Therapeutic Option for Hepatitis B and C: a French Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Therapeutic Option for Hepatitis B and C: a French Cohort

Conditions
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Viral Hepatitis B, Viral Hepatitis C

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hepatitis C and/or B<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives. | Effectiveness of HCV or HBV treatments: Virological response, seroconversion, loss of agHbS, liver fibrosis or clinical response (including quality of life), safety. Prognostic factors of HCV or HBV infection: liver fibrosis, cirrhosis, clinical or biological event. Biomarker studies: Virological response, seroconversion, loss of agHbS, liver fibrosis, clinical or biological event, safety Cost-effectiveness studies: cost perYLS, cost per QALY | From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B and C, ANRS HEPATHER French Cohort