Characterization and clinical application of a monoclonal antibody to hepatitis B virus large surface proteins

The pre-S domain of large surface proteins (LHBs) is thought to be associated with the infectious and sub-infectious particles of hepatitis B virus (HBV), and the quantitative measurement of the LHBs has become the critical serological assay for management of chronic HBV hepatitis. Here, we generated a monoclonal antibody with improved specificity and efficacy for both the native form and the glycosylated, full-length recombinant pre-S large protein, and tested it in clinical applications. We recruited 573 HBV patients and detect HBV large envelope proteins and the circulating viral load. We then studied the relationship between LHBs and HBV DNA in follow-up studies of 78 patients who received Adefovir antiviral treatment. We found that there was no significant difference between the rate of positive HBV DNA and the rate of positive LHBs. The levels of both HBV DNA and LHBs declined during the antiviral treatment, although the levels of LHBS decline later than the level of viremia.do. Furthermore, patients with 18 consecutive months of positive LHBs were able to obtain HBV DNA conversion, even if they continued to receive the antiviral treatment. Our study demonstrates that the level of LHBs can efficiently reflect the replication status of the virus in patients with HBeAg-negative diseases, and the LHB assay support the HBV test. Furthermore, examining the combination of LHBs and HBV DNA has important clinical implications for monitoring the effectiveness of the antiviral treatments.