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-naïve 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.