Active not recruitingPHASE2INTERVENTIONAL

Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)

This research study, called B-Focus, is investigating whether a new drug, Bepirovirsen, can help people living with both HIV and chronic (long-term) Hepatitis B. Participants will either receive Bepirovirsen or a placebo, which is an inactive treatment made to look just like the study drug. The main goal is to carefully check if Bepirovirsen is both effective and safe for this group of people. If successful, it could offer a new way to manage Hepatitis B in those also living with HIV. The study is currently in Phase 2, meaning it's still in the early stages of testing.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

153

Start

17 Sep 2024

Estimated completion

22 Apr 2027

Hepatitis B

What is this study about?

This study is focused on people who have two long-term conditions: HIV and Hepatitis B. Both are viral infections, and managing them together can be complex. Currently, medications help control both viruses, but researchers are always looking for new and better treatments.

This particular study is testing a new medication called Bepirovirsen. The aim is to see if it can specifically help to reduce the amount of Hepatitis B virus in the body and potentially lead to better long-term health for people who have both HIV and Hepatitis B. They want to find out if it's safe to use and if it actually works better than not taking the study drug.

By carefully comparing Bepirovirsen to a placebo (an inactive dummy treatment), the researchers can understand the true effects of the new medication. This kind of research is really important because it helps doctors find new ways to treat serious health conditions and improve the lives of patients.

Key takeaways

This study is testing a new drug for Hepatitis B in people also living with HIV.
It's called Bepirovirsen and is compared against a dummy treatment (placebo).
You must have well-controlled HIV and Hepatitis B to qualify.
The study aims to see if the new drug is safe and effective.
Participation involves regular check-ups and medical tests.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have both long-term HIV and long-term Hepatitis B infections, diagnosed at least a year ago. It's crucial that your HIV is well-controlled; you must have been consistently taking your HIV medication for over a year, and the HIV virus must be undetectable in your blood tests for at least the past year.

Your Hepatitis B must also be well-managed, with a low amount of the virus in your blood. However, you must still have a certain level of a specific Hepatitis B marker (HBsAg) in your blood, which the researchers are looking to reduce. Your liver health, shown by certain blood tests, needs to be generally good, and you shouldn't have any signs of severe liver damage like cirrhosis or liver cancer.

There are also some reasons why you might not be able to join. For example, if you have other serious liver problems or certain conditions linked to Hepatitis B, or if you also have Hepatitis C with an active infection. The study team will review all your medical information carefully to see if you're a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with both HIV and Hepatitis B for at least a year?
Is your HIV well-controlled with medication, and is the virus undetectable?
Are you currently on regular HIV medication that includes tenofovir and lamivudine or emtricitabine?
Do you have some amount of the Hepatitis B virus in your blood, but it's generally well-managed?
Do you have good liver health without signs of severe damage like cirrhosis or liver cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be tested for Bepirovirsen or a placebo. You would have regular appointments for check-ups, blood tests, and possibly other scans or tests. These appointments would be to monitor your health, how well the treatment is working, and to check for any side effects. You would continue to take your regular HIV medication without any changes. The total duration of your participation in the study, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment before it's widely available, which could improve your health. However, there are also potential risks, as Bepirovirsen is still being studied, and its full effects, including side effects, are not yet completely known. You might not receive the active drug, as some participants will be given a placebo. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (51)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
Verified postcode
Bakersfield, United States
GSK Investigational Site
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San Francisco, United States
GSK Investigational Site
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Orlando, United States
GSK Investigational Site
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West Palm Beach, United States
GSK Investigational Site
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Baltimore, United States
GSK Investigational Site
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Minneapolis, United States
GSK Investigational Site
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Hillsborough, United States
GSK Investigational Site
Verified postcode
Almagro, Argentina
GSK Investigational Site
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Buenos Aires, Argentina
GSK Investigational Site
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Buenos Aires, Argentina
GSK Investigational Site
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Buenos Aires, Argentina
GSK Investigational Site
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La Plata, Argentina

Common questions

What is Bepirovirsen?

Bepirovirsen is a new medication being tested to see if it can help people with Hepatitis B, especially those who also have HIV.

What is a placebo?

A placebo is a dummy treatment that looks just like the study drug but contains no active medicine. It helps researchers compare the new drug's effects accurately.

Why are people with HIV being included?

The study aims to find out if Bepirovirsen is safe and effective for people who have both HIV and Hepatitis B, as managing both can be challenging.

Will my regular HIV medication change?

No, you must continue taking your current HIV medication consistently throughout the study, and no changes are planned for your HIV treatment.

How long does the study last?

The exact length of the study for each participant will be explained by the study team, as it can vary depending on the trial's design.