Abstract
A comprehensive characterization of chronic HBV (CHB) patients is required to guide therapeutic decisions. The cumulative impact of classical and novel biomarkers on the clinical categorization of these patients has not been rigorously assessed. We determined plasma HBV-RNA and HBsAg levels, HBV in peripheral lymphocytes (PBMCs) and HBV mutation profiles in CHB patients. Patient demographics (n = 139) and classical HBV biomarkers were determined during a clinical routine. HBV-RNA in plasma and HBV-DNA in PBMCs were determined by RT-PCR. HBsAg levels were determined using Architect. In samples with HBV-DNA viral load >1000 IU/mL, genotype mutations in precore (PC), basal core promoter (BCP), HBsAg and Pol regions were determined by sequencing. Most patients (n = 126) were HBeAg-negative (HBeAgNeg) with significantly lower levels of HBV-RNA, HBV-DNA and HBsAg compared to HBeAg-positive (HBeAgPos) patients (p < 0.05). HBV genotype D prevailed (61/68), and >95% had BCP/PC mutations. Escape mutations were identified in 22.6% (13/63). HBeAgNeg patients with low levels of HBsAg (log IU ≤ 3) were older and were characterized by undetectable plasma HBV-DNA and undetectable HBV-RNA but not undetectable HBV-DNA in PBMCs compared to those with high HBsAg levels. In >50% of the studied HBeAgNeg patients (66/126), the quantitation of HBsAg and HBV-RNA may impact clinical decisions. In conclusion, the combined assessment of classical and novel serum biomarkers, especially in HBeAgNeg patients, which is the largest group of CHB patients in many regions, may assist in clinical decisions. Prospective studies are required to determine the real-time additive clinical advantage of these biomarkers.
Highlights
These include plasma HBV-DNA, the viral secreted antigens HBsAg and HBeAg, liver enzymes, in combination with a non-invasive assessment of liver fibrosis [4]
139 chronic HBV (CHB) patients were recruited for the study (Table 1), most of whom were male
The value of several novel non-invasive biomarkers in CHB patients has already been demonstrated in numerous studies [20]
Summary
As the clinical course of CHB is variable, several classical non-invasive serum biomarkers, which reflect the status of HBV in the liver, have been introduced These include plasma HBV-DNA (which reflects viral proliferation), the viral secreted antigens HBsAg (an embedded viral protein that is related to the viral envelope) and HBeAg (a pre-core protein), liver enzymes (alanine aminotransferase, ALT, and aspartate transaminase, AST, which are elevated in chronic HBV hepatitis patients), in combination with a non-invasive assessment of liver fibrosis [4]. We determined levels of HBV-RNA and HBsAg in plasma, quantified HBV-DNA in lymphocytes, and analyzed HBV escape, resistance, and precore/core mutations; we combined the results of these parameters with data collected on classical biomarkers from a cohort of both CHB treatment-naïve and treated patients in Israel. The potential value of these markers was assessed in the aspect of personalized medicine
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