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.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“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.” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)
“IgM anti-HBc positivity indicates recent infection with HBV (within less than 6 months). Its presence indicates acute infection.” (opens the source at this quote in a new tab)

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.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“Universal screening: Universal screening of adults is cost-effective compared with risk-based screening and averts liver disease and death (56).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

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

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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“The USPSTF recommends screening for HBV infection in adolescents and adults at increased risk for infection. (B recommendation).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Screening markers: EASL 2025 recommendation

“For initial screening of HBV infection, HBsAg and anti-HBc should be determined (strong recommendation, consensus).” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)

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.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“HBV DNA should be tested, as it serves as the most important prognostic marker and is critical for treatment indication and treatment monitoring” (opens the source at this quote in a new tab)
“HBsAg quantification should be tested to characterize disease phase, define prognosis and guide treatment” (opens the source at this quote in a new tab)
“HBeAg should be tested to define the disease phase” (opens the source at this quote in a new tab)

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

“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).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“In HBeAg-negative patients, low qHBsAg (<1,000 IU/mL) and low HBV DNA (≤2,000 IU/mL) suggest inactive CHB.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

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).” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)
“Liver stiffness values <10 kPa were proposed as a safe cut-off for excluding cACLD and values >15 kPa as highly suggestive of cACLD.” (opens the source at this quote in a new tab)
“Serum-based tests such as APRI and FIB-4 are widely available, but their accuracy in chronic HBV infection is limited.” (opens the source at this quote in a new tab)

“Elastography (e.g., FibroScan) or serum fibrosis assessment (e.g., APRI, FibroSure, FIB-4)” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Alternative methods to assess fibrosis are elastography (preferred) and liver fibrosis biomarkers (eg, FIB-4 or FibroTest®).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

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” (opens the prescribing information at this quote)
“Information on FDA-authorized tests for the quantification of HBsAg levels is available at:” (opens the prescribing information at this quote)
“rule out cirrhosis before initiating HIBSAGO” (opens the prescribing information at this quote)

“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)

“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)