Abstract
Even though an approved vaccine for hepatitis B virus (HBV) is available and widely used, over 257 million individuals worldwide are living with chronic hepatitis B (CHB) who require monitoring of treatment response, viral activity, and disease progression to reduce their risk of HBV-related liver disease. There is currently a lack of predictive markers to guide clinical management and to allow treatment cessation with reduced risk of viral reactivation. Novel HBV biomarkers are in development in an effort to improve the management of people living with CHB, to predict disease outcomes of CHB, and further understand the natural history of HBV. This review focuses on novel HBV biomarkers and their use in the clinical setting, including the description of and methodology for quantification of serum HBV RNA, hepatitis B core-related antigen (HBcrAg), quantitative hepatitis B surface antigen (qHBsAg), including ultrasensitive HBsAg detection, quantitative anti-hepatitis B core antigen (qAHBc), and detection of HBV nucleic acid-related antigen (HBV-NRAg). The utility of these biomarkers in treatment-naïve and treated CHB patients in several clinical situations is further discussed. Novel HBV biomarkers have been observed to provide critical clinical information and show promise for improving patient management and our understanding of the natural history of HBV.
Highlights
It is estimated that over 257 million people are chronically infected with hepatitis B virus (HBV) worldwide and over 880,000 annual deaths are the result of hepatitis B-related outcomes such as hepatocellular carcinoma (HCC) and liver cirrhosis [1]
This study found that liver closed circularDNA (cccDNA), collected via biopsy, correlated better with serum HBV DNA than RNA and no correlation was found between cccDNA
In a study by Mak et al, among 142 nucleos(t)ide analogue (NA)-treated patients, 77.5% still had detectable serum HBV RNA after 96 weeks of treatment and HBV RNA levels correlated with hepatitis B core-related antigen (HBcrAg) and quantitative hepatitis B surface antigen (qHBsAg) [39]
Summary
It is estimated that over 257 million people are chronically infected with hepatitis B virus (HBV) worldwide and over 880,000 annual deaths are the result of hepatitis B-related outcomes such as hepatocellular carcinoma (HCC) and liver cirrhosis [1]. Quantification of novel and traditional serum HBV markers is being investigated as a surrogate of cccDNA, to circumvent the need for a liver biopsy to measure viral transcriptional activity, and to provide additional information on the state of disease, allow for more refined guidance in the clinical management of hepatitis B, and improve our understanding of HBV natural history. AHBc (qAHBc), and the detection of HBV nucleic acid-related antigen (HBV-NRAg) These markers have shown clinical utility in many studies, including with both treatment-naïve and treated chronic hepatitis B (CHB) patients. This clinical utility and the methods by which the novel HBV biomarkers are measured are the focus of this review
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