New HBV Infection Biomarkers: Clinical Characterization and Impact on Management

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.

Inclusion criteria

• 18 years old
• Chronic HBV infection (HbsAg positive carrier for more than 6 months)
• Patient under care within the Henri Mondor-Albert Chenevier University Hospital group

Exclusion criteria

• History of liver transplantation for liver failure in the context of chronic HBV infection
• Protected adults, adults unable to express their consent
• Pregnant or breastfeeding women
• Person not affiliated with a Social Security system
• Patient refusal to participate in the project