Genotype and Subtype Mapping of the Hepatitis C Virus

NCT07503288 | Not Yet Recruiting DMC

• 1 other identifier: APHP251362
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic hepatitis C virus (HCV) infection is the second leading cause of primary liver cancer worldwide and the leading cause in the United States. In 2020, an estimate 260,000 deaths were attributable to HCV globally, nearly 80,000 of which occurred in Europe, mainly due to complications such as cirrhosis or hepatocellular carcinoma (HCC). The CARTO-VHC study is a retrospective, observational, multicenter study based on data and samples collected during routine care from 2023 to 2024. The study does not involve direct human participation. The study aims to describe the different genotypes and subtypes of the hepatitis C virus, including unusual subtypes, in a large population of newly diagnosed HCV-positive patients. This will help identify the most common types circulating in France. Additionally, the study will provide a comprehensive understanding of therapeutic failures and drug resistance to direct-acting antivirals (DAA) in treated patients.

Conditions

Hepatitis C Virus; Mutation Abnormality; RNA Positive; Unusual Subtype; Resistance

Outcome Measures

Primary Outcomes (1)

• Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations.

  1st year

Secondary Outcomes (6)

• Proportion of patients with cirrhosis

  last 6 month of 1st year

• Proportion of patients infected with an "unusuel" subtype

  1st 6 month of 3rd year

• Proportion of viruses carrying polymorphisms in the NS3, NS5A, and/or NS5B genes among the "unusuel" subtypes

  Last 6 month of 2nd year and first 6 month of 3rd year

• Proportion of patients with treatment failure

  Trim 2 and trim 3 of 3rd year

• Proportion of RAS (resistance-associated substitutions) in the regions targeted by DAAs among patients with treatment failure, according to the HCV genotype

  Last 6 month of 3rd year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Defined population

You may qualify if:

• Patient aged 18 years old or more
• Newly diagnosed patient positive for HCV (presence of HCV antibodies)
• Patient with active infection (HCV RNA \> 0)

You may not qualify if:

• Patients who decline to participate in the study and oppose the use of their personal data
• Patients under legal protection (guardianship or curatorship)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP Henri Mondor

Créteil, 94000, France

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Stéphane CHEVALIEZ

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Stéphane CHEVALIEZ

CONTACT

+33 1 49 81 28 28; stephane.chevaliez@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

FR (1)