What is the mechanism of action of this treatment?

Common treatments for Chronic Hepatitis B (CHB) include nucleos(t)ide analogues and antisense oligonucleotides (ASOs). Nucleos(t)ide analogues, such as entecavir and tenofovir, inhibit the reverse transcriptase enzyme, essential for HBV DNA replication, thereby reducing viral load and liver damage. ASOs like Bepirovirsen target HBV mRNA, preventing the production of viral proteins necessary for the virus's life cycle, which can reduce viral antigenemia and viremia. These mechanisms are crucial for CHB patients as they help in selecting effective treatments, potentially leading to better long-term outcomes and reduced liver damage.

What side effects are associated with this type of intervention?

Common treatments for Chronic Hepatitis B, such as entecavir, lamivudine, and pegylated interferon, have various side effects. Entecavir and lamivudine can cause headaches, fatigue, dizziness, and gastrointestinal issues like nausea. Pegylated interferon may lead to flu-like symptoms, depression, and hematologic abnormalities such as neutropenia and thrombocytopenia. Antisense oligonucleotides, like bepirovirsen, may cause injection site reactions, flu-like symptoms, and potential liver enzyme elevations. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Hepatitis B, including nucleos(t)ide analogues like entecavir and tenofovir, which are known for their potent antiviral activity and low resistance rates in treatment-naïve patients. Entecavir is particularly effective in reducing HBV DNA levels and normalizing ALT levels but is not recommended for patients with lamivudine-resistant HBV due to higher resistance rates. Tenofovir is preferred in such cases. Pegylated interferon (PegIFN) has also been approved and is used either alone or in combination with nucleos(t)ide analogues for its ability to induce HBeAg seroconversion and HBsAg loss. While Bepirovirsen, an antisense oligonucleotide targeting HBV mRNA, is still under investigation, it represents a novel approach compared to these existing therapies.

What other types of research exist?

Promising novel alternatives to Bepirovirsen for Chronic Hepatitis B patients include: 1) AB-506, a capsid inhibitor that inhibits HBV pregenomic RNA encapsidation, showing potent antiviral activity in Phase 1 studies. 2) Tenofovir alafenamide (TAF), a nucleotide analogue with a better safety profile compared to tenofovir disoproxil fumarate (TDF), effective in both HBeAg-positive and HBeAg-negative patients. 3) Pegylated interferon (PegIFN) combined with nucleos(t)ide analogues, which has shown improved rates of HBeAg and HBsAg loss in various studies. These alternatives offer different mechanisms of action and have demonstrated efficacy in clinical trials.

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Antisense Oligonucleotide

Bepirovirsen for Chronic Hepatitis B (B-Well 2 Trial)

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 weeks

Awards & highlights

Summary

This trial is testing bepirovirsen, a medication that aims to lower a key protein made by the hepatitis B virus. Bepirovirsen has shown reductions in viral components in cell culture and animal models. It targets patients with specific levels of this protein in their blood. The goal is to see if bepirovirsen can better control the infection compared to current treatments.

Who is the study for?

This trial is for adults with chronic Hepatitis B who've been on stable antiviral therapy for at least 6 months, have low viral DNA levels in their blood, and normal to slightly elevated liver enzymes. They must not have other infections like HIV or Hepatitis C/D, no recent cancer except certain skin cancers, and can't be on immune-suppressing drugs or have a history of drug abuse.

What is being tested?

The study tests the effectiveness of Bepirovirsen compared to a placebo in suppressing the hepatitis B virus when taken alongside standard antiviral treatment. It's divided into stages including initial double-blind treatment, continued antiviral therapy, potential cessation of antivirals, and monitoring durability of response over approximately two years.

What are the potential side effects?

While specific side effects are not listed here, similar treatments often cause flu-like symptoms (fever, fatigue), injection site reactions (redness or pain), possible liver enzyme elevations indicating liver irritation/inflammation. Participants will be monitored closely for any adverse effects throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants achieving functional cure (FC) with baseline HBsAg ≤3000 IU/mL

Secondary study objectives

Number of participants achieving FC with baseline HBsAg ≤1000 IU/mL

Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg ≤1000 IU/mL

Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg ≤3000 IU/mL

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BepirovirsenExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bepirovirsen

2023

Completed Phase 1

~160

Do I qualify?Apply below to find out

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

Common treatments for Chronic Hepatitis B (CHB) include nucleos(t)ide analogues and antisense oligonucleotides (ASOs). Nucleos(t)ide analogues, such as entecavir and tenofovir, inhibit the reverse transcriptase enzyme, essential for HBV DNA replication, thereby reducing viral load and liver damage. ASOs like Bepirovirsen target HBV mRNA, preventing the production of viral proteins necessary for the virus's life cycle, which can reduce viral antigenemia and viremia. These mechanisms are crucial for CHB patients as they help in selecting effective treatments, potentially leading to better long-term outcomes and reduced liver damage.

In vivo reduction of hepatitis B virus antigenemia and viremia by antisense oligonucleotides.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,788 Previous Clinical Trials

8,175,936 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,601 Previous Clinical Trials

6,144,143 Total Patients Enrolled

Media Library

Bepirovirsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05630820 — Phase 3

Chronic Hepatitis B Research Study Groups: Bepirovirsen, Placebo

Chronic Hepatitis B Clinical Trial 2023: Bepirovirsen Highlights & Side Effects. Trial Name: NCT05630820 — Phase 3

Bepirovirsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630820 — Phase 3

Chronic Hepatitis B Patient Testimony for trial: Trial Name: NCT05630820 — Phase 3

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