CCIFLDI 2021 will be held in Wuhan, Hubei Province in October 2021 in the form of online+offline. In the session of "Viral Hepatitis" thematic report, Professor Sang Hoon Ahn from School of Medicine, Yonsei University, Seoul, Korea delivered a thematic report on "New biomarkers in HBV treatment" and received an exclusive interview with "Liver Disease" during the session.
<Hepatology Digest>:What are the traditional biomarkers of HBV? What are the unmet clinical needs for the application of these markers?
Prof. Sang Hoon Ahn：Traditional serum markers of HBV are qualitative detection of HBV surface Antigen (HBsAg), antibody to HBV core antigen (anti-HBc), anti-HBs for diagnosis. In order to identify phase of chronic hepatitis B (CHB), serum HBV DNA, HBeAg and anti-HBe have been used, which reflect active viral replication.
These biomarkers are helpful for diagnosis and monitoring of acute or chronic hepatitis B. However, there are limitations in predicting clinical outcomes of disease or antiviral treatment. There has been a lack of predictive markers to guide clinical management and to allow treatment cessation with reduced risk of viral reactivation.
<Hepatology Digest>:What are the new biomarkers in HBV treatment? What are the characteristics of each?
Prof. Sang Hoon Ahn：New serum biomarkers of HBV infection include serum HBV RNA, hepatitis B core-related antigen (HBcrAg), quantified HBsAg (qHBsAg), quantified AHBc (qAHBc), HBV nucleic acid-related antigen (HBV-NRAg) and ultrasensitive HBsAg.
Among these new biomarkers, the following three makers have been widely studied. First, serum HBV RNA is likely a mixture of intact, pregenomic (pg) and subgenomic, spliced, truncated, and polyA-free species. Serum HBV RNA, particularly pgRNA, is the most direct measure of cccDNA transcriptional activity. Second, HBcrAg is represented by three separate proteins, HBeAg, HBV core antigen and p22cr. Recent data suggest that HBcrAg correlates well with intrahepatic cccDNA and its transcriptional activity. Lastly, qHBsAg measurement may better inform clinicians regarding response to treatment, prediction of sustained virologic response, and disease progression.
<Hepatology Digest>:What is the prospect of clinical application of new HBV biomarkers? What problems can be solved in HBV clinical?
Prof. Sang Hoon Ahn：Novel HBV biomarkers are in development in an effort to predict treatment response and disease outcome of CHB, and further understand natural history of HBV. Quantification of intrahepatic covalently closed circular DNA (cccDNA) is the gold standard for gaining a full understanding of HBV replicative and transcriptional activity. However, invasive procedures and a lack of standardization prevent this as routine prognostic HBV biomarkers. Novel biomarkers will more accurately reflect cccDNA without liver biopsy.
The role of novel HBV biomarkers will evolve with the advent of new treatment for CHB. Many new HBV drugs are under clinical trials. Monitoring of response to new therapies with novel biomarkers such as serum HBV RNA, qHBsAg, qHBeAg and HBcrAg are currently routine in clinical trials together with host immune markers if immune therapies are comibined. On the other hands, there are several limitations to widely use novel biomarkers in current clinical practice. Assays should be more standardized, commercialized and accessible worldwide. In addition, data from larger cohorts should be confirmed for clinical utility. I think no single HBV biomarkers will likely answer all clinical questions. As new HBV treatments, combination of these novel HBV biomarkers would predict more precisely treatment response and clinical outcome.
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