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Evaluating Bepirovirsen for HIV and Hepatitis B co-infection

A Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection on Antiretroviral Treatment

PHASE2 · GlaxoSmithKline · NCT06497504

This study is testing if a new medication called bepirovirsen can help people who are co-infected with HIV and hepatitis B feel better compared to a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline (industry)
Drugs / interventionsprednisone
Locations50 sites (Bakersfield, California and 49 other locations)
Trial IDNCT06497504 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of bepirovirsen compared to a placebo in participants who are co-infected with human immunodeficiency virus (HIV) and chronic hepatitis B virus (HBV). Participants must have been on a stable antiretroviral therapy regimen for at least 12 months prior to screening. The study aims to determine if bepirovirsen can improve health outcomes for those living with both infections.

Who should consider this trial

Good fit: Ideal candidates are individuals with documented chronic HBV and HIV-1 infections who have been on stable antiretroviral therapy for over 12 months.

Not a fit: Patients who do not have chronic hepatitis B virus infection or those not on stable antiretroviral therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients co-infected with HIV and HBV.

How similar studies have performed: Other studies have shown promise in treating co-infections with innovative therapies, but the specific approach of using bepirovirsen is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Documented chronic hepatitis B virus (HBV) infection and documented human immunodeficiency virus (HIV)-1 infection greater than equal to (\>=) 12 months prior to Screening.
2. Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovir disoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) or emtricitabine (FTC) for greater than (\>)12 months, with no planned changes to the stable regimen over the duration of the study.

   o Switch in ART is permitted \>=6 months prior to Screening for reasons not related to loss of HIV or HBV control (e.g., change in formulary, tolerability, side effects).
3. Documented evidence of at least 2 plasma HIV-1 ribonucleic acid (RNA) measurements less than (\<) 50 copies per milliliter (copies/mL) are required in the 12 months prior to Screening: 1 within 6 to 12 months prior to Screening and 1 within 6 months prior to Screening.
4. Plasma or serum HBV deoxyribonucleic acid (DNA) concentration must be adequately suppressed, defined as plasma or serum HBV DNA \<90 international units per milliliter (IU/mL).
5. Plasma or serum HBsAg concentration \>100 IU/mL and \<=3000 IU/mL.
6. Plasma HIV-1 RNA concentration must be undetectable, defined as plasma HIV 1 RNA \<50 copies/mL.
7. Cluster of differentiation 4 (CD4) count \>=350 cells per cubic millimeter (cells/mm\^3).
8. Alanine aminotransferase (ALT) \<=2 times upper limit of normal (ULN).

Exclusion Criteria:

1. History of or suspected liver cirrhosis and/or evidence of cirrhosis.
2. Diagnosed or suspected hepatocellular carcinoma (HCC).
3. History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
4. Coinfection with:

   1. Hepatitis C virus (HCV) with positive HCV antibody and detectable HCV RNA at Screening.

      I. HCV treatment should have completed \>12 months prior to Screening.
   2. Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.
5. Clinically significant abnormalities, aside from HIV-1 infection and chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV/HIV, acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings.
6. Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) are excluded unless they complete treatment during the Screening period and 7 days prior to randomization.
7. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
8. History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
9. Participants who in the investigator's judgment, have a significant risk of suicide or self-harm.
10. Alcohol or drug abuse/dependence
11. Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (\<=2 weeks) or topical/inhaled steroid use.
12. Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study.
13. Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
14. Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti platelet agents (including but not limited to clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of study intervention, by the discretion of the investigator. Occasional use is permitted.
15. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
16. Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.
17. Prior treatment with bepirovirsen.

Where this trial is running

Bakersfield, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hepatitis B, Antiretroviral treatment, Bepirovirsen, Human immunodeficiency virus, Hepatitis B virus, Placebo

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.