This study focuses on the chronic Hepatitis B virus (HBV) infection, which affects nearly
300 million people globally, leading to cirrhosis, hepatocellular carcinoma (HCC), and
other severe liver diseases. The objective is to evaluate new biomarkers for HBV
infection, specifically HBV core-related antigen (HBcrAg) and HBV RNA, and their
potential role in the clinical management and prognosis of the disease. Traditional
biomarkers used to track viral replication and liver fibrosis, such as HBV DNA, HBeAg,
and HBsAg, have limitations, which this study aims to address by exploring emerging
biomarkers that could improve the understanding of the infection's natural history and
response to antiviral treatments.
The population involved in the study includes patients diagnosed with chronic HBV
infection and receiving care at Henri Mondor-Albert Chenevier University Hospital.
Patients must be 18 years or older and have been infected with HBV (positive HBsAg for
more than six months). Exclusion criteria include individuals with liver transplantation
history, those unable to provide consent, pregnant or breastfeeding women, and those not
affiliated with a Social Security scheme.
The study design includes both primary and secondary evaluation criteria. The primary
criterion is the incidence of HBsAg seroconversion (absence of detectable HBsAg in
serum). Secondary criteria include the proportion of patients positive for HBeAg, the
incidence of clinical events like cirrhosis and HCC, and the molecular characterization
of HBV, such as genotype distribution and the presence of co-infections like hepatitis C
(HCV) or HIV. Other secondary criteria also include the measurement of liver fibrosis
using Fibroscan and screening for HCC through abdominal ultrasound and alpha-fetoprotein
(AFP) tests.
Research procedures involve routine medical consultations, with additional blood samples
(9mL dry tube and 9mL Paxgene) collected for research purposes once a year. Patients will
be followed for a period of 10 years, with regular monitoring of HBV biomarkers and liver
status to evaluate the progression of the infection, the risk of developing liver
disease, and the potential predictive value of new biomarkers for viral replication and
clinical outcomes. The ultimate aim is to enhance HBV management by identifying
predictive biomarkers and refining treatment strategies, particularly to optimize
antiviral therapies and improve patient prognosis.