Therapeutic Option for Hepatitis B and C: a French Cohort (HEPATHER)

ANRS, Emerging Infectious Diseases

Status: Active, not recruiting

Conditions: Viral Hepatitis B; Viral Hepatitis C

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01953458

2011-A01438-33 (Other Identifier)

ANRS CO22 HEPATHER

Details and patient eligibility

About

• The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis.
• The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.

Full description

General schedule of the study :

• Prospective multicenter national study
• Duration of inclusions:3 years
• Effective : 25000 patients
• Duration of the follow-up: 7-8 years
• Duration of the cohort: 10 years

Population :

Twenty-five thousands of people will be included and followed in investigator sites, 15000 with an hepatitis C and 10000 with an hepatitis B, according their usual follow-up of their liver disease.

We aim to include up to 50% patients naive of any HCV treatment at inclusion. Also HBV "cured" patients could be included (less than 10%).

Design study:

• During the recruitment visit, demographics, clinical, biological and virological data will be collected. The patient will move through several assessments involving questionnaires, measurements and blood sampling.
• Then the minimum follow-up is one medical visit per year. The follow-up (clinical data and biological collections) will be driven by events or based on protocols that will be developed on the cohort.
• There is no specific treatment in this cohort.

The scientific project is structured into 4 scientific thematic axes :

• Therapeutics:

  • To analyze the long term effects of therapy
  • To study predictors of virological response or fibrosis progression (or regression)and pharmacokinetic/pharmacodynamics either in HCV or HBV treatments

• Virology:

  • To understand the molecular mechanisms of antiviral treatment success and failure
  • To provide treatment recommendation to prevent resistance and achieve sustained or definitive control of infection

• Pathology and physiopathology :

  • To identify new pathophysiological targets responsible for chronic hepatitis severity,prognosis, and evolution.
  • To validate new therapeutic combinations based on pathophysiological researches

• Public Health:

  • To identify psychosocial and behavioral correlates of access to care, progression of liver disease and of the burden of chronic viral hepatitis B and C.
  • To evaluate the cost-effectiveness of HBV and HCV treatments and quality of life

Enrollment: 20,902 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HBV-positive patients

  • Chronic hepatitis B defined by a positive HBsAg ( surface antigen of the hepatitis B virus) for at least 6 months
  • Acute hepatitis B defined as a recent appearance (<6 months) of detectable HBs Ag,
  • Chronic hepatitis B with serological remission HbsAg-negative , HB DNA-negative,
  • With or without association with acute or chronic hepatitis D.

• HCV-positive patients

  • Chronic hepatitis C defined by the positivity for anti-HCV antibodies for at least 6 months and positive HCV-RNA
  • Acute hepatitis C defined by the recent appearance of HCV RNA (less than 6 months) in patients with risk factors (with or without positive antibodies)
  • Patients with cured hepatitis C defined by long-term eradication, either spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collection - 6 months interval time; either treatment defined by negative viremia 3 month after end of treatment.

Exclusion criteria

• HIV co-infected patients are not eligible to the cohort.
• So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
• Treatment ongoing hepatitis C during or stopped since less than 3 months
• Patients end of life
• Woman whose pregnancy is known

Trial design

20,902 participants in 1 patient group

hepatitis C and/or B