Assessment of hepatitis B virus pregenomic RNA in high and low viremic chronic hepatitis B patients

Clin Exp Hepatol. 2021 Mar;7(1):85-92. doi: 10.5114/ceh.2021.104472. Epub 2021 Mar 25.

Abstract

Aim of the study: Intrahepatic covalently closed circular DNA (cccDNA) is the main cause of hepatitis B virus (HBV) persistence. Therefore, a noninvasive serum biomarker that can reflect intrahepatic cccDNA is required for evaluation of HBV virological, biochemical activity and therapeutic response. Aim of the study was to assess serum hepatitis B pregenomic RNA in low viremia patients (HBV DNA < 2000 IU/ml) and high viremia (HBV DNA > 2000 IU/ml).

Material and methods: This study was carried out on two groups of chronic hepatitis B patients: group A - 40 patients with low viremia (HBV DNA < 2000 IU/ml); group B - 40 patients with high viremia (HBV DNA > 2000 IU/ml when diagnosed). They were assessed before treatment and after 6 months of treatment (entecavir 0.5 mg/24 h). Serum HBV pregenomic RNA was quantified using RT-PCR.

Results: Pregenomic RNA (pgRNA) was significantly lower in group A than in group B (before treatment). Moreover, it was significantly lower after 6 months of treatment than before treatment in group B. A significant positive correlation was observed between pgRNA and HBV DNA in groups A and B (before treatment); however, after 6 months of treatment of group B patients, although 35 patients had undetectable HBV DNA, they showed detectable levels of serum pgRNA and pgRNA > 4000 IU/ml was associated with virological and biochemical activity.

Conclusions: Serum HBV pregenomic RNA might be a promising marker for assessment of HBV virological, biochemical activity and evaluating therapeutic responses.

Keywords: HBV cccDNA; HBV pregenomic RNA; biomarker; entecavir; noninvasive.