APPROACH AND RESULTS:
Biomarkers, including HBV
RNA and
hepatitis B core-related
antigen (HBcrAg), were measured in 388 patients. Of these, 246 were treatment-naïve and were categorized into
HBeAg-positive
chronic infection (n = 41),
HBeAg-positive
chronic hepatitis (n = 81),
HBeAg-negative
chronic infection (n = 39),
HBeAg-negative
chronic hepatitis (n = 66), and
HBsAg seroclearance (n = 19). These
biomarkers were also measured in 142 patients who were NA-treated receiving
tenofovir or
entecavir at baseline, week 48, and week 96. The pattern of serum HBV
RNA levels mirrored HBV
DNA (1-2 logs higher than HBV
RNA) and HBcrAg in patients who were treatment-naïve. HBV
RNA correlated best with HBcrAg (r = 0.84) and to a lesser extent with HBV
DNA (r = 0.737) (both P < 0.001). In patients with
HBsAg seroclearance, 15.8% and 15.8% had detectable serum HBV
RNA and HBcrAg, respectively. NA treatment reduced serum HBV
RNA by 1.46 logs and 1.77 logs at weeks 48 and 96, respectively. At week 96 of NA
therapy, only 19.1% patients who were
tenofovir-treated and 25.7% patients who were
entecavir-treated had unquantifiable HBV
RNA (P > 0.05). In patients who were treated and had undetectable HBV
DNA, 77.5% and 30% had quantifiable HBV
RNA and HBcrAg, respectively.
CONCLUSIONS: HBV
RNA showed distinct and corresponding profiles in patients with HBV in different disease phases. HBV
RNA and HBcrAg could be used to monitor residual transcriptional activities in patients with
HBsAg seroclearance. NA led to reduction of serum HBV
RNA. Monitoring of viral activities can still be achieved in patients with undetectable HBV
DNA by serum HBV
RNA.