Therapeutic Option for Hepatitis B and C: a French Cohort

Conditions

Viral Hepatitis B, Viral Hepatitis C

Keywords

Hepatitis B and C, ANRS HEPATHER French Cohort

Brief summary

* 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

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

Lotto M, Ramier C, Carrat F, Périères L, Delaroque-Astagneau E, Nicol J, Marcellin F, Zoulim F, Di Beo V, Bertheau M, Pol S, Protopopescu C, Bourlière M, Carrieri P, ANRS/AFEF CO22 HEPATHER Study Group.

2025-07-01

10.1186/s44263-025-00173-7

Socioeconomic Deprivation Weighs Heavily on Liver Fibrosis and Mortality After Hepatitis C Cure (ANRS CO22 Hepather)

Tangui Barré, Lucia Parlati, Marc Bourlière, Clémence Ramier, Fabienne Marcellin et al. (17 authors)

Journal of Viral Hepatitis2024-09-101 citations

10.1111/jvh.14006

Hepatitis C virus cure from direct‐acting antivirals and mortality: Are people with and without a history of injection drug use in the same boat? (<scp>ANRS CO22</scp> Hepather cohort)

Tangui Barré, Marc Bourlière, Lucia Parlati, Clémence Ramier, Fabienne Marcellin et al. (14 authors)

Drug and Alcohol Review2023-12-221 citations

10.1111/dar.13802

Impaired health-related quality of life in the HCV cure era: who is concerned? (ANRS CO22 HEPATHER French cohort).

Carrieri P, Bourlière M, Di Beo V, Lusivika-Nzinga C, Ramier C, Antwerpes S, Protopopescu C, Lacombe JM, Pol S, Fontaine H, Mourad A, Carrat F, Duracinsky M, Marcellin F, ANRS/AFEF HEPATHER Study Group.

2023-08-162 citations

10.1007/s11136-023-03496-w

Diversity of the nucleic acid forms of circulating HBV in chronically infected patients and its impact on viral cycle.

Sotty J, Bablon P, Lekbaby B, Augustin J, Girier-Dufournier M, Langlois L, Dorival C, Carrat F, Pol S, Fontaine H, Sarica N, Neuveut C, Housset C, Kremdsorf D, Schnuriger A, Soussan P.

2022-08-041 citations

10.1007/s12072-022-10389-6

Cannabis use as a factor of lower corpulence in hepatitis C-infected patients: results from the ANRS CO22 Hepather cohort

Tangui Barré, Fabrice Carrat, Clémence Ramier, Hélène Fontaine, Vincent Di Beo et al. (100 authors)

Journal of Cannabis Research2022-06-111 citations

10.1186/s42238-022-00138-9

Clinical outcomes after treatment with direct antiviral agents: beyond the virological response in patients with previous HCV-related decompensated cirrhosis

Georges‐Philippe Pageaux, Clovis Lusivika‐Nzinga, Nathalie Ganne‐Carrié, Didier Samuel, Céline Dorival et al. (100 authors)

BMC Infectious Diseases2022-01-2712 citations

10.1186/s12879-022-07076-0

External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B

Thierry Poynard, Jean Marc Lacombe, Olivier Deckmyn, Valentina Peta, Sepideh Akhavan et al. (15 authors)

Gastro Hep Advances2022-01-012 citations

10.1016/j.gastha.2022.02.008

External validation of LCR1-LCR2, a multivariable HCC risk calculator, in patients with chronic HCV.

Poynard T, Lacombe JM, Deckmyn O, Peta V, Akhavan S, de Ledinghen V, Zoulim F, Samuel D, Mathurin P, Ratziu V, Ratziu V, Thabut D, Housset C, Fontaine H, Pol S, Carrat F.

2021-04-247 citations

10.1016/j.jhepr.2021.100298

Sofosbuvir‐Daclatasvir is suboptimal in patients with genotype 2 chronic hepatitis C infection: real‐life experience from the HEPATHER ANRS CO22 cohort

Victor de Lédinghen, Clovis Lusivika‐Nzinga, Jean–Pierre Bronowicki, Fabien Zoulim, Dominique Larrey et al. (17 authors)

Journal of Viral Hepatitis2020-05-217 citations

10.1111/jvh.13321

Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort.

Laurain A, Metivier S, Haour G, Larrey D, Dorival C, Hezode C, Zoulim F, Marcellin P, Bourliere M, Zarski JP, Thabut D, Alric L, Ganne-Carrie N, Cales P, Bronowicki JP, Riachi G, Geist C, Causse X, Abergel A, Chazouilleres O, Mathurin P, Guyader D, Samuel D, Tran A, Loustaud-Ratti V, Petrov-Sanchez V, Diallo A, Luzivika-Nzinga C, Fontaine H, Carrat F, Pol S, ANRS/AFEF HEPATHER study group.

2019-04-022 citations

10.1186/s12879-019-3923-5

Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study.

Carrat F, Fontaine H, Dorival C, Simony M, Diallo A, Hezode C, De Ledinghen V, Larrey D, Haour G, Bronowicki JP, Zoulim F, Asselah T, Marcellin P, Thabut D, Leroy V, Tran A, Habersetzer F, Samuel D, Guyader D, Chazouilleres O, Mathurin P, Metivier S, Alric L, Riachi G, Gournay J, Abergel A, Cales P, Ganne N, Loustaud-Ratti V, D'Alteroche L, Causse X, Geist C, Minello A, Rosa I, Gelu-Simeon M, Portal I, Raffi F, Bourliere M, Pol S, French ANRS CO22 Hepather cohort.

2019-02-11420 citations

10.1016/s0140-6736(18)32111-1

Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients.

Pol S, Bourliere M, Lucier S, Hezode C, Dorival C, Larrey D, Bronowicki JP, Ledinghen VD, Zoulim F, Tran A, Metivier S, Zarski JP, Samuel D, Guyader D, Marcellin P, Minello A, Alric L, Thabut D, Chazouilleres O, Riachi G, Bourcier V, Mathurin P, Loustaud-Ratti V, D'Alteroche L, Fouchard-Hubert I, Habersetzer F, Causse X, Geist C, Rosa I, Gournay J, Saillard E, Billaud E, Petrov-Sanchez V, Diallo A, Fontaine H, Carrat F, ANRS/AFEF HEPATHER study group.

2016-09-1080 citations

10.1016/j.jhep.2016.08.021

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives.	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)	* 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

Countries

France

Outcome results