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Study on Bepirovirsen for Patients with HIV and Chronic Hepatitis B on Antiretroviral Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for people living with both Human Immunodeficiency Virus (HIV) and Chronic Hepatitis B Virus (HBV) infection. The treatment being tested is called Bepirovirsen, which is given as a solution for injection. The study will compare the effects of Bepirovirsen to a placebo, which is a substance with no active medication, to see how well it works and how safe it is for participants.

The purpose of the study is to assess the treatment effect of Bepirovirsen over a period of 24 weeks, with the goal of achieving a response in the Hepatitis B Virus 36 weeks after stopping the study treatment. Participants in the study will continue their regular antiretroviral treatment for HIV while receiving the study medication. The study will involve regular visits to monitor the health and progress of the participants, ensuring that the treatment is working as intended and that there are no significant side effects.

Participants will be randomly assigned to receive either Bepirovirsen or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study aims to determine the percentage of participants who achieve undetectable levels of the Hepatitis B surface antigen (HBsAg) and HBV DNA, which are indicators of the virus's presence in the body, 36 weeks after the end of the study treatment. The study will help to understand if Bepirovirsen can be an effective treatment option for those living with both HIV and chronic HBV infection.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying a documented chronic hepatitis B virus (HBV) infection and human immunodeficiency virus (HIV-1) infection for at least 12 months.

    Participants must be on a stable antiretroviral treatment (ART) regimen containing Tenofovir disoproxil (TDF) or Tenofovir alafenamide (TAF) plus Lamivudine (3TC) or Emtricitabine (FTC) for more than 12 months.

    HIV-1 RNA levels must be undetectable, and HBV DNA levels must be adequately suppressed.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, bepirovirsen sodium, or a placebo.

    The study is double-blind, meaning neither the participants nor the researchers know who receives the active medication or the placebo.

  3. Step 3

    Treatment phase

    Participants receive bepirovirsen sodium or placebo as a solution for injection, administered subcutaneously.

    The treatment lasts for 24 weeks, with loading doses designed to achieve a virologic response.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment phase, regular monitoring of health status and response to the medication is conducted.

    Participants are assessed for any side effects and the effectiveness of the treatment.

  5. Step 5

    Post-treatment evaluation

    After completing the 24-week treatment, participants are monitored for an additional 36 weeks to evaluate the long-term effects of the treatment.

    The primary goal is to determine the percentage of participants achieving undetectable levels of HBV surface antigen (HBsAg) and HBV DNA.

Who can join the trial?

9 criteria

  • You must have a documented long-term infection with both **Hepatitis B (HBV)** and **Human Immunodeficiency Virus (HIV)** for at least 12 months before the study starts.
  • You need to be on a stable **Antiretroviral Treatment (ART)**, which is a combination of medicines used to treat HIV, for more than 12 months. This treatment must include specific medicines like **Tenofovir disoproxil (TDF)** or **Tenofovir alafenamide (TAF)**, along with **Lamivudine (3TC)** or **Emtricitabine (FTC)**. There should be no planned changes to this treatment during the study, unless a change was made at least 6 months before the study for reasons not related to losing control over HIV or HBV.
  • You must have proof of at least two blood tests showing your **HIV-1 Ribonucleic acid (RNA)** levels are very low (less than 50 copies/mL) in the 12 months before the study. One test should be done 6 to 12 months before the study, and another within 6 months before the study.
  • Your **HBV DNA** levels in the blood must be well controlled, meaning they are less than 90 International Units per milliliter (IU/mL).
  • Your **HIV-1 RNA** levels in the blood must be undetectable, meaning they are less than 50 copies/mL.
  • Your **Cluster of differentiation 4 (CD4)** count, which is a type of white blood cell important for your immune system, must be 350 cells per cubic millimeter (mm3) or higher.
  • Your **Alanine aminotransferase (ALT)** levels, which is an enzyme related to liver function, must be no more than twice the upper limit of what is considered normal.
  • Both men and women can participate in the study.
  • The study includes people who might be considered vulnerable.

Who cannot join the trial?

7 criteria

  • Individuals who do not have Hepatitis B cannot participate. Hepatitis B is a liver infection caused by the hepatitis B virus.
  • Participants must not have a coinfection with HIV and Hepatitis B. Coinfection means having two infections at the same time.
  • Participants must be on active Antiretroviral treatment (ART) for both HIV and Hepatitis B. ART is a treatment that helps control the virus in the body.
  • Participants must have a Baseline HBV surface antigen (HBsAg) level of less than or equal to 3000 International units per milliliter (IU/mL). HBsAg is a protein on the surface of the hepatitis B virus; its level indicates the amount of virus in the body.
  • Individuals who are not within the specified age range cannot participate. The age range includes adults and adolescents.
  • Both male and female participants are eligible, but those who do not meet the gender criteria cannot participate.
  • Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.
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Investigated drugs

Bepirovirsen is a medication being studied for its potential to help people who have both HIV and chronic Hepatitis B. The goal of using this medication is to see if it can reduce the amount of Hepatitis B virus in the body after 24 weeks of treatment. This study is looking at how effective and safe this medication is for people who are already receiving treatment for both HIV and Hepatitis B.

What is already known about the treatment

Bepirovirsen – Bepirovirsen is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating chronic Hepatitis B, particularly in individuals who are also living with HIV. The medication is in the investigational stage, meaning it is not yet approved for general medical use but is being evaluated for safety and efficacy. It is primarily indicated for reducing the viral load of Hepatitis B in patients who are already on antiretroviral therapy for HIV. Bepirovirsen works by targeting and inhibiting the replication of the Hepatitis B virus at the molecular level, potentially leading to a decrease in the virus's presence in the body. It is classified as an antiviral agent.

Investigated diseases

Hepatitis B – Hepatitis B is a viral infection that affects the liver, caused by the Hepatitis B virus (HBV). It can lead to both acute and chronic disease, with the virus being transmitted through contact with infectious body fluids. In the acute phase, symptoms may include jaundice, fatigue, and abdominal pain, but some individuals may not show any symptoms. Chronic Hepatitis B can progress over time, potentially leading to liver damage, cirrhosis, or liver cancer. The virus can remain in the body for a long time, and its progression varies among individuals. Regular monitoring is essential to understand the disease's impact on the liver.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509588-25-00Protocol code219231Estimated enrolment150 patientsSponsorGlaxosmithkline Research & Development Limited

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