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

Last updated: April 24, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatitis

Hiv Infections

Hepatitis B

Treatment

Placebo

Bepirovirsen

Clinical Study ID

NCT06497504
219231
2023-509588-25
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Documented chronic hepatitis B virus (HBV) infection and documented humanimmunodeficiency virus (HIV)-1 infection greater than equal to (>=) 12 months priorto Screening.

  2. Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovirdisoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) oremtricitabine (FTC) for greater than (>)12 months, with no planned changes to thestable regimen over the duration of the study. o Switch in ART is permitted >=6 months prior to Screening for reasons not relatedto loss of HIV or HBV control (e.g., change in formulary, tolerability, sideeffects).

  3. Documented evidence of at least 2 plasma HIV-1 ribonucleic acid (RNA) measurementsless than (<) 50 copies per milliliter (copies/mL) are required in the 12 monthsprior to Screening: 1 within 6 to 12 months prior to Screening and 1 within 6 monthsprior to Screening.

  4. Plasma or serum HBV deoxyribonucleic acid (DNA) concentration must be adequatelysuppressed, defined as plasma or serum HBV DNA <90 international units permilliliter (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 <50copies/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

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:

  5. Hepatitis C virus (HCV) with positive HCV antibody and detectable HCV RNA atScreening. I. HCV treatment should have completed >12 months prior to Screening.

  6. Hepatitis D virus (HDV) defined as positive or equivocal HDV antibodyregardless of HDV RNA level.

  7. Clinically significant abnormalities, aside from HIV-1 infection and chronic HBVinfection in medical history (e.g., moderate severe liver disease other than chronicHBV/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 examinationfindings.

  8. Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screeningwithout clear documentation of treatment) are excluded unless they completetreatment during the Screening period and 7 days prior to randomization.

  9. History of malignancy within the past 5 years with the exception of specific cancersthat are cured by surgical resection (e.g., skin cancer). Participants underevaluation for possible malignancy are not eligible.

  10. History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine withoutidentified cause), current or history of an autoimmune condition or history/presenceof other diseases that may be associated with vasculitis condition (e.g., systemiclupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritismultiplex).

  11. Participants who in the investigator's judgment, have a significant risk of suicideor self-harm.

  12. Alcohol or drug abuse/dependence

  13. Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) ortopical/inhaled steroid use.

  14. Participants to whom immunosuppressive treatment, including therapeutic doses ofsteroids, is contraindicated should not be considered for enrolment in the study.

  15. Currently taking, or has taken within 12 months of Screening, any interferoncontaining therapy.

  16. Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xainhibitors) or anti platelet agents (including but not limited to clopidogrel oraspirin) unless treatment can safely be discontinued throughout duration of studyintervention, by the discretion of the investigator. Occasional use is permitted.

  17. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.

  18. Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.

  19. Prior treatment with bepirovirsen.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 17, 2024
Estimated Completion Date:
April 27, 2027

Connect with a study center

  • GSK Investigational Site

    Almagro, C1427CEA
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires, C1181ACI
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    La Plata, B1900AVG
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, S2002KDR
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Aracaju, 49060-010
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Campinas, 13034-685
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Curitiba, 80810-050
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Manaus, 69040-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    SAo Paulo, 04121-000
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Salvador, 40110-060
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M5G 1K2
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Quebec City, Quebec G1V 4G2
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Québec, G1V 4G2
    Canada

    Site Not Available

  • GSK Investigational Site

    Marseille, 13003
    France

    Active - Recruiting

  • GSK Investigational Site

    Melun, 77000
    France

    Active - Recruiting

  • GSK Investigational Site

    Montpellier Cedex 5, 34295
    France

    Active - Recruiting

  • GSK Investigational Site

    Nantes cedex 1, 44093
    France

    Active - Recruiting

  • GSK Investigational Site

    Paris, 75018
    France

    Active - Recruiting

  • GSK Investigational Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Genova, 16132
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milano, 20157
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Roma, 00153
    Italy

    Site Not Available

  • GSK Investigational Site

    Sassari, 07100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Boksburg, Gauteng 1459
    South Africa

    Site Not Available

  • GSK Investigational Site

    Cape Town, 7925
    South Africa

    Site Not Available

  • GSK Investigational Site

    Durban, 4052
    South Africa

    Active - Recruiting

  • GSK Investigational Site

    Johannesburg, 2092
    South Africa

    Active - Recruiting

  • GSK Investigational Site

    Observatory, Cape Town, 7925
    South Africa

    Site Not Available

  • GSK Investigational Site

    Reiger Park, 1459
    South Africa

    Active - Recruiting

  • GSK Investigational Site

    Westdene, 2092
    South Africa

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Cordoba, 14004
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28032
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Banchiau Taipei, 220
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Kaohsiung, 813
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Bristol Avon, BS10 5NB
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Bakersfield, California 93301
    United States

    Completed

  • GSK Investigational Site

    San Francisco, California 94115
    United States

    Active - Recruiting

  • GSK Investigational Site

    Fort Pierce, Florida 33401
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • GSK Investigational Site

    West Palm Beach, Florida 33409
    United States

    Active - Recruiting

  • GSK Investigational Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • GSK Investigational Site

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

  • GSK Investigational Site

    Hillsborough, New Jersey 08844
    United States

    Active - Recruiting

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