Hepatitis BPhase 2B-FocusNCT06497504
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
A Phase 2 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 51 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Bepirovirsen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 51 sitesin 10 countries
- Study dates
- 17 Sep 2024to 22 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
- HCV treatment should have completed >12 months prior to Screening.
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- 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.
- Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
- 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.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
- Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.
- Prior treatment with bepirovirsen.
Trial locations and contacts
51 sites in 10 countries.
51 sites in 10 countries
United States7 sites
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Baltimore, Maryland, 21287
GSK Investigational Site
Hillsborough, New Jersey, 08844
GSK Investigational Site
Minneapolis, Minnesota, 55415
GSK Investigational Site
Orlando, Florida, 32803-1851
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
West Palm Beach, Florida, 33409
Argentina6 sites
GSK Investigational Site
Almagro, C1427CEA
GSK Investigational Site
Buenos Aires, 1023
GSK Investigational Site
Buenos Aires, C1181ACI
GSK Investigational Site
Buenos Aires, C1425AGC
GSK Investigational Site
La Plata, B1900AVG
GSK Investigational Site
Rosario, S2002KDR
Brazil6 sites
GSK Investigational Site
Aracaju, 49060-010
GSK Investigational Site
Campinas, 13034-685
GSK Investigational Site
Curitiba, 80810-050
GSK Investigational Site
Manaus, 69040-000
GSK Investigational Site
Salvador, 40110-060
GSK Investigational Site
São Paulo, 04121-000
France6 sites
GSK Investigational Site
Marseille, 13003
GSK Investigational Site
Melun, 77000
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75012
GSK Investigational Site
Paris, 75018
Italy6 sites
GSK Investigational Site
Genova, 16132
GSK Investigational Site
Milan, 20157
GSK Investigational Site
Milan, 20162
GSK Investigational Site
Naples, 80131
GSK Investigational Site
Roma, 00153
GSK Investigational Site
Sassari, 07100
Spain6 sites
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Córdoba, 14004
GSK Investigational Site
Madrid, 28031
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
Canada5 sites
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Montreal, Quebec, H4A 3J1
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Québec, Quebec, G1V 4G2
GSK Investigational Site
Toronto, Ontario, M5G 1K2
United Kingdom4 sites
GSK Investigational Site
Bristol Avon, BS10 5NB
GSK Investigational Site
London, E1 1BB
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, SE5 9RS
South Africa3 sites
GSK Investigational Site
Durban, KwaZulu-Natal, 4052
GSK Investigational Site
Ekurhuleni, 1459
GSK Investigational Site
Johannesburg, 2092
Taiwan2 sites
GSK Investigational Site
Banchiau Taipei, 220
GSK Investigational Site
Kaohsiung City, 813
About this study
Official title: 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
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
- Being tested
- Bepirovirsen, Placebo
- Keywords
- Antiretroviral treatment, Bepirovirsen, Human immunodeficiency virus, Hepatitis B virus, Placebo
- Medical subject headings
- Hepatitis B, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepirovirsenDrug
Bepirovirsen will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Bepirovirsen | Experimental | Participants will receive bepirovirsen. Receives: Drug: Bepirovirsen |
| Participants receiving Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
HBV virologic response defined as HBsAg not detected and HBV DNA <LLOQ.
Measured: At study week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start17 Sep 2024
- Primary completion22 Apr 2027 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497504
- Sponsor's protocol ID
- 219231
- Other IDs
- 2023-509588-25, 2023-509588-25-00, 2023
- Acronym
- B-Focus
- Status last verified
- Nov 2026
- First submitted
- 5 Jul 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06497504
- Acronym / sponsor ID
- B-Focus / 219231
- Conditions
- Hepatitis B
- Keywords
- Antiretroviral treatment, Bepirovirsen, Human immunodeficiency virus, Hepatitis B virus, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Bepirovirsen | Experimental | Drug: BepirovirsenParticipants will receive bepirovirsen. |
| Participants receiving Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (20 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BepirovirsenBepirovirsen will be administered. | Drug | Participants receiving Bepirovirsen |
| PlaceboPlacebo will be administered. | Drug | Participants receiving Placebo |
Primary outcome
Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication
Time frame: At study week 60
HBV virologic response defined as HBV surface antigen (HBsAg) not detected and HBV deoxyribonucleic acid (DNA) less than (<) lower limit of quantification (LLOQ).
1 secondary outcome
Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication
Time frame: At study week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
51 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 51 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Argentina, Brazil, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication (time frame: At study week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.