A critique and systematic review of the clinical utility of hepatitis B core-related antigen

Adraneda, Celina; Tan, Yong Chuan; Yeo, Ee Jin; Kew, Guan Sen; Khakpoor, Atefeh; Lim, Seng Gee

doi:10.1016/j.jhep.2022.12.017

Cited by 15 publications

(8 citation statements)

References 90 publications

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“…Based on these data, HBcrAg is not completely equivalent to HBV DNA for the management of patients during and off NA therapy. Our findings are in line with a recently published meta-analysis focusing on the clinical utility of HBcrAg in chronic HBV infection [ 24 ]. In their analyses, Adraneda et al calculated a false positive and negative rate for the assay of 9% and 12–35%, respectively.…”

Section: Discussionsupporting

confidence: 91%

“…The limitations of measuring HBcrAg have been discussed previously [ 24 ], and we have shown that quantification of HBcrAg during treatment is limited for the evaluation of treatment efficacy as well as for the detection of virologic relapse after NA discontinuation. Nevertheless, the clinical utility for determining treatment indication in the absence of quantitative HBV DNA has been demonstrated [ 19 ], which is a particularly important role in countries with limited access to healthcare resources.…”

Section: Discussionmentioning

confidence: 99%

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Kinetics and Value of Hepatitis B Core-Related Antigen in Patients with Chronic Hepatitis B Virus Infection during Antiviral Treatment

Sandmann,

Bremer,

Ohlendorf

et al. 2024

Viruses

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Background: The hepatitis B core-related antigen (HBcrAg) correlates with HBV DNA in patients with chronic HBV infection without antiviral treatment. Its utility in monitoring patients during and after the cessation of nucleos(t)ide analog (NA) treatment is unknown. Methods: The levels of HBcrAg were longitudinally determined in two cohorts of chronic HBV-infected patients with (A) newly started NA treatment or (B) after NA cessation during a median follow up (FU) of 60 months or 48 weeks, respectively. The correlation of HBcrAg and HBV DNA and the predictive value for HBeAg seroconversion and HBsAg loss were evaluated. Results: Fifty-six patients with newly-started NA treatment and 22 patients with NA cessation were identified. HBcrAg and HBV DNA strongly correlated before NA treatment (r = 0.77, p < 0.0001) and at virological relapse (0.66, p = 0.0063). At the individual level, the discrepant kinetics of HBcrAg and HBV DNA became evident. During NA treatment, 33% (6/18) and 9% (5/56) of patients showed HBeAg seroconversion or HBsAg loss/HBsAg < 100 IU/mL, respectively. Low levels of HBcrAg were associated with these endpoints. Conclusion: HBcrAg levels before antiviral treatment help to identify patients with chances of HBsAg loss or HBeAg seroconversion. However, its utility in replacing quantitative HBV DNA to evaluate treatment efficacy or virological relapse off-treatment is limited.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Kinetics and Value of Hepatitis B Core-Related Antigen in Patients with Chronic Hepatitis B Virus Infection during Antiviral Treatment

Sandmann,

Bremer,

Ohlendorf

et al. 2024

Viruses

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“…Samples with HBcrAg above 7 log U/mL are diluted and retested to detect the quantitative level of HBcrAg [ 42 ]. Notably, the relative contribution of each HBcrAg component in current commercial kit testing is unknown and may be influenced by factors such as viral genotype and HBeAg status, which may affect the accuracy and significance of HBcrAg as a biomarker [ 43 ]. Studies have shown that HBeAg is the main component of HBcrAg in HBeAg-positive patients (71.98 ± 10.24%), while HBcAg and p22cr only account for 17.64 ± 8.84% and 15.80 ± 9.13% of HBcrAg, respectively [ 44 ].…”

Section: Serum Hbcrag Can Reflect the Transcription Level Of Intrahep...mentioning

confidence: 99%

Quantitative Measurement of Serum HBcrAg Can Be Used to Assess the Feasibility of Safe Discontinuation of Antiviral Therapy for Chronic Hepatitis B

Wang,

Tang,

Chen

2024

Viruses

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Hepatitis B virus (HBV) infection is a serious global health problem, and chronic HBV infection significantly increases the risk of liver fibrosis, cirrhosis, and even hepatocellular carcinoma in patients. Current first-line therapeutics such as nucleos(t)ide analogues and interferons are unable to completely clear cccDNA, so the vast majority of patients need to take long-term or even lifelong medication. However, long-term virological and biochemical responses can be achieved in some patients after drug withdrawal. Successfully screening these patients with drug withdrawal advantages is difficult. Hepatitis-B-core-related antigen (HBcrAg) is a new HBV serological marker that which can reflect the level and transcription activity of cccDNA in hepatocytes. Therefore, HBcrAg has potential value in guiding patients in drug withdrawal. This review summarizes previous reports on HBcrAg and evaluates the application value of HBcrAg in safe drug discontinuation.

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“…The additional clinical significance of the HBcrAg assay in CHB is not yet fully understood [83]. Also, as the false-positive rate in CHB is 9.3% and the false-negative rate is 12-35%, caution is considered necessary in interpreting the results [89].…”

Section: Hbcrag and Antiviral Therapymentioning

confidence: 99%

Clinical Significance and Remaining Issues of Anti-HBc Antibody and HBV Core-Related Antigen

Yano,

Sato,

Imanishi

et al. 2024

Diagnostics

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Currently, hepatitis B virus (HBV) core antibody (anti-HBc antibody) and HBV core-related antigen (HBcrAg) are widely used as serum markers for diagnosis based on the HBV core region. This review focused on anti-HBc antibodies and HBcrAg and aimed to summarize the clinical significance of currently used assay systems and the issues involved. While anti-HBc is very significant for clinical diagnosis, the clinical significance of quantitative assay of anti-HBc antibody has been reevaluated with improvements in diagnostic performance, including its association with clinical stage and prediction of carcinogenesis and reactivation. In addition, concerning the new HBcrAg, a high-sensitivity assay method has recently been established, and its diagnostic significance, including the prediction of reactivation, is being reevaluated. On the other hand, the quantitative level of anti-HBc antibody expressed in different units among assay systems complicates the interpretation of the results. However, it is difficult to standardize assay systems as they vary in advantages, and caution is needed in interpreting the assay results. In conclusion, with the development of highly sensitive HBcrAg and anti-HBc antibody, a rapid and sensitive detection assay system has been developed and used in clinical practice. In the future, it is hoped that a global standard will be created based on the many clinical findings.

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A critique and systematic review of the clinical utility of hepatitis B core-related antigen

Cited by 15 publications

References 90 publications

Kinetics and Value of Hepatitis B Core-Related Antigen in Patients with Chronic Hepatitis B Virus Infection during Antiviral Treatment

Kinetics and Value of Hepatitis B Core-Related Antigen in Patients with Chronic Hepatitis B Virus Infection during Antiviral Treatment

Quantitative Measurement of Serum HBcrAg Can Be Used to Assess the Feasibility of Safe Discontinuation of Antiviral Therapy for Chronic Hepatitis B

Clinical Significance and Remaining Issues of Anti-HBc Antibody and HBV Core-Related Antigen

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