What side effects are associated with this type of intervention?

Common treatments for Hepatitis B, such as lamivudine, tenofovir, and entecavir, are generally well-tolerated but can have side effects. Lamivudine may cause headaches, nausea, fatigue, and in some cases, resistance mutations leading to treatment failure. Tenofovir is associated with renal toxicity and bone density loss, while entecavir can cause dizziness, fatigue, and in rare cases, lactic acidosis. Monitoring for these side effects is essential during treatment.

What prior FDA approvals exist?

The FDA has approved several antiviral medications for the treatment of Hepatitis B, focusing on inhibiting HBV replication. These include nucleos(t)ide analogs such as entecavir, tenofovir, lamivudine, and adefovir. Entecavir and tenofovir are often recommended as first-line treatments due to their potent antiviral activity and low risk of developing drug resistance. These medications are effective in suppressing HBV replication and preventing disease progression.

What other types of research exist?

Promising novel alternatives to antiviral medication for Hepatitis B patients include combination therapies involving Pegylated Interferon and nucleos(t)ide analogues, as well as strategic discontinuation protocols of long-term nucleos(t)ide analog therapy in select patients.

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Nucleoside Reverse Transcriptase Inhibitor

Antiviral Therapy for Hepatitis B Transmission Prevention (REVERT-B Trial)

Phase 3

Recruiting

Led By Jodie Dionne, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥16 years

Active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA >1000 IU/ML)

Must not have

Clinical illness requiring hospitalization at the time of enrollment

Known liver cirrhosis or end-stage liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-9 months of age

Awards & highlights

Pivotal Trial

Summary

This trial tests antiviral drugs to prevent hepatitis B transmission from mothers to babies. It focuses on high-risk pregnant women and their newborns in Africa. The drugs lower virus levels in mothers and protect babies until they are vaccinated. One of the drugs, Tenofovir disoproxil fumarate (TDF), has been studied for its ability to prevent the spread of hepatitis B from mothers to their babies.

Who is the study for?

This trial is for pregnant women over 16 years old in Africa, between 14-32 weeks of pregnancy, who have active hepatitis B with a high risk of passing it to their baby. They must plan to deliver at the study facility and be able to consent. Women can't join if they are HIV positive, have very high liver enzymes or serum creatinine levels, are already on tenofovir medication, or have known allergies to the study drugs.

What is being tested?

The REVERT-B study is testing whether antiviral medications Tenofovir Disoproxil Fumarate and Lamivudine Oral Solution can prevent mothers from passing hepatitis B to their newborns during delivery. The effectiveness, safety, how well people tolerate the meds, and adherence will be monitored.

What are the potential side effects?

Possible side effects include digestive issues like nausea or vomiting; fatigue; headache; dizziness; skin rash; and rarely kidney problems or bone pain. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or older.

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I have active hepatitis B with a high risk of passing it to others.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently hospitalized due to my illness.

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I have been diagnosed with liver cirrhosis or end-stage liver disease.

Select...

I am currently on tenofovir medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-9 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-9 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-9 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vertical Transmission of hepatitis B Infection

Virologic Suppression

Secondary study objectives

Composite Adverse Birth Outcomes

Hepatitis B Flare

In utero HBV infection

+5 more

Side effects data

From 2019 Phase 4 trial • 75 Patients • NCT03258710

25%

Nasopharyngitis

23%

Beta 2 microglobulin urine increased

Back pain

Headache

Dental caries

Cough

Osteoarthritis

Appendicitis

100%

80%

60%

40%

20%

Study treatment Arm

Tenofovir Disoproxil Fumarate

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pregnant Women - TenofovirExperimental Treatment1 Intervention

Women will be randomized to early initiation (enrollment at 14-28 weeks pregnant) vs standard initiation (at 28 weeks pregnant) of tenofovir disoproxil fumarate (TDF) 300 mg daily oral medication until delivery.

Group II: Newborn Infants - LamivudinePlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenofovir Disoproxil Fumarate

2005

Completed Phase 4

~2140

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hepatitis B, such as entecavir and tenofovir, work by inhibiting the viral polymerase enzyme, which is essential for HBV DNA synthesis. By blocking this enzyme, these antiviral medications prevent the virus from replicating, thereby reducing the viral load in the patient's body. This mechanism is vital for Hepatitis B patients as it helps control the infection, reduce liver inflammation, and lower the risk of severe liver diseases like cirrhosis and hepatocellular carcinoma.

Hepatitis B virus: promising drug targets and therapeutic implications.