Therapeutic options for hepatitis B and C: a French nationwide cohort study FRESH-PEF3286-en Fabrice CARRAT Therapeutic options for hepatitis B and C: a French nationwide cohort study HEPATHER FRESH-PEF3286-en 3286 FRESH-PEF3286 Stanislas POL Fabrice CARRAT AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE) INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) Epidemiology France Portal (PEF) AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE) AGENCE NATIONALE DE LA RECHERCHE (ANR) null Stanislas;POL Fabrice;CARRAT Therapeutics Virology Pathology and Physiopathology Public health antiviral HBV therapies drug resistant mutants Infectious disease medicine Hepatology Healthcare system determinants: Use of care Healthcare system determinants The HEPATHER project aims to set-up a cohort of patients with viral hepatitis B or C in order to improve management and care, givin the changing era of therapeutic options as news drugs come on the market. A major scientific and public-health challenge will be to improve quality of medical care in chronic hepatitis taking into account the different treatment options and host characteristics. The objectives of this cohort will be: - To describe the epidemiology of these chronic infection at a period when screening of viral infection and early diagnosis increase, and genetic and research of biomarkers of disease progression or treatment success are rapidly evolving; -To obtain original data on efficacy and safety of new hepatitis treatments in real-life, on a large size of patients, with a long term follow-up, allowing to estimate the public health impact of these treatments in terms of reduction of morbidity or mortality; - To study the relative effects of treatments to determine, at the level patient, which will be most likely to improve overall health and to limit emergence of variants and breakthrough; - To elaborate and compare cost-effectiveness strategies for the management and treatment of chronic HCV and HBV infections ; - To offer outstanding competency and ressources for the design of clinical trials on specific sub-population This project got an original governance including academic and regulatory institutions as well as pharmaceutical industries and patients associations null France Individuals Patients population Male Female Young Adult (19 to 24 years) Adult (25 to 44 years) Middle Aged (45 to 64 years) Aged (65 to 79 years) Aged, 80 and over (80 years and more) HBV-positive patients - chronic hepatitis B defined by a positive HBs Ag for at least 6 months, with less than 50% of inactive carriers - acute hepatitis B defined as a recent appearance (<6 months) of detectable HBs Ag, with or without association with acute or chonic 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 B defined by the recent appearance of HCV RNA (<6 months) in patients with risk factors (with or without positives antibodies) - patients with cured hepatitis C defined by lond term radication, either treatment, either spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collection - 6 months interval time (this patients should represent less than 10% patients). Clinical data Participant-reported health data Biological data Socio-demographic data Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Other Through organizations (health services or institutions schools businesses etc.) >= 20000 individuals Interview with the participant (including clinical) Observational Study Observational Study Cohort study - 15,000 patients / hépatite C c- 10,000 patients / hépatite B c Unknown Restricted access The executive committee will establish policies to facilitate data sharing and to provide a mechanism for tracking publications related to and resulting from Hepather data. Moreover the executive committee will monitor contributions of the ancillary studies to the community and will require results to be incorporated into a resource database for use by other researchers. Accessibility of the database will be determined case by case by the executive committee in agreement with the scientific committee. The intellectual property and contractual issues will be managed by Inserm Transfert. Special attention will be paid on confidentiality, ethical issues and on the use of the biobank to yield the greatest scientific value to the community and avoid depletion of this finite ressource. The proposal will be examined by the executive committee. The committee will assist academic and private researchers with queries and will advise on data quality, study design and data analysis if necessary. The committee will ensure the coherence with other projects. The executive committee will evaluate methodological aspects and scientific relevance based on reports from the scientific committee. Independent external experts will provide advice on decisions relative to access rights, for example on issues related to the access on one industrial to data linked to the product of another industrial. It will prioritize projects. In preparation for data sharing, much attention will be paid to the wording within subject consent documents. The flexibility of web-based database will also facilitate the addition of new questionnaires for ancillary studies. Access on specific project only