---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Focus"
description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Focus. Covers Objective, Location and study date, Study design, Eligibility criteria, Treatment, Study outcomes, and 2 further headings. 15 evidence topics quoted from 3 sources."
canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence/b-focus"
published: "2026-10-21T22:39:04-04:00"
modified: "2026-10-22T19:07:03-04:00"
---

# Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Focus

<a id="heading-3.1.9"></a>

## 3.1.9 B-Focus

<a id="heading-3.1.9.1"></a>

### 3.1.9.1 Objective

<a id="topic-3.1.9.1-1"></a>

#### 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.”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.1-2"></a>

#### 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”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="heading-3.1.9.2"></a>

### 3.1.9.2 Location and Study Date

<a id="topic-3.1.9.2-1"></a>

#### 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” |

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.2-2"></a>

#### Number of study locations

> “This study has 51 locations”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="heading-3.1.9.3"></a>

### 3.1.9.3 Study Design

<a id="topic-3.1.9.3-1"></a>

#### 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”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.3-2"></a>

#### 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” |

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="heading-3.1.9.4"></a>

### 3.1.9.4 Eligibility Criteria

<a id="topic-3.1.9.4-1"></a>

#### 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.”
> “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.”
> “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).”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.4-2"></a>

#### Key exclusion criteria

> “History of or suspected liver cirrhosis and/or evidence of cirrhosis.”
> “Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.”
> “Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.”
> “Prior treatment with bepirovirsen.”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="heading-3.1.9.5"></a>

### 3.1.9.5 Treatment

<a id="topic-3.1.9.5-1"></a>

#### Bepirovirsen or placebo arms

> “Participants will receive bepirovirsen.”
> “Participants will receive placebo.”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.5-2"></a>

#### 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.”

Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="heading-3.1.9.6"></a>

### 3.1.9.6 Study Outcomes

<a id="heading-3.1.9.6.1"></a>

#### 3.1.9.6.1 Rationale for Using HBV Virologic Response 36 Weeks After the End of Treatment as the Primary Endpoint

<a id="topic-3.1.9.6.1-1"></a>

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

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.6.1-2"></a>

##### 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”

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="topic-3.1.9.6.1-3"></a>

##### 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.”

Source: [Ghany et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12373085/)

<a id="heading-3.1.9.7"></a>

### 3.1.9.7 Statistical Analysis Description

<a id="heading-3.1.9.7.1"></a>

#### 3.1.9.7.1 Number of Participants (Planned and Analyzed)

<a id="topic-3.1.9.7.1-1"></a>

##### Enrollment in the registry record

| Field | Registry entry |
| --- | --- |
| Enrollment (actual) | “153” |

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504)

<a id="heading-3.1.9.7.2"></a>

#### 3.1.9.7.2 Description of Analysis Sets

No evidence found.

<a id="heading-3.1.9.8"></a>

### 3.1.9.8 Results

<a id="heading-3.1.9.8.1"></a>

#### 3.1.9.8.1 Participant Disposition

No evidence found.

<a id="heading-3.1.9.8.2"></a>

#### 3.1.9.8.2 Baseline Characteristics

No evidence found.

<a id="heading-3.1.9.8.3"></a>

#### 3.1.9.8.3 Efficacy Results

No evidence found.

<a id="heading-3.1.9.8.4"></a>

#### 3.1.9.8.4 Health-related Quality of Life and Patient-reported Outcomes

No evidence found.

<a id="heading-3.1.9.8.5"></a>

#### 3.1.9.8.5 Safety Results

No evidence found.

<a id="heading-3.1.9.9"></a>

### 3.1.9.9 Study Limitations

<a id="topic-3.1.9.9-1"></a>

#### 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.

Source: [ClinicalTrials.gov NCT06497504](https://clinicaltrials.gov/study/NCT06497504); [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

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