Therapeutic Option for Hepatitis B and C: a French Cohort
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
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