Role of Biomarkers in Guiding Cure of Viral Hepatitis B

Abstract

Chronic hepatitis B (CHB) virus infection is a global public health threat affecting approximately 257 million individuals worldwide. Hepatitis B surface antigen (HBsAg) loss has been the classic endpoint to define functional cure and decrease the large pool of individuals with CHB. Current treatments with nucleos(t)ide analogues persistently suppress hepatitis B virus (HBV) deoxyribonucleic acid in most CHB patients, but rarely achieve functional cure. New viral biomarkers, such as quantitative HBsAg, hepatitis B core-related antigen, and HBV ribonucleic acid, and combinations of these markers have the potential role of guiding HBV cure by enabling selection of the best candidates for therapy, identifying individuals with a higher likelihood of achieving HBsAg loss, and helping in the design of studies with new drugs. However, some of the assays used to analyze these markers require standardization and improvements in the level of detection. Analysis of host biomarkers to assess the host immune response to HBV is also important, as the natural course of CHB is determined by the interplay between viral replication and the immune response. These biomarkers are, however, in an early phase of development.

Optimal management of chronic hepatitis B patients receiving nucleos(t)ide analogues

“…3 HBsAg levels are higher in HBeAg-positive than HBeAg-negative patients and in HBV A and E genotypes. 3 Liver biopsy is still considered the gold standard for assessing necroinflammation and fibrosis. Nevertheless, the invasive nature of this procedure limits its indications.…”

“…Several HBV biomarkers such as quantitative HBsAg (qHBsAg), HBV‐RNA and hepatitis B core‐related antigen (HBcrAg) have potential implications in the natural history and diagnosis of the infection and in monitoring the response to therapy. The largest experience is with qHBsAg, a commercially available test that has been shown to be useful for classifying the various phases of infection . HBsAg levels are higher in HBeAg‐positive than HBeAg‐negative patients and in HBV A and E genotypes …”

“…The largest experience is with qHBsAg, a commercially available test that has been shown to be useful for classifying the various phases of infection . HBsAg levels are higher in HBeAg‐positive than HBeAg‐negative patients and in HBV A and E genotypes …”

Editorial: biomarkers in HBV and prediction of treatment response

“…Hepatitis B cure is clinically defined as persistently undetectable HBsAg and hepatitis B virus (HBV) DNA in serum, with or without seroconversion to hepatitis B surface antibody (anti‐HBs). Several definitions of HBV cure have been proposed, based on laboratory findings 1,2 . Prediction of treatment response is a key issue in HBV management.…”

“…Baseline and on‐treatment predictors are needed as stopping rules, especially for pegylated interferon (Peg‐IFN). Several new biomarkers such as HBV RNA, quantitative HBsAg (qHBsAg) and quantitative HBV core‐related antigen (qHBcrAg) have been evaluated to predict HBeAg and HBsAg loss and relapse after cessation of nucleos(t)ide analogues (NAs) 1,2 …”