Hepatitis B Infection Surveillance

Official title

National Surveillance of Patients With Chronic Hepatitis B (±D) From Expert/Reference Hepatology Centers (FPRH), Hepatology Departments in General Hospitals (ANGH), and the Virology and Medical Pharmacology Network (ANRS-MIE)

Overview

France is a low-endemicity country for hepatitis B virus (HBV) infection. In 2016, the prevalence of chronic HBV infection in the general population was estimated at 0.3%, corresponding to more than 135,000 HBsAg-positive individuals, of whom 82% were unaware of their infection. Data on hepatitis D virus (HDV) infection remain limited; however, available studies suggest a prevalence of 6% to 10% among HBsAg-positive individuals. Despite current guideline recommendations, up to 35% of newly diagnosed HBsAg-positive patients between 2018 and 2022 were not screened for HDV infection. The World Health Organization (WHO) targets for 2030 include a 90% reduction in the incidence of chronic viral hepatitis, a 65% reduction in hepatitis-related mortality, and treatment coverage for 80% of eligible diagnosed individuals. Achieving these goals will require strengthening HBV and HDV screening strategies and improving linkage to care and retention throughout the care cascade. Objectives: The primary objective is to assess the severity of liver disease, including significant fibrosis (≥F2) and cirrhosis (F4), among adults newly diagnosed with chronic HBV infection (with or without HDV infection) at Expert/Reference Hepatology Centers and Hepatology or Infectious Diseases Departments. The secondary objectives are to: 1. Describe demographic and virological characteristics of HBsAg-positive patients; 2. Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months; 3. Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection; 4. Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis; 5. Compare clinical and virological characteristics of HBV-monoinfected and HBV/HDV-coinfected patients; 6. Identify molecular signatures associated with liver disease severity; 7. Compare findings with those of a national cohort conducted 15 years earlier; 8. Collect biological samples for future analyses; 9. Assess the clinical utility of a highly sensitive HBcrAg assay. Method: This is a multicenter, observational study including all adults aged ≥18 years with chronic HBV infection, whether managed as outpatients or inpatients, who are newly referred to Expert/Reference Hepatology Centers or to Hepatology or Infectious Diseases Departments. Conclusions: This study will generate updated national data on liver disease severity, treatment eligibility, and virological characteristics among adults newly diagnosed with chronic HBV infection in France.

Primary outcome measures

• Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4) [Time frame: Baseline (at inclusion)]

Secondary outcome measures (10)

• Demographic characteristics of newly identified chronic HBsAg carriers [Time frame: Baseline (at inclusion)]
• Virological characteristics of newly identified chronic HBsAg carriers [Time frame: Baseline (at inclusion)]
• Antiviral treatment eligibility and response [Time frame: Baseline (at inclusion), 6 months and 12 months]
• Performance of novel virological markers (HBcrAg level and HBV RNA level) in identifying patients at risk of disease progression [Time frame: Baseline (at inclusion)]
• Diagnostic performance of HBsAg thresholds, in combination with other virological markers for distinguishing HBeAg-negative chronic HBV infection from HBeAg-negative chronic hepatitis B [Time frame: Baseline (at inclusion)]
• Characteristics of HDV infection [Time frame: Baseline (at inclusion)]
• Genome sequence analysis and identification of HBV motifs associated with the severity of liver disease in HBV/HDV-coinfected patients [Time frame: Baseline (at inclusion)]
• Comparison with previous French cohort data (2008-2012) [Time frame: Baseline (at inclusion)]
• Biobank collection [Time frame: Baseline (at inclusion)]
• Clinical performance of ultra-sensitive HBcrAg assay (iTACT-HBcrAg) [Time frame: Baseline (at inclusion)]

Eligibility criteria

Inclusion criteria

• Age 18 years or older
• Chronic HBsAg carriage
• First referral to participating expert/reference hepatology centers or hepatology/infectious diseases departments
• Written informed consent obtained
• Affiliation with national health insurance system or equivalent coverage

Exclusion criteria

• Telephone-only referrals or medical record-only consultations
• Telemedicine-only consultations
• Inability or unwillingness to comply with study procedures
• Inability to understand study objectives or procedures
• Individuals deprived of liberty, under guardianship or under conservatorship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Stéphane Chevaliez — Créteil

Identifiers

NCT: NCT07727187 · APHP 251807

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗