Genotype and Subtype Mapping of the Hepatitis C Virus (CARTO-VHC)

Cartographie Des génotypes et Sous-types du Virus de l'hépatite C

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis C Virus; Mutation Abnormality; Resistance; RNA Positive; Unusual Subtype

Detailed Description

The study will consist of the following:

1. Inclusion of patients who meet the selection criteria (hospitalized patients and outpatients from tertiary centers in mainland France) ;
2. Collecting all associated data, including demographic, clinical, and therapeutic information. A Clinical research technician may be assigned to centers lacking sufficient human resources;
3. Collect leftover patient specimens for viral genotyping (phylogenetic analysis of a portion of the NS5B gene, the reference method) or complete genome sequencing of unusual subtypes;
4. Perform molecular biology genotyping techniques (RNA extraction, PCR, and Sanger sequencing of a portion of the NS5B gene);
5. Carry out next-generation sequencing (Seq2000, Illumina) of the full genome of "unusual" subtype strains, or DAAs resistant patients
6. Analyze genotype and subtype information, as well as its correlation with demographic, clinical, and therapeutic data.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Stéphane CHEVALIEZ; Phone Number: +33 1 49 81 28 28; Email: stephane.chevaliez@aphp.fr

Study Locations

• France
  • Créteil, France, 94000
    • AP-HP Henri Mondor
    • Contact: Laetitia GREGOIRE; Phone Number: +33 1 49 81 41 64; Email: laetitia.gregoire@aphp.fr
    • Contact: Sara MASMOUDI; Phone Number: +33 1 49 81 44 86; Email: sara.masmoudi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Defined population

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations.	1st year

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Proportion of patients born in Asia and Africa	2nd year and 1st trimester of 3rd year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Stéphane CHEVALIEZ, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C
• Other Study ID Numbers: APHP251362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No