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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,360
- 试验地点
- 1
- 主要终点
- Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4)
研究概览
简要总结
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:
- Describe demographic and virological characteristics of HBsAg-positive patients;
- Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months;
- Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection;
- Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis;
- Compare clinical and virological characteristics of HBV-monoinfected and HBV/HDV-coinfected patients;
- Identify molecular signatures associated with liver disease severity;
- Compare findings with those of a national cohort conducted 15 years earlier;
- Collect biological samples for future analyses;
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4)
时间窗: Baseline (at inclusion)
Liver disease severity assessed by non-invasive methods (liver stiffness measurement, direct or indirect serum biomarkers, composite scores such as FIB-4) and/or liver biopsy. Significant fibrosis is defined as METAVIR score F2 or higher
次要结局
- Demographic characteristics of newly identified chronic HBsAg carriers(Baseline (at inclusion))
- Virological characteristics of newly identified chronic HBsAg carriers(Baseline (at inclusion))
- Antiviral treatment eligibility and response(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(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(Baseline (at inclusion))
- Characteristics of HDV infection(Baseline (at inclusion))
- Genome sequence analysis and identification of HBV motifs associated with the severity of liver disease in HBV/HDV-coinfected patients(Baseline (at inclusion))
- Comparison with previous French cohort data (2008-2012)(Baseline (at inclusion))
- Biobank collection(Baseline (at inclusion))
- Clinical performance of ultra-sensitive HBcrAg assay (iTACT-HBcrAg)(Baseline (at inclusion))