Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With HIV and HCV

Completed

• Conditions: HIV; Hepatitis C

• Registration Number: NCT03324633
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

The ANRS CO13 HEPAVIH cohort is a prospective and multicentric cohort created in 2005 with the originality to cover two therapeutic domains of key importance, AIDS and hepatitis C. The cohort, is unique in Europe with more than 1800 participants followed over 10 years including quality of life and compliance to treatment data.

Detailed Description

The cohort has been created in 2005 with the general objective to better define the natural history of HCV/HIV co-infection in terms of morbidity and mortality. Furthermore, the cohort aims to determine factors associated with morbidity and mortality and to better understand interactions between the two viruses and their respective treatments.

The ANRS CO13 Hepavih is currently composed of 28 french metropolitan clinical centers of infectious diseases and hepatogy diseases (mostly teaching hospital).

The period of patient inclusion has been divided in three distinct phases: the first phase (Phase 1) that started in 2005 and ended in 2008, was dedicated to the inclusion of adult HCV/HIV co-infected patients. The following inclusion phase (Phase 2) that concerns patients who received a triple-agent anti-HCV therapy including Boceprevir or Telaprevir, started in 2008 and ended in march 2016. The third one (Phase 3) focusing on patients initiating a DAA anti HCV treatment started in June 2014 and ended in November 2015. Regarding Phase 3, the specific objectives were organized into five thematic domains including clinic, virology, pharmacology, public health and methodology.

Since 31 march 2016, the inclusions are closed and 1,850 patients have been included. The ended of the follow-up is planned on the 31 december 2018.

At the inclusion and during the follow-up period (at least once a year or every 6 months in case of cirrhosis, until 2018 and probably also beyond that date), each HCV/HIV co-infected patient is offered a clinical examination as well as an interview. Additional self-questionnaires are filled by the included patients at the same time points (Social sciences data). The types of data collected from each co-infected patient included in the cohort are organized according to five major thematic classes: socio-demography and behavior, HIV characteristics, HCV characteristics, clinical relevant events, anthropometry, paraclinic data.

The ANRS CO13 HEPAVIH cohort has the purpose to become a facility for specific research regarding the physiopathological and therapeutic aspects of the HCV/HIV co-infection at the disposal of the entire scientific community.

In july 2016, the cohort has pusblished 29 originals articles and 10 as a part of national and European collaborations.

The ANRS CO13 HEPAVIH cohort has adopted functional governance. The Steering Committee, made-up of clinicians, methodologist, the sponsor as well as the cohort coordinators, is focused on logistic and operational aspects of the cohort. The Scientific Committee is the scientific decision-making organization, made-up with scientist experts in main research fields including methodology, hepathology, infectiology, pharmacology, virology and social science, and representatives of the ANRS and patient organizations. It assesses requests for the access to the cohort and provides advices on scientific, methodological and ethical aspects in order to ensure an effective scientific conduct of the research. The Steering Comitee meet once a month and the Scientific Comitee 2/3 times a year.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2017-03-21
• Primary Completion: 2017-09
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-30
• Study Completion: 2022-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1850

Inclusion Criteria

All phases of inclusion:

• Patients aged ≥18 years,
• Cover by a social security,
• Able to understand the consent conform.

Phase 1:

• HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment)

Phase 2:

• HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with protease inhibitor based treatment (PegIFN, Ribavirin and Telaprevir or Boceprevir) or having cleared HCV spontaneously in the absence of anti-HCV treatment

Phase 3:

• HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with DAA anti-HCV treatment (all combinations)

Exclusion Criteria

• Patients <18 years old
• So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
• Without an healthcare insurance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improve effectiveness and quality of medical care in Hepatitis C in HIV patients	Through study completion : One visit/year for each participant + one additionnal visit every 6 months for patients with a cirhhosis	The CRFs compile clinical, biological, genetic and virological data : Clinical events, treatments (HIV, HVC, others), clinical exams (height, weight, hip and waist circumferences), virological : CD4, CD8, HIV RNA, HVC RNA (+genotype), HVB serology, liver functions tests and biology (fibroscan, fibrotest, ultrasound, transaminases, bilirubin, alkaline phosphatase, gamma GT,...), metabolic biochemistry (glycemia, insulin, cholesterol, creatinin, lipase). Patients also completed sociales sciences questionnaires (quality of life, depression,...) During the annual visit, samples are taken : blood for DNA, serum and plasma and are stocked in a biobank used for scientific projects.