---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Fine"
description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: B-Fine. Covers Objective, Location and study date, Study design, Eligibility criteria, Treatment, Study outcomes, and 3 further headings. 41 evidence topics quoted from 5 sources."
canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence/b-fine"
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-Fine

<a id="heading-3.1.7"></a>

## 3.1.7 B-Fine

<a id="heading-3.1.7.1"></a>

### 3.1.7.1 Objective

<a id="topic-3.1.7.1-1"></a>

#### Primary objective

> “Efficacy: To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with CHB”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.1-2"></a>

#### Mechanistic rationale

> “B-Fine is an exploratory study of the therapeutic mechanism of GSK3228836 in participants with chronic hepatitis B (CHB) on stable nucleos(t)ide therapy.”
> “Repeat fine needle aspirates of the liver will be performed to enable analysis of liver-resident immune cells to investigate any immunomodulatory properties of GSK3228836 and to study the biology of underlying treatment-associated liver flares.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.1-3"></a>

#### Study hypothesis

> “Study Hypothesis: GSK3228836 treatment will result in phenotypic changes in intrahepatic immunity associated with loss of HBsAg and treatment-emergent changes in ALT”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.1-4"></a>

#### Questions the mechanistic investigation addresses

> “To determine whether GSK3228836 has an immunomodulatory mechanism of action in addition to its previously described direct antiviral effects on HBV mRNA.”
> “To investigate the relationship between GSK3228836-mediated suppression of HBsAg, ALT flares and the potential for functional cure.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.1-5"></a>

#### Objective as registered

> “It will investigate the virologic and immunologic correlates of hepatitis B virus surface antigen (HBsAg) loss observed in participants when treated for 12 weeks with 300 milligrams (mg) GSK3228836.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="heading-3.1.7.2"></a>

### 3.1.7.2 Location and Study Date

<a id="topic-3.1.7.2-1"></a>

#### Registry record: identifiers, dates, enrollment, and locations

| Field | Quoted record |
| --- | --- |
| Other study identifier | “212602” |
| Study start (actual) | “2020-10-06” |
| Primary completion (actual) | “2023-11-30” |
| Enrollment (actual) | “12” |
| Number of listed locations | “This study has 4 locations” |
| Results first posted | “2024-12-19” |

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.2-2"></a>

#### Countries of the listed sites

> “Boston, Massachusetts, United States, 02114”
> “Toronto, Ontario, Canada, M5G 2C4”
> “Rotterdam, Netherlands, 3015 GD”
> “London, United Kingdom, E1 1BB”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.2-3"></a>

#### Regulatory identifiers and protocol approval date

> “EudraCT: 2020-002000-39”
> “Approval Date: 15-MAR-2021”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="heading-3.1.7.3"></a>

### 3.1.7.3 Study Design

<a id="topic-3.1.7.3-1"></a>

#### Phase IIa, multicentre, open-label, single-arm design with repeat liver fine needle aspiration

> “This study is a Phase IIa, multi-centre open label exploratory study of the therapeutic mechanism of GSK3228836 in participants with HBeAg-negative CHB on stable nucleos(t)ide therapy using repeat fine needle aspirations of the liver for intrahepatic immunophenotyping (see Section 1.2).”
> “After the 12 weeks of dosing with GSK3228836, there will be a post-treatment follow-up period of 24 weeks. An Independent Data Monitoring Committee (IDMC) will review the data (see Section 10.1.5).”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.3-2"></a>

#### Number and timing of fine needle aspirates

> “In study 212602, it is proposed to perform a total of 5 FNAs at preselected timepoints (plus up to 1 optional FNA) during the 45-week study duration (see Section 1.2).”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.3-3"></a>

#### Study duration and visit frequency

> “Study Duration: 37 weeks (45 weeks if include screening and flexible visit windows)”
> “Visit Frequency: Twice a week for the first 2 weeks, once a week through Week 14, once at Week 16, and once every 4 weeks thereafter”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.3-4"></a>

#### Registered design details

| Field | Quoted record |
| --- | --- |
| Allocation | “N/A” |
| Interventional model | “Single Group Assignment” |
| Model description | “A single arm, multi-center, open label exploratory study.” |
| Masking | “None (Open Label)” |

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="heading-3.1.7.4"></a>

### 3.1.7.4 Eligibility Criteria

<a id="topic-3.1.7.4-1"></a>

#### Key registered inclusion criteria

> “Participants should be at least 18 years of age at the time of signing the informed consent.”
> “Participants who have documented chronic HBV infection >=6 months prior to screening and currently receiving stable nucleos(t)ide analogue therapy, defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study.”
> “Plasma or serum HBsAg concentration >100 IU/mL”
> “Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.”
> “HBeAg-negative”
> “ALT less than or equal to (<=)2 times ULN”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.4-2"></a>

#### Key registered exclusion criteria

> “Liver biopsy showing Metavir 4 or equivalent”
> “Liver stiffness >12 kilopascals (kPa)”
> “Currently taking, or took within 12 months of screening, any interferon-containing therapy.”
> “Platelet count <140 times 10^9/liter (L)”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.4-3"></a>

#### Rationale for enrolling HBeAg-negative participants on NA therapy

> “In study 212602 (B-Fine), participants expected to have the highest chance of achieving HBsAg level <LLOQ with 12 weeks of treatment with GSK3228836 will be enrolled.”
> “As HBeAg-negative patients typically have lower levels of serum HBsAg than HBeAg-positive patients, the HBeAg-negative population has been selected for study 212602 in order to enrich for potential responders.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="heading-3.1.7.5"></a>

### 3.1.7.5 Treatment

<a id="topic-3.1.7.5-1"></a>

#### Bepirovirsen dose, loading doses, and duration

> “Participants on stable nucleos(t)ide therapy will receive GSK3228836 300 mg subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).”
> “GSK3228836 will be available as a clear colorless to slightly yellow solution for injection in 150 mg/milliliters (mL) vial to be administered SC once weekly.”
> “Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleos(t)ide therapy for the duration of the study.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.5-2"></a>

#### Rationale for 12 weeks of treatment

> “Twelve weeks duration of treatment with 300 mg GSK3228836 has been selected as optimal to assess the primary endpoint of achieving HBsAg < LLOQ in study 212602.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.5-3"></a>

#### Dose adjustments

> “There are no plans for dose adjustments.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="heading-3.1.7.6"></a>

### 3.1.7.6 Study Outcomes

<a id="heading-3.1.7.6.1"></a>

#### 3.1.7.6.1 Rationale for Using HBsAg Below the Lower Limit of Quantitation by Week 12 as the Primary Endpoint

<a id="topic-3.1.7.6.1-1"></a>

##### Primary endpoint and estimation approach

> “The primary endpoint is achieving serum HBsAg level <LLOQ by Week 12 (at any time point up to and including Week 12) without the use of PEG-interferon or other immunomodulator therapies in CHB participants who receive at least one dose of IP.”
> “An estimation approach with no hypothesis testing will be used to address the primary objective.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.6.1-2"></a>

##### HBsAg loss as the treatment endpoint in chronic hepatitis B

> “In both HBeAg-positive and HBeAg-negative CHB, the ultimate treatment endpoint is loss of detectable serum hepatitis B surface antigen (HBsAg) and serum HBV DNA [Lok, 2009; EASL, 2012].”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.6.1-3"></a>

##### Rationale from the phase 2a study for a longer treatment duration

> “Taken together, the data suggest that a longer duration of treatment with GSK3228836 may be required to increase the rate of participants achieving HBsAg levels <LLOQ.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.6.1-4"></a>

##### Registered primary outcome measure

> “Percentage of participants achieving serum HBsAg level <LLOQ were reported. Percentage values are rounded-off.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.6.1-5"></a>

##### Secondary endpoints: sustained HBsAg response and sustained virologic response

> “Sustained HBsAg response is defined as HBsAg <LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off.”
> “Sustained virologic response is defined as HBsAg <LLOQ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="topic-3.1.7.6.1-6"></a>

##### Secondary ALT endpoint: time to maximum ALT

> “Time to maximum ALT (maximum peak in ALT) during 36 week (treatment + follow-up) is defined as time from Baseline to the time of first peak in ALT.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956)

<a id="heading-3.1.7.7"></a>

### 3.1.7.7 Statistical Analysis Description

<a id="heading-3.1.7.7.1"></a>

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

<a id="topic-3.1.7.7.1-1"></a>

##### Planned enrollment

> “Number of Participants: The study will enrol approximately 20 participants, but no more than 24.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.7.1-2"></a>

##### Bayesian operating characteristics for 20 participants

> “With a sample size of 20 participants, if there are at least 12 participants achieving HBsAg <LLOQ (observed percent of 60%) then the posterior probability that the true percent is greater than 50% will be greater than 75%.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.7.1-3"></a>

##### Conditions for increasing the sample size

> “In certain cases, including but not limited to higher than anticipated drop-out rate, higher than anticipated rates of efficacy, or large variability in ALT flare patterns, the sample size may be increased to no more than 24.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.7.1-4"></a>

##### Participants enrolled and analyzed

> “A total of 12 participants were enrolled in this study.”
> “Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="heading-3.1.7.7.2"></a>

#### 3.1.7.7.2 Description of Analysis Sets

<a id="topic-3.1.7.7.2-1"></a>

##### Protocol analysis sets

| Analysis set | Quoted description |
| --- | --- |
| Intent to Treat (ITT) | “All participants who received at least one dose of study treatment” |
| Pharmacokinetic (PK) | “All participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values will be considered as non-missing values)” |
| Pharmacodynamic (PD) | “All participants in the Safety population for whom a Pharmacodynamic sample was obtained and analyzed.” |
| Analysis set for primary estimand | “All Intent to Treat Participants including all observations on and off treatment.” |

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.7.2-2"></a>

##### Handling of intercurrent events and immunomodulator use

> “Intercurrent events: Discontinuation of, interruption of, and adherence to IP will be ignored (treatment policy).”
> “If PEG-interferon or other immunomodulator therapies are used, then the participant’s primary outcome will be treated as a failure.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.7.2-3"></a>

##### Primary analysis: point estimate with 95% credible interval

> “Point estimate of the percentage as well as the 95% credible interval (Highest Density Interval, HDI) of participants achieving serum HBsAg level <LLOQ by Week 12 will be provided.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

<a id="topic-3.1.7.7.2-4"></a>

##### Safety population in the registry results

> “All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="heading-3.1.7.8"></a>

### 3.1.7.8 Results

<a id="heading-3.1.7.8.1"></a>

#### 3.1.7.8.1 Participant Disposition

<a id="topic-3.1.7.8.1-1"></a>

##### Registry participant flow

| Disposition | Bepirovirsen 300 mg |
| --- | --- |
| Started | “12” |
| Completed | “11” |
| Not completed | “1” |
| Reason not completed | “Withdrawal by Subject” |

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="heading-3.1.7.8.2"></a>

#### 3.1.7.8.2 Baseline Characteristics

<a id="topic-3.1.7.8.2-1"></a>

##### Age

> “48.8(8.48)”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="topic-3.1.7.8.2-2"></a>

##### Sex and race reported only as a de-identified category

> “Gender categories (with 0<n<11) are combined into one 'De-identified' category to maintain participant confidentiality and privacy, as they could lead to participant re-identification.”
> “Race categories (with 0<n<11) are combined into one 'De-identified' category to maintain participant confidentiality and privacy, as they could lead to participant re-identification.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="heading-3.1.7.8.3"></a>

#### 3.1.7.8.3 Efficacy Results

<a id="topic-3.1.7.8.3-1"></a>

##### Primary and sustained response endpoints

| Endpoint | Participants analyzed | Percentage of participants |
| --- | --- | --- |
| HBsAg <LLOQ up to Week 12 (primary) | “12” | “25” |
| Sustained HBsAg response for 24 weeks after planned end of treatment | “12” | “8” |
| Sustained HBsAg response for 24 weeks after actual end of treatment | “12” | “8” |
| Sustained virologic response for 24 weeks after planned end of treatment | “12” | “8” |
| Sustained virologic response for 24 weeks after actual end of treatment | “12” | “8” |

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="topic-3.1.7.8.3-2"></a>

##### Time to maximum ALT

> “(27.1 to NA)”
> “NA indicates median and 95% CI (upper limit) could not be derived, as <50% of participants experienced the event within the treatment arm.”

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="topic-3.1.7.8.3-3"></a>

##### Intrahepatic and peripheral immunophenotyping presented at AASLD 2025

> “Intrahepatic immunophenotyping of participants with chronic hepatitis B receiving bepirovirsen in the B-Fine study reveals diverse changes in immunological status”
> “Intrahepatic and peripheral immunophenotyping of participants with chronic hepatitis B receiving bepirovirsen in the B-Fine study strongly suggests that bepirovirsen may trigger a humoral response”

Source: [GSK press release, AASLD 2025 (2025)](https://www.gsk.com/en-gb/media/press-releases/gsk-presents-data-from-its-advancing-liver-pipeline-at-aasld-2025/)

<a id="heading-3.1.7.8.4"></a>

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

No evidence found.

<a id="heading-3.1.7.8.5"></a>

#### 3.1.7.8.5 Safety Results

<a id="topic-3.1.7.8.5-1"></a>

##### Mortality, serious adverse events, and other adverse events

| Event | Affected / at risk (%) |
| --- | --- |
| All-cause mortality | “0/12 (0.00%)” |
| Serious adverse events, total | “0/12 (0.00%)” |
| Other adverse events, total | “11/12 (91.67%)” |
| Injection site erythema | “7/12 (58.33%)” |
| Injection site pruritus | “4/12 (33.33%)” |
| Procedural pain | “3/12 (25.00%)” |
| Injection site pain | “2/12 (16.67%)” |
| Pyrexia | “2/12 (16.67%)” |
| Fatigue | “2/12 (16.67%)” |
| Headache | “2/12 (16.67%)” |
| Alanine aminotransferase increased | “1/12 (8.33%)” |
| Hypertransaminasaemia | “1/12 (8.33%)” |
| Platelet count decreased | “1/12 (8.33%)” |
| Creatinine renal clearance decreased | “1/12 (8.33%)” |

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results)

<a id="heading-3.1.7.9"></a>

### 3.1.7.9 Study Limitations

<a id="topic-3.1.7.9-1"></a>

#### Summary: study limitations

B-Fine was an open-label study without a control group: all 12 enrolled participants received bepirovirsen 300 mg, against a planned enrollment of approximately 20, and 11 completed. Enrollment was restricted to HBeAg-negative participants on stable NA therapy in order to “enrich for potential responders”, and treatment lasted 12 weeks, while the approved label sets a maximum recommended treatment duration of 24 weeks. The protocol's operating criterion was at least 12 of 20 participants (60%) reaching HBsAg below the LLOQ by week 12; the registry reports 25% for the primary endpoint and 8% for sustained HBsAg response 24 weeks after treatment. Sex and race were reported only as a de-identified category, and the intrahepatic immunophenotyping results are described in the GSK AASLD 2025 release only by poster titles.

Source: [ClinicalTrials.gov NCT04544956](https://clinicaltrials.gov/study/NCT04544956?tab=results); [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf); [GSK press release, AASLD 2025 (2025)](https://www.gsk.com/en-gb/media/press-releases/gsk-presents-data-from-its-advancing-liver-pipeline-at-aasld-2025/); [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF)

<a id="topic-3.1.7.9-2"></a>

#### Exploratory design without hypothesis testing

> “An estimation approach with no hypothesis testing will be used to address the primary objective.”

Source: [GSK 212602 protocol (2021)](https://cdn.clinicaltrials.gov/large-docs/56/NCT04544956/Prot_000.pdf)

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