Therapeutic Option for Hepatitis B and C: a French Cohort

N/AUnknownNCT01953458

ANRS, Emerging Infectious Diseases20,902 enrolled

Overview

* 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

Study Type

OBSERVATIONAL

Enrollment

20,902

Conditions

Viral Hepatitis B Viral Hepatitis C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, France

Outcomes

Primary Outcomes

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

Time frame: 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)

Data from ClinicalTrials.gov

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