Profiles of HBV DNA in a large population of Chinese patients with chronic hepatitis B: Implications for antiviral therapy

Background & Aims: We determined the virological profile in Chinese chronic hepatitis B (CHB) subjects and its implications regarding current treatment guidelines. Methods: A total of 1400 treatment-naive CHB patients had their HBV DNA levels determined using the Cobas Taqman assay. Patient demographics, HBeAg status, and liver biochemistry were also recorded. Results:The subjects were predominantly male (62%), had a median age of 45 years, and 301 (22%) were HBeAg-positive. In subjects aged <= 25, 26-35, 36-45, 46-55, and >55 years, there was a decreasing trend of HBV DNA levels of 9.9, 9.3, 8.2, 7.4, and 7.3 log copies/ml, respectively (p<0.001), in HBeAg-positive subjects, while the pattern was reversed with HBV DNA levels of 3.7, 4.4, 4.7, 4.9, and 5.2 log copies/ml, respectively, in HBeAg-negative subjects (p<0.001). In HBeAg-negative subjects, the proportion of patients with elevated ALT compared to those with normal ALT was significantly higher in older age groups (p<0.001). In our study population, by applying the AASLD, EASL, and APASL guidelines, 64%, 99%, and 64% would be eligible for antiviral therapy, respectively, in HBeAg-positive patients (with elevated ALT), and 38%, 72%, and 43%, respectively, in HBeAg-negative patients (with elevated ALT). Up to 54% of patients over the age of 40 years would be recommended for liver biopsy to determine further eligibility for treatment. Conclusions: For HBeAg-negative CHB, more patients had elevated ALT and a higher viral load with increasing age. Close monitoring is recommended in this group so that treatment may be considered. By applying the current treatment guidelines, a wide discrepancy can be observed in the proportion of patients eligible for treatment in the absence of histological data. (C) 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.