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Viral Hepatitis BHEPATHERNCT01953458

Therapeutic Option for Hepatitis B and C: a French Cohort

An observational study of Viral Hepatitis B and Viral Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Viral Hepatitis B, Viral Hepatitis C
How many people
20,902 participants
Where
1 siteFrance
Study dates
6 Aug 2012to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HBV-positive patients and/or HCV-positive patients

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Study site

    Multiple Locations

Other trials in France

About this study

  • 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.
Read the 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
Keywords
Hepatitis B and C, ANRS HEPATHER French Cohort
Medical subject headings
Hepatitis B, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01953458
Study groupRoleWhat they receive
hepatitis C and/or BNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study start6 Aug 2012
  3. Primary completionDec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01953458
Sponsor's protocol ID
ANRS CO22 HEPATHER
Other IDs
2011-A01438-33
Acronym
HEPATHER
Status last verified
Jan 2023
First submitted
19 Sep 2013
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Lotto M, Ramier C, Carrat F, Perieres L, Delaroque-Astagneau E, Nicol J, Marcellin F, Zoulim F, Di Beo V, Bertheau M, Pol S, Protopopescu C, Bourliere M, Carrieri P; ANRS/AFEF CO22 HEPATHER Study Group. Mortality risk in migrant and non-migrant individuals with chronic hepatitis B virus infection: a French hospital-based cohort study (ANRS CO22 HEPATHER). BMC Glob Public Health. 2025 Jul 1;3(1):58. doi: 10.1186/s44263-025-00173-7.

    PubMed 40598581

  • Barre T, Parlati L, Bourliere M, Ramier C, Marcellin F, Protopopescu C, Di Beo V, Moins C, Dorival C, Nicol J, Zucman-Rossi J, Mathurin P, Larrey D, Boursier J, Carrat F, Carrieri P; ANRS/AFEF Hepather Study group. Socioeconomic Deprivation Weighs Heavily on Liver Fibrosis and Mortality After Hepatitis C Cure (ANRS CO22 Hepather). J Viral Hepat. 2024 Dec;31(12):830-846. doi: 10.1111/jvh.14006. Epub 2024 Sep 10.

    PubMed 39252600

  • Poynard T, Lacombe JM, Deckmyn O, Peta V, Akhavan S, Zoulim F, de Ledinghen V, Samuel D, Mathurin P, Ratziu V, Thabut D, Housset C, Fontaine H, Pol S, Carrat F. External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B. Gastro Hep Adv. 2022 May 25;1(4):604-617. doi: 10.1016/j.gastha.2022.02.008. eCollection 2022.

    PubMed 39132068

  • Barre T, Bourliere M, Parlati L, Ramier C, Marcellin F, Protopopescu C, Di Beo V, Cagnot C, Dorival C, Nicol J, Zoulim F, Carrat F, Carrieri P; ANRS/AFEF Hepather Study group. 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? (ANRS CO22 Hepather cohort). Drug Alcohol Rev. 2024 Mar;43(3):718-731. doi: 10.1111/dar.13802. Epub 2023 Dec 22.

    PubMed 38133601

  • Carrieri P, Bourliere 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. Impaired health-related quality of life in the HCV cure era: who is concerned? (ANRS CO22 HEPATHER French cohort). Qual Life Res. 2023 Dec;32(12):3427-3438. doi: 10.1007/s11136-023-03496-w. Epub 2023 Aug 16.

    PubMed 37587323

  • 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. Diversity of the nucleic acid forms of circulating HBV in chronically infected patients and its impact on viral cycle. Hepatol Int. 2022 Dec;16(6):1259-1272. doi: 10.1007/s12072-022-10389-6. Epub 2022 Aug 4.

    PubMed 35927368

  • Barre T, Carrat F, Ramier C, Fontaine H, Di Beo V, Bureau M, Dorival C, Larrey D, Delarocque-Astagneau E, Mathurin P, Marcellin F, Petrov-Sanchez V, Cagnot C, Carrieri P, Pol S, Protopopescu C; ANRS/AFEF Hepather study group. Cannabis use as a factor of lower corpulence in hepatitis C-infected patients: results from the ANRS CO22 Hepather cohort. J Cannabis Res. 2022 Jun 11;4(1):31. doi: 10.1186/s42238-022-00138-9.

    PubMed 35690798

  • Pageaux GP, Nzinga CL, Ganne N, Samuel D, Dorival C, Zoulim F, Cagnot C, Decaens T, Thabut D, Asselah T, Mathurin P, Habersetzer F, Bronowicki JP, Guyader D, Rosa I, Leroy V, Chazouilleres O, de Ledinghen V, Bourliere M, Causse X, Cales P, Metivier S, Loustaud-Ratti V, Riachi G, Alric L, Gelu-Simeon M, Minello A, Gournay J, Geist C, Tran A, Abergel A, Portal I, d'Alteroche L, Raffi F, Fontaine H, Carrat F, Pol S; French ANRS CO22 Hepather Cohort. Clinical outcomes after treatment with direct antiviral agents: beyond the virological response in patients with previous HCV-related decompensated cirrhosis. BMC Infect Dis. 2022 Jan 27;22(1):94. doi: 10.1186/s12879-022-07076-0.

    PubMed 35086481

  • Poynard T, Lacombe JM, Deckmyn O, Peta V, Akhavan S, de Ledinghen V, Zoulim F, Samuel D, Mathurin P, Ratziu V, Thabut D, Housset C, Fontaine H, Pol S, Carrat F. External validation of LCR1-LCR2, a multivariable HCC risk calculator, in patients with chronic HCV. JHEP Rep. 2021 Apr 24;3(4):100298. doi: 10.1016/j.jhepr.2021.100298. eCollection 2021 Aug.

    PubMed 34142073

  • Barre T, Ramier C, Di Beo V, Carrat F, Fontaine H, Marcellin F, Carrieri P, Pol S, Protopopescu C; ANRS/AFEF Hepather study group. Liver fibrosis and all-cause mortality in chronic HCV-infected diabetic patients: A paradoxical association? (ANRS CO22 HEPATHER). Liver Int. 2021 Jul;41(7):1694-1698. doi: 10.1111/liv.14949. Epub 2021 May 28. No abstract available.

    PubMed 33993651

  • Chalouni M, Pol S, Sogni P, Fontaine H, Lacombe K, Marc-Lacombe J, Esterle L, Dorival C, Bourliere M, Bani-Sadr F, de Ledinghen V, Zucman D, Larrey D, Salmon D, Carrat F, Wittkop L; ANRS CO13 HEPAVIH and ANRS CO22 HEPATHER cohort study groups. Increased mortality in HIV/HCV-coinfected compared to HCV-monoinfected patients in the DAA era due to non-liver-related death. J Hepatol. 2021 Jan;74(1):37-47. doi: 10.1016/j.jhep.2020.08.008. Epub 2020 Aug 14.

    PubMed 32798585

  • 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. Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort. BMC Infect Dis. 2019 Apr 2;19(1):300. doi: 10.1186/s12879-019-3923-5.

    PubMed 30940090

  • 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. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet. 2019 Apr 6;393(10179):1453-1464. doi: 10.1016/S0140-6736(18)32111-1. Epub 2019 Feb 11.

    PubMed 30765123

  • 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. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. J Hepatol. 2017 Jan;66(1):39-47. doi: 10.1016/j.jhep.2016.08.021. Epub 2016 Sep 10.

    PubMed 27622858

Questions about this trial

What is this clinical trial studying?

An observational study of Viral Hepatitis B and Viral Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives. (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01953458, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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