B-Focus

15 evidence topics · 3 sources

Objective

Aim stated in the registry record

“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.” (opens the source at this quote in a new tab)

Population excluded from the pivotal trials

“Participants were excluded from the trial if they had a history, suspicion, or evidence of cirrhosis; co-infection with HCV, HIV, or HDV” (opens the prescribing information at this quote)

Location and study date

Study dates and status in the registry record

Field	Registry entry
Recruitment status	“Active, not recruiting”
Study start (actual)	“2024-09-17”
Primary completion (estimated)	“2027-04-22”
Study completion (estimated)	“2027-04-22”
First posted	“2024-07-11”
Last update posted	“2026-07-08”

Number of study locations

“This study has 51 locations” (opens the source at this quote in a new tab)

Study design

Multicenter, randomized, double-blind, placebo-controlled design

“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” (opens the source at this quote in a new tab)

Design details in the registry record

Field	Registry entry
Allocation	“Randomized”
Interventional model	“Parallel Assignment”
Masking description	“This will be a double-blind study.”
Phase	“Phase 2”
Other study identifiers	“219231”
EU trial number	“2023-509588-25”

Eligibility criteria

Key inclusion criteria

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

Key exclusion criteria

“History of or suspected liver cirrhosis and/or evidence of cirrhosis.” (opens the source at this quote in a new tab)
“Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.” (opens the source at this quote in a new tab)
“Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.” (opens the source at this quote in a new tab)
“Prior treatment with bepirovirsen.” (opens the source at this quote in a new tab)

Treatment

Bepirovirsen or placebo arms

“Participants will receive bepirovirsen.” (opens the source at this quote in a new tab)
“Participants will receive placebo.” (opens the source at this quote in a new tab)

Antiretroviral therapy continued in coinfected patients

“Patients who are taking nucleos(t)ide analog reverse transcriptase inhibitors as part of antiretroviral therapy for HIV-1 and HBV coinfection must not stop taking their nucleos(t)ide analog reverse transcriptase inhibitor therapy unless an HIV healthcare provider has directed them to do so.” (opens the prescribing information at this quote)

Study outcomes

Rationale for using HBV virologic response 36 weeks after the end of treatment as the primary endpoint

Registered primary outcome: HBsAg not detected and HBV DNA below the LLOQ at week 60

“Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication” (opens the source at this quote in a new tab)
“HBV virologic response defined as HBV surface antigen (HBsAg) not detected and HBV deoxyribonucleic acid (DNA) less than (<) lower limit of quantification (LLOQ).” (opens the source at this quote in a new tab)

Registered secondary outcome: response at the end of treatment

“Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication” (opens the source at this quote in a new tab)

Functional cure as the recommended endpoint for finite therapies

“The recommended endpoint of novel therapy is functional cure defined as HBsAg loss using a conventional assay for detection of HBsAg (limit of detection 0.05 IU/mL) and HBV DNA below the lower limit of quantification (i.e. < 10 IU/ml) at 24 weeks off-therapy.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

Statistical analysis description

Number of participants (Planned and analyzed)

Enrollment in the registry record

Field	Registry entry
Enrollment (actual)	“153”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary: study limitations

B-Focus is ongoing, with 153 participants enrolled, primary completion estimated for April 2027, and no results posted on ClinicalTrials.gov, so no efficacy or safety data are available in HIV-1 and HBV coinfection, a population excluded from B-Well 1 and B-Well 2. Participants remain on tenofovir-containing antiretroviral therapy throughout, so the primary outcome measures HBsAg not detected and HBV DNA below the LLOQ 36 weeks after the end of study treatment without discontinuation of nucleos(t)ide analogue therapy, which differs from the off-all-treatment endpoint of the pivotal trials. The registry does not state the bepirovirsen dose or treatment duration.