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

NCT06497504 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2192312023-509588-25
• Study Type: interventional
• Target: 157
• Locations: 10 countries
• Sites: 51

Brief 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.

Conditions

Hepatitis B

Keywords

Antiretroviral treatment; Bepirovirsen; Human immunodeficiency virus; Hepatitis B virus; Placebo

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication

  HBV virologic response defined as HBV surface antigen (HBsAg) not detected and HBV deoxyribonucleic acid (DNA) less than (\<) lower limit of quantification (LLOQ).

  At study week 60

Secondary Outcomes (1)

• Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication

  At study week 24

Study Arms (2)

Participants receiving Bepirovirsen

EXPERIMENTAL

Participants will receive bepirovirsen.

Drug: Bepirovirsen

Participants receiving Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

Bepirovirsen DRUG

Bepirovirsen will be administered.

Participants receiving Bepirovirsen

Placebo DRUG

Placebo will be administered.

Participants receiving Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented chronic hepatitis B virus (HBV) infection and documented human immunodeficiency virus (HIV)-1 infection greater than equal to (\>=) 12 months prior to Screening.
• 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).
• 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.
• 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).
• Plasma or serum HBsAg concentration \>100 IU/mL and \<=3000 IU/mL.
• Plasma HIV-1 RNA concentration must be undetectable, defined as plasma HIV 1 RNA \<50 copies/mL.
• Cluster of differentiation 4 (CD4) count \>=350 cells per cubic millimeter (cells/mm\^3).
• Alanine aminotransferase (ALT) \<=2 times upper limit of normal (ULN).

You may not qualify if:

• History of or suspected liver cirrhosis and/or evidence of cirrhosis.
• Diagnosed or suspected hepatocellular carcinoma (HCC).
• History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
• Coinfection with:
• 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.
• Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.
• 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.
• 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.
• 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.
• 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).
• Participants who in the investigator's judgment, have a significant risk of suicide or self-harm.
• Alcohol or drug abuse/dependence
• 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.
• Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (51)

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Orlando, Florida, 32803, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21287, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55415, United States

Location

GSK Investigational Site

Hillsborough, New Jersey, 08844, United States

Location

GSK Investigational Site

Almagro, C1427CEA, Argentina

Location

GSK Investigational Site

Buenos Aires, 1023, Argentina

Location

GSK Investigational Site

Buenos Aires, C1181ACI, Argentina

Location

GSK Investigational Site

Buenos Aires, C1425AGC, Argentina

Location

GSK Investigational Site

La Plata, B1900AVG, Argentina

Location

GSK Investigational Site

Rosario, S2002KDR, Argentina

Location

GSK Investigational Site

Aracaju, 49060-010, Brazil

Location

GSK Investigational Site

Campinas, 13034-685, Brazil

Location

GSK Investigational Site

Curitiba, 80810-050, Brazil

Location

GSK Investigational Site

Manaus, 69040-000, Brazil

Location

GSK Investigational Site

Salvador, 40110-060, Brazil

Location

GSK Investigational Site

São Paulo, 04121-000, Brazil

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1K2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Marseille, 13003, France

Location

GSK Investigational Site

Melun, 77000, France

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75012, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Genova, 16132, Italy

Location

GSK Investigational Site

Milan, 20157, Italy

Location

GSK Investigational Site

Milan, 20162, Italy

Location

GSK Investigational Site

Naples, 80131, Italy

Location

GSK Investigational Site

Roma, 00153, Italy

Location

GSK Investigational Site

Sassari, 07100, Italy

Location

GSK Investigational Site

Durban, 4052, South Africa

Location

GSK Investigational Site

Johannesburg, 2092, South Africa

Location

GSK Investigational Site

Reiger Park, 1459, South Africa

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Madrid, 28032, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Banchiau Taipei, 220, Taiwan

Location

GSK Investigational Site

Kaohsiung City, 813, Taiwan

Location

GSK Investigational Site

Bristol Avon, BS10 5NB, United Kingdom

Location

GSK Investigational Site

London, E1 1BB, United Kingdom

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

AR (6); US (7); CA (5); TW (2); FR (6); IT (6); GB (4); BR (6); ES (6); ZA (3)