Product information and disease description Place of product in therapy Approaches to treatment

Place in treatment, anticipated use, and care setting

9 evidence topics · 7 sources

Summary: anticipated place in therapy

The label indicates bepirovirsen “in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy” for adults without cirrhosis who have received NrtI therapy for at least 6 months, have suppressed HBV DNA, and have HBsAg levels of 3,000 IU/mL or less by an FDA-authorized test, with a maximum treatment duration of 24 weeks. Its anticipated position is therefore among virologically suppressed adults already receiving entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide, the three nucleos(t)ide analogues the AASLD/IDSA guideline lists as preferred. The AASLD/IDSA and EASL 2025 guidelines both identify HBsAg loss (functional cure) as the desired treatment endpoint, and the AASLD/IDSA guideline states that updated guidelines can be anticipated “as new therapies are FDA-approved”. The label requires the initial dose to be given under healthcare provider supervision, permits patient or caregiver self-administration thereafter, and requires laboratory monitoring before, during, and after treatment; analysts quoted by Fierce Pharma stated that the monitoring burden “could slow adoption outside specialist hepatology centers.” In the pivotal trials, the functional cure rate was 19% (233 of 1,220) overall and 26% (200 of 768) in participants with baseline HBsAg of 1,000 IU/mL or less, a group GSK states represents “approximately 45% of diagnosed CHB cases globally”.

Labeled population

“HIBSAGO is indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis:” (opens the prescribing information at this quote)
“who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and” (opens the prescribing information at this quote)
“who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test” (opens the prescribing information at this quote)
“Prior to initiation of HIBSAGO for treatment of chronic HBV infection, test all patients to quantify HBsAg levels in serum or plasma to identify patients with baseline HBsAg levels less than or equal to 3,000 IU/mL” (opens the prescribing information at this quote)

Regulator description of the approved population and companion diagnostic

“Hibsago is approved for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test.” (opens the source at this quote in a new tab)
“The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic device to aid in the selection of patients with chronic HBV infection for treatment with antiviral therapy in accordance with the FDA approved drug labeling and to assist in monitoring patients throughout the course of treatment.” (opens the source at this quote in a new tab)
“Patients take it alongside their existing hepatitis B medicine and continue that medicine for at least 24 weeks after their last Hibsago injection. Some patients may then be able to stop their existing medicine if they meet certain health and lab test requirements.” (opens the source at this quote in a new tab)

Care setting and administration requirements in the label

“HIBSAGO therapy should be prescribed only when appropriate laboratory monitoring can be performed to manage the treatment regimen.” (opens the prescribing information at this quote)
“HIBSAGO must be administered under the guidance and supervision of a healthcare provider for the initial dose to ensure proper injection technique.” (opens the prescribing information at this quote)
“Patients or caregivers may administer HIBSAGO after their healthcare provider determines that it is appropriate and with medical follow-up, including laboratory testing.” (opens the prescribing information at this quote)
“The maximum recommended duration of HIBSAGO treatment is 24 weeks” (opens the prescribing information at this quote)

Manufacturer statements on intended population, testing, and administration

“Quantitative surface antigen testing will support the diagnosis and identification of patients suitable for treatment with bepirovirsen who have baseline HBsAg levels ≤3000 IU/ml. Several tests are available, including a recently authorised FDA test.” (opens the source at this quote in a new tab)
“For the first time, with Hibsago, US patients have the potential to achieve functional cure after a six-month treatment course, with the added convenience of the option of self-administration after the first dose.” (opens the source at this quote in a new tab)
“Pooled data from the B-Well phase III trials showed that six-month treatment with bepirovirsen achieved a clinically meaningful 19% functional cure response rate (233 of 1,220 vs. 0 of 614 in the placebo group).” (opens the source at this quote in a new tab)
“In a key secondary endpoint, a functional cure rate of 26% (200 of 768 vs. 0 of 393 in the placebo group) was achieved in participants with ≤1000 IU/ml HBsAg level, a group that represents approximately 45% of diagnosed CHB cases globally.” (opens the source at this quote in a new tab)

Launch timing and anticipated uptake by care setting

“Hibsago should be made available to U.S. patients before the end of the year, a GSK spokesperson told Fierce, adding that the drug’s list price will become public once pricing and reimbursement discussions have wrapped with payers.” (opens the source at this quote in a new tab)
“The analysts also spotlighted Hibsago's black box warning for both hepatic flares and thrombocytopenia, noting that the subsequent every-other-week or weekly monitoring burden patients will face could in turn "work against the commercial uptake and could slow adoption outside specialist hepatology centers."” (opens the source at this quote in a new tab)

Functional cure as a treatment goal: AASLD/IDSA 2025 guideline

“Increasingly, there is emphasis on the achievement of HBsAg loss as the desired endpoint for treatment (functional cure), because of its association with reduction in clinical outcomes and long-term durability” (opens the source at this quote in a new tab)
“As the field of HBV therapeutics is robust and new drug therapies focused on functional cure are anticipated, updated guidelines can be anticipated as new therapies are FDA-approved.” (opens the source at this quote in a new tab)

Functional cure as a treatment goal: EASL 2025 guideline

“Loss of HBsAg (post therapy) is the ultimate goal of treatment, is the defining feature of functional cure of HBV infection” (opens the source at this quote in a new tab)
“Several novel compounds with distinct mechanisms of action are currently in advanced clinical development.” (opens the source at this quote in a new tab)
“These differences may also hold significant relevance as NAs form the backbone of novel therapeutic strategies aimed at achieving HBV functional cure.” (opens the source at this quote in a new tab)

Target population and role of nucleos(t)ide analogues in finite-therapy trials: 2022 AASLD-EASL endpoints conference

“Clinical trials should initially focus on patients with HBeAg-positive or negative chronic hepatitis B, who are treatment-naïve or virally suppressed on nucleos(t)ide analogues.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“As the only approved class of oral antiviral for CHB and the standard-of-care therapy for a majority of patients, NAs will have an important role to play in combination with novel agents in development because of their potency in inhibiting the production of new HBV DNA containing virions, and their well-characterized long-term safety profiles.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote