Abstract Background: The key reason for the persistence of the hepatitis B virus (HBV) is intrahepatic covalently closed circular DNA (cccDNA). Therefore, a noninvasive serum biomarker that can indicate intrahepatic cccDNA is necessary for assessing the virological, biochemical, and therapeutic responses to HBV. Objectives: To measure the level of HBV pre-genomic RNA (pgRNA), associate the measured levels of the pgRNA with that of the fibro scan-based liver fibrosis stage, and correlate with the HBV DNA load and liver enzymes. Monitor Hepatitis B,E Antigen status to compare with the level of HBV-pgRNA. Materials and Methods: Upto 89 patients with persistent HBV infection underwent fibro scan-based liver fibrosis staging, F0, F1, F2, F3, and F4. Their liver fibrosis was monitored by a fibroscan device along with relevant data such as fibroscan staging qualitative HBsAg, and liver enzymes were derived from medical records of patients who were recruited according to the specialist decision. Some of these data were provided by direct interviewing with patients including age, sex, duration of taking antiviral therapy, and duration of the disease. In order to characterize HBV RNA in plasma, we measured its concentration, DNA (viral load), and the quantity of HBsAg, HBe Ag status. For the detection of HBV RNA and DNA in plasma, total nucleic acid was isolated from plasma and separated into two tubes: the first one was treated with DNAse 1 to degrade DNA and the remaining RNA was reverse transcribed into cDNA. HBV DNA and HBV RNA were quantified together using a real-time qPCR technique targeting a conserved segment of the core region after being treated with RNAse enzyme. For HBeAg, qualitative ELISA assay technique was used to determine the status of HBeAg. Results: A total of 89 patients with chronic hepatitis B infection (52 males and 37 females) with a range age of 18–80 years who had undergone fibroscan staging 42 (47.2%F0), 20 (22.5%F1), 11 (12.4%F2), 11 (12.4%F3), and 5 (5.6%F4). Regarding HBeAg status, 94.4% were negative and 5.6% were positive. HBeAg was found to be significantly associated with the staging of fibrosis ( P ≤ 0.01); RNA level was intermediate directly correlated and highly significantly associated DNA levels ( R = 0.31, P ≤ 0.01), level of HBeAg was significantly associated with severity of fibrosis. HBeAg was found to be significantly associated with the staging of fibrosis ( P ≤ 0.01). Conclusions: pgRNA is a promising biomarker to predict liver fibrosis as it is a surrogate biomarker for cccDNA.
Al-Hmadani et al. (Thu,) studied this question.