Differentially expressed circulating miRNAs during interferon therapy for 48 weeks to reduce HBsAg levels in HBeAg negative chronic hepatitis B patients. Homo sapiens

In the current single-armed prospective study, HBeAg negative chronic hepatitis B patients with compensated liver function undertook weekly PEG-IFN subcutaneous injection for 48 weeks. Furthermore, serum miRNAs, extracted from sera taken at 24th week, were analyzed to identify predictive biomarkers for HBsAg reduction. Overall design: Patients: Consecutive adult patients with HBeAg-negative chronic hepatitis B patients were enrolled in the current study. Additional including criteria were serum HBV-DNA < 4-5 log copies/ml and alanine aminotransferase (ALT) < 100 U/l. Patients who have already been prescribed nucleos(t)ides analogues were also included in the current study. Exclusion criteria were evident cirrhosis, psychiatric diseases, absolute neutrophil count < 1.0×109/l, platelet (Plt) < 50×109/l and a history of alcohol or drug abuse. Written informed consent was obtained from each patient. The study was conducted in accordance with the ethical principal of the Declaration of Helsinki and approved by the ethical committee of Kagawa University, Faculty of Medicine. Study design: The patients were assigned to the single arm in which 180 μg or 90 μg dose of pegylated interferon α-2a (PEG-IFN) was injected subcutaneously once a week for 48 weeks. All patients were followed up until the 96th week. Sera taken at 24 week were subject to miRNA analyses to identify predicting miRNAs for HBsAg drop at 48 week and 96 week. Efficacy of treatment: The primary end point was defined as 1 log drop of HBsAg levels comparing to those before the treatment initiation. The secondary end point was defined as declines of serum HBV-DNA levels below 2.1 log copies/ml. The efficacy of 48weeks-treatment was evaluated at 48th and 96th week.