Therapeutic Option for Hepatitis B and C: a French Cohort

* 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.

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

Eligibility Criteria:
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