Therapeutic Option for Hepatitis B and C: a French Cohort

Active, not recruiting

• Conditions: Viral Hepatitis B; Viral Hepatitis C

• Registration Number: NCT01953458
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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

Study Timeline

• Study Start: 2012-08-06
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31
• Primary Completion: 2024-12
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20902

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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