Hepatitis B InfectionPhase 3REVERT-BNCT04704024
Reducing Vertical Transmission of Hepatitis B in Africa
A Phase 3 study testing Tenofovir Disoproxil Fumarate and Lamivudine Oral Solution in people with Hepatitis B Infection, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Hepatitis B Infection
- What is being tested?
- Tenofovir Disoproxil Fumarate and Lamivudine Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2021to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- prenatal clinic patient,
- age ≥16 years,
- 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
- active hepatitis B with risk of vertical transmission (HBsAg+ AND HBV DNA >1000 IU/ML or HbEAg+),
- plan to receive follow up care and deliver at study facility,
- capable of providing informed consent.
Who cannot join
- HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
- known liver cirrhosis or end-stage liver disease,
- elevated liver enzymes (ALT >150 [5x upper limit of normal]),
- elevated serum creatinine (>1.4 mg/dl)
- currently taking tenofovir medication
- allergy or intolerance to tenofovir study medication,
Show all 9Show fewer
- known fetal anomaly in the current pregnancy,
- clinical illness requiring hospitalization at the time of enrollment
- evidence of early labor at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.
Read the detailed description
The REVERT-B trial is a multi-center, phase III, randomized 2x2 factorial study designed to test the efficacy of early maternal TDF vs standard duration and neonatal 3TC prophylaxis compared to matching placebo in preventing HBV MTCT. Eligible pregnant women with HBV in prenatal care (n=450) will be randomized 1:1:1:1 to one of four maternal and neonatal prophylaxis combinations (shown as A-D in the figure below). Women will initiate daily oral TDF early (2nd trimester) or at the standard time per WHO guidelines (3rd trimester) and will continue TDF until delivery. The current WHO standard of care in pregnant women with HBV (EAg+) in Cameroon is TDF prophylaxis from 28 weeks until delivery. Newborns will receive liquid 3TC or matching placebo for the first six months of life to provide coverage until the vaccine series is complete. All infants in the study will be offered the 4-dose HBV vaccine series starting at birth.
The 2x2 factorial design allows for two simultaneous studies where we first assess efficacy of early maternal prophylaxis (Aim 1) and secondarily assess efficacy of neonatal prophylaxis (Aim 2). The study endpoint for both aims is the MTCT rate (proportion of infants HBsAg+) at 6-9 months of age. Women and infants will be followed until 6-9 months after delivery and subaims will assess safety and adherence to maternal TDF and neonatal 3TC. Plasma testing will be used to measure medication adherence.
- Conditions
- Hepatitis B Infection
- Being tested
- Tenofovir Disoproxil Fumarate, Lamivudine Oral Solution
- Keywords
- perinatal infection, hepatitis B in pregnancy
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Also called TDF
oral TDF medication 300 mg daily
Lamivudine Oral SolutionDrug
Also called 3TC
Oral lamivudine with weight-based dosing BID from birth until 6 months of age
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women - Tenofovir | Experimental | Women will be randomized to early initiation (enrollment at 14-28 weeks pregnant) vs standard initiation (28-32 weeks pregnant if high viral load >200,000 IU/mL) of tenofovir disoproxil fumarate (TDF) 300 mg daily oral medication until delivery. Receives: Drug: Tenofovir Disoproxil Fumarate |
| Newborn Infants - Lamivudine | Placebo comparator | Infants exposed to HBV at birth will be randomized to receive oral lamivudine post-exposure prophylaxis or matching placebo. Medication will be administered twice daily for 6 months. Receives: Drug: Lamivudine Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Transmission of hepatitis B Infection
The proportion of infants with Hepatitis B surface antigen positivity (SAg+)
Measured: 6-9 months of age
Virologic Suppression
The proportion of women with a suppressed HBV DNA viral load (<10 IU/mL).
Measured: at/near delivery
Secondary outcomes (15)
Preterm delivery
Delivery <37 weeks gestational age
Measured: assessed at delivery
Low Birth Weight
Infant birth weight <2500 grams
Measured: at birth
spontaneous abortion
unanticipated loss of pregnancy
Measured: between enrollment and 28 weeks gestational age
intrauterine fetal demise
unanticipated loss of pregnancy
Measured: at/after 28 weeks gestational age
Neonatal Death
Mortality after Live Birth
Measured: within 28 days of birth
Composite Adverse Birth Outcomes
PTD, SAB, IUFD, neonatal death
Measured: during pregnancy or up to 28 days after delivery
Maternal Adherence to TDF
HPLC measurement of serum and/or self-report
Measured: within one month of initiation of therapy through time of delivery
Infant Adherence to Lamivudine
HPLC measurement of serum and/or maternal report
Measured: 12-24 weeks after starting Lamivudine
TDF Tolerability
Self-reported TDF tolerability and observed first dose during pregnancy
Measured: from enrollment through delivery
Lamivudine Tolerability
Maternal reported infant lamivudine tolerability
Measured: birth through 24 weeks of age
Hepatitis B Flare
Increase in ALT (>2x ULN) after stopping TDF at delivery
Measured: Within 12-24 weeks after delivery
Incident HIV infection during pregnancy
Maternal HIV infection with seroconversion to positive test
Measured: at delivery
Vertical Transmission and Mode of Delivery
compare rate of HBV vertical transmission between cesarean and vaginal delivery
Measured: infant testing at 6-9 months of age
Time to Virologic Suppression on TDF
Assess number of weeks to HBV DNA < 10 IU/ML
Measured: at/near delivery
Neonatal HBV Viremia
Detection of HBV DNA in plasma
Measured: within 30 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start3 Sep 2021
- Primary completion1 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B InfectionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jodie A. Dionne, MD, University of Alabama at Birmingham
- Investigators
- Jodie Dionne, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704024
- Sponsor's protocol ID
- IRB-300006586
- Other IDs
- 5R01HD101545
- Acronym
- REVERT-B
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2021
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa
- ClinicalTrials.gov ID
- NCT04704024
- Acronym / sponsor ID
- REVERT-B / IRB-300006586
- Conditions
- Hepatitis B Infection
- Keywords
- perinatal infection, hepatitis B in pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.
Detailed description
The REVERT-B trial is a multi-center, phase III, randomized 2x2 factorial study designed to test the efficacy of early maternal TDF vs standard duration and neonatal 3TC prophylaxis compared to matching placebo in preventing HBV MTCT. Eligible pregnant women with HBV in prenatal care (n=450) will be randomized 1:1:1:1 to one of four maternal and neonatal prophylaxis combinations (shown as A-D in the figure below). Women will initiate daily oral TDF early (2nd trimester) or at the standard time per WHO guidelines (3rd trimester) and will continue TDF until delivery. The current WHO standard of care in pregnant women with HBV (EAg+) in Cameroon is TDF prophylaxis from 28 weeks until delivery. Newborns will receive liquid 3TC or matching placebo for the first six months of life to provide coverage until the vaccine series is complete. All infants in the study will be offered the 4-dose HBV vaccine series starting at birth.
The 2x2 factorial design allows for two simultaneous studies where we first assess efficacy of early maternal prophylaxis (Aim 1) and secondarily assess efficacy of neonatal prophylaxis (Aim 2). The study endpoint for both aims is the MTCT rate (proportion of infants HBsAg+) at 6-9 months of age. Women and infants will be followed until 6-9 months after delivery and subaims will assess safety and adherence to maternal TDF and neonatal 3TC. Plasma testing will be used to measure medication adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2x2 factorial
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women - Tenofovir | Experimental | Drug: Tenofovir Disoproxil FumarateWomen will be randomized to early initiation (enrollment at 14-28 weeks pregnant) vs standard initiation (28-32 weeks pregnant if high viral load >200,000 IU/mL) of tenofovir disoproxil fumarate (TDF) 300 mg daily oral medication until delivery. |
| Newborn Infants - Lamivudine | Placebo comparator | Drug: Lamivudine Oral SolutionInfants exposed to HBV at birth will be randomized to receive oral lamivudine post-exposure prophylaxis or matching placebo. Medication will be administered twice daily for 6 months. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- prenatal clinic patient,
- age ≥16 years,
- 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
- active hepatitis B with risk of vertical transmission (HBsAg+ AND HBV DNA >1000 IU/ML or HbEAg+),
- plan to receive follow up care and deliver at study facility,
Key exclusion criteria (9 listed)
- HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
- known liver cirrhosis or end-stage liver disease,
- elevated liver enzymes (ALT >150 [5x upper limit of normal]),
- elevated serum creatinine (>1.4 mg/dl)
- currently taking tenofovir medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil FumarateAlso: TDForal TDF medication 300 mg daily | Drug | Pregnant Women - Tenofovir |
| Lamivudine Oral SolutionAlso: 3TCOral lamivudine with weight-based dosing BID from birth until 6 months of age | Drug | Newborn Infants - Lamivudine |
Primary outcome
Vertical Transmission of hepatitis B Infection
Time frame: 6-9 months of age
The proportion of infants with Hepatitis B surface antigen positivity (SAg+)
Virologic Suppression
Time frame: at/near delivery
The proportion of women with a suppressed HBV DNA viral load (<10 IU/mL).
15 secondary outcomes
Preterm delivery
Time frame: assessed at delivery
Low Birth Weight
Time frame: at birth
spontaneous abortion
Time frame: between enrollment and 28 weeks gestational age
intrauterine fetal demise
Time frame: at/after 28 weeks gestational age
Neonatal Death
Time frame: within 28 days of birth
Composite Adverse Birth Outcomes
Time frame: during pregnancy or up to 28 days after delivery
Maternal Adherence to TDF
Time frame: within one month of initiation of therapy through time of delivery
Infant Adherence to Lamivudine
Time frame: 12-24 weeks after starting Lamivudine
TDF Tolerability
Time frame: from enrollment through delivery
Lamivudine Tolerability
Time frame: birth through 24 weeks of age
Hepatitis B Flare
Time frame: Within 12-24 weeks after delivery
Incident HIV infection during pregnancy
Time frame: at delivery
Vertical Transmission and Mode of Delivery
Time frame: infant testing at 6-9 months of age
Time to Virologic Suppression on TDF
Time frame: at/near delivery
Neonatal HBV Viremia
Time frame: within 30 days of birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodie Dionne, MD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir Disoproxil Fumarate and Lamivudine Oral Solution in people with Hepatitis B Infection, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical Transmission of hepatitis B Infection (time frame: 6-9 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.