will be conducted in four prenatal
clinics in Cameroon to test the efficacy of tenofovir in 480 pregnant women with HBV in reducing perinatal
transmission. Women will be randomized to daily tenofovir or placebo with a background of optimized standard
of care (infant vaccination). In Aim 2, neonates will be randomized to oral lamivudine or placebo for six weeks
to test the efficacy of neonatal prophylaxis. The primary endpoint for both aims is perinatal transmission defined
as the proportion of infants with active HBV infection (HBsAg+) at 6 months of age. Sub-aims will assess the
safety of prophylaxis and medication adherence. Data from this Phase III trial will be used to support follow up
studies to test the effectiveness and feasibility of combination maternal and/or neonatal antiviral prophylaxis in
a multi-country study of pregnant women in resource-limited settings. The expected outcome is...

## Key facts

- **NIH application ID:** 10375537
- **Project number:** 5R01HD101545-03
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Jodie Ann Dionne
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $403,480
- **Award type:** 5
- **Project period:** 2020-05-18 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10375537

## Citation

> US National Institutes of Health, RePORTER application 10375537, Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial) (5R01HD101545-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10375537. Licensed CC0.

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