--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Diagnosis" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Diagnosis. Topics: Serologic definition of chronic infection, Universal adult screening with the triple panel: CDC 2023 recommendations, Risk-based screening: USPSTF 2020 recommendation, Screening markers: EASL 2025 recommendation, and 4 further topics. 8 evidence topics quoted from 8 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/diagnosis" 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: Diagnosis ## 2.2.1.5 Diagnosis ### Serologic definition of chronic infection > “The presence of HBsAg establishes the diagnosis of hepatitis B. Chronic vs acute infection is defined by the presence of HBsAg for at least 6 months.” Source: [Terrault et al. (2018)](https://pmc.ncbi.nlm.nih.gov/articles/PMC5975958/) > “HBsAg: HBsAg is a protein on the surface of HBV that can be detected in high levels in serum during acute or chronic HBV infection.” > “The presence of total anti-HBc indicates previous or ongoing infection with HBV in an undefined time frame. People who have immunity to hepatitis B from a vaccine do not develop anti-HBc.” > “IgM anti-HBc positivity indicates recent infection with HBV (within less than 6 months). Its presence indicates acute infection.” Source: [CDC Clinical Testing and Diagnosis for Hepatitis B (2026)](https://www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/index.html) ### Universal adult screening with the triple panel: CDC 2023 recommendations > “New recommendations include hepatitis B screening using three laboratory tests at least once during a lifetime for adults aged ≥18 years.” > “Triple panel screening: Using the triple panel (HBsAg, anti-HBs, and total anti-HBc) is recommended for initial screening because it can help identify persons who have an active HBV infection and could be linked to care, have resolved infection and might be susceptible to reactivation (e.g., immunosuppressed persons), are susceptible and need vaccination, or are vaccinated.” > “Universal screening: Universal screening of adults is cost-effective compared with risk-based screening and averts liver disease and death (56).” Source: [Conners et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9997714/) > “Screen all adults aged 18 and older for hepatitis B at least once in their lifetime using a triple panel test. To ensure increased access to testing, anyone who requests HBV testing should receive it regardless of disclosure of risk.” Source: [CDC Clinical Testing and Diagnosis for Hepatitis B (2026)](https://www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/index.html) ### Risk-based screening: USPSTF 2020 recommendation > “Up to 60% of HBV-infected persons are unaware of their infection, and many remain asymptomatic until onset of cirrhosis or end-stage liver disease.” > “The USPSTF recommends screening for HBV infection in adolescents and adults at increased risk for infection. (B recommendation).” Source: [US Preventive Services Task Force (2020)](https://pubmed.ncbi.nlm.nih.gov/33320230/) ### Screening markers: EASL 2025 recommendation > “For initial screening of HBV infection, HBsAg and anti-HBc should be determined (strong recommendation, consensus).” > “Anti-HBs can provide valuable insights into vaccination status, particularly when both HBsAg and anti-HBc are negative, and can aid in risk stratification for HBVr in patients undergoing immunosuppressive treatment.” Source: [EASL (2025)](https://doi.org/10.1016/j.jhep.2025.03.018) ### Initial virologic evaluation of HBsAg-positive persons: HBeAg and HBV DNA > “After identifying a person with HBV infection, testing for HBeAg, anti-HBe, and HBV DNA can provide information on the level of viral replication and infectivity and help guide clinical management.” Source: [Conners et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9997714/) > “HBV DNA should be tested, as it serves as the most important prognostic marker and is critical for treatment indication and treatment monitoring” > “HBsAg quantification should be tested to characterize disease phase, define prognosis and guide treatment” > “HBeAg should be tested to define the disease phase” Source: [EASL (2025)](https://doi.org/10.1016/j.jhep.2025.03.018) ### Quantitative HBsAg: assays, thresholds, and role in phase classification and treatment endpoints > “Quantitative HBsAg cannot replace HBV DNA measurement but can provide additional value, such as helping to differentiate the phases of chronic HBV infection (see Table 4) and guiding treatment.” > “HBsAg levels should be determined every 12 months. If a quantitative determination of HBsAg is not possible, a qualitative HBsAg test is the minimum requirement (strong recommendation, strong consensus).” Source: [EASL (2025)](https://doi.org/10.1016/j.jhep.2025.03.018) > “The desire to assess covalently closed circular DNA (cccDNA) inside hepatocytes led to development of reproducible, automated, and standardized (IU/mL) assays (Architect QT assay [Abbott], Elecsys HBsAg III Quant [Roche], Liaison XL [DiaSorin]) to quantify hepatitis B surface antigen (109).” > “Although qHBsAg reflects covalently closed circular DNA and intrahepatic DNA levels, it also measures HBsAg that arises from integrated DNA, thereby reducing its specificity as a biomarker for viral replication.” > “In HBeAg-negative patients, low qHBsAg (<1,000 IU/mL) and low HBV DNA (≤2,000 IU/mL) suggest inactive CHB.” Source: [Terrault et al. (2018)](https://pmc.ncbi.nlm.nih.gov/articles/PMC5975958/) ### Assessment of fibrosis and cirrhosis: noninvasive methods and liver stiffness thresholds > “Non-invasive methods should be used to assess liver fibrosis and stage liver disease in all HBsAg-positive individuals (strong recommendation, strong consensus).” > “In an optimal setting, liver fibrosis is assessed using LSM, with defined cut-off values for VCTE indicating significant fibrosis (7.2-7.9 kPa), advanced fibrosis (8.8-9.4 kPa) and cirrhosis (≥11.7-12.2 kPa), as shown in two systematic reviews and meta-analyses focused on individuals with HBV infection.” > “Liver stiffness values <10 kPa were proposed as a safe cut-off for excluding cACLD and values >15 kPa as highly suggestive of cACLD.” > “Serum-based tests such as APRI and FIB-4 are widely available, but their accuracy in chronic HBV infection is limited.” Source: [EASL (2025)](https://doi.org/10.1016/j.jhep.2025.03.018) > “Elastography (e.g., FibroScan) or serum fibrosis assessment (e.g., APRI, FibroSure, FIB-4)” Source: [Conners et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9997714/) > “Alternative methods to assess fibrosis are elastography (preferred) and liver fibrosis biomarkers (eg, FIB-4 or FibroTest®).” Source: [Terrault et al. (2018)](https://pmc.ncbi.nlm.nih.gov/articles/PMC5975958/) ### Bepirovirsen patient selection: quantitative HBsAg testing and the FDA-authorized companion diagnostic > “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” > “Information on FDA-authorized tests for the quantification of HBsAg levels is available at:” > “rule out cirrhosis before initiating HIBSAGO” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) > “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.” Source: [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment) > “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.” Source: [GSK press release, Hibsago US approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/) ## Related pages - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Terms and abbreviations](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations.md) - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Product information and disease description](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Clinical evidence](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: new drug review](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: cost-effectiveness analyses and utility weights](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses.md)