What side effects are associated with this type of intervention?

Common treatments for Hepatitis B, such as nucleoside analogues (e.g., entecavir, lamivudine) and pegylated interferon, have various side effects. Entecavir and lamivudine can cause headaches, fatigue, dizziness, and in some cases, resistance mutations. Pegylated interferon may lead to flu-like symptoms, fatigue, depression, and hematologic abnormalities. Antisense oligonucleotides like Bepirovirsen, which target viral RNA, are still under study, but potential side effects could include injection site reactions, flu-like symptoms, and 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 Hepatitis B, primarily focusing on nucleos(t)ide analogs and interferons. Entecavir and tenofovir are prominent nucleos(t)ide analogs known for their potent antiviral activity and low resistance rates in nucleos(t)ide-naïve patients. Pegylated interferon (PegIFN) is another approved treatment, often used for its ability to induce sustained virologic response. While Bepirovirsen, an antisense oligonucleotide targeting viral RNA, is currently under study, it represents a novel approach compared to these traditional therapies.

What other types of research exist?

Promising alternatives to Bepirovirsen for Hepatitis B treatment include RO7062931, a GalNAc-conjugated single-stranded oligonucleotide targeting HBV RNA, and Pegylated Interferon (PegIFN) combined with nucleos(t)ide analogues like entecavir. These treatments have shown efficacy in clinical trials and offer different mechanisms of action that may benefit patients.

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Subcutaneous Bepirovirsen for Hepatitis B

Phase 1

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 between 18 and 65 years old

Must not have

Prior treatment with any oligonucleotide or small interfering ribonucleoside (RNA) siRNA within 12 months before dosing.

Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 64

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well a medication called bepirovirsen is absorbed when injected under the skin using either a traditional vial or a prefilled syringe with a safety feature. Healthy adults are participating to see if both methods are equally effective and safe, and to check if people can safely inject themselves using the prefilled syringe.

Who is the study for?

Healthy adults who can consent to study requirements are eligible for this trial. They must have normal medical evaluations, including lab tests and vital signs, and not be enrolled in other studies. Exclusions include abnormal blood pressure, positive tests for HBV, HCV or HIV, recent COVID-19 symptoms or infection, use of certain medications including immunosuppressives and oligonucleotides, significant blood loss recently, drug abuse history or regular alcohol consumption.

What is being tested?

The study is testing the bioavailability (how well the body absorbs) of Bepirovirsen when delivered from a vial versus a prefilled syringe with safety device in healthy participants. It will also evaluate self-administration using the prefilled syringe and monitor the safety and tolerability of Bepirovirsen.

What are the potential side effects?

While specific side effects are not listed here for Bepirovirsen as it's being tested on healthy individuals primarily for absorption rates rather than treatment efficacy at this stage; generally such trials look out for any adverse reactions ranging from local site reactions to systemic effects.

Eligibility Criteria

Exclusion Criteria

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

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I haven't had treatments with oligonucleotide or siRNA in the last year.

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I have not lost more than 500 mL of blood in the last 3 months.

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I have not been exposed to more than 4 new drugs in the last year.

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I have not shown COVID-19 symptoms or tested positive for it in the last 14 days.

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I do not regularly use drugs, including THC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 64 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants

Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants

Secondary study objectives

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 3 Participants

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 4 Participants

Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4Experimental Treatment1 Intervention

Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.

Group II: Group 3Experimental Treatment1 Intervention

Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.

Group III: Group 2Experimental Treatment1 Intervention

Participants will receive Bepirovirsen PFS SSD administered by HCP.

Group IV: Group 1Experimental Treatment1 Intervention

Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bepirovirsen

2023

Completed Phase 1

~160

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

Common treatments for Hepatitis B include nucleos(t)ide analogs, pegylated interferons, and antisense oligonucleotides. Nucleos(t)ide analogs, such as entecavir and tenofovir, inhibit the viral polymerase enzyme, preventing the virus from replicating its DNA. Pegylated interferons boost the immune system's response to the virus, helping to clear infected cells. Antisense oligonucleotides, like bepirovirsen, bind to viral RNA, blocking its translation and leading to the degradation of viral RNA. These treatments are crucial for Hepatitis B patients as they reduce viral load, decrease liver inflammation, and lower the risk of liver damage and hepatocellular carcinoma.

In vivo reduction of hepatitis B virus antigenemia and viremia by antisense oligonucleotides.[Inhibition of hepatitis B virus by combined siRNAs in vitro].