Screening for Chronic Hepatitis C Virus in Hospitalized Patients (DeViCHO)

Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille

Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the HAS, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who have been or have been imprisoned. Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in Saint Joseph. These previously identified patients with comorbidities will be cared for according to current national practices that reduce HCV morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Diagnostic test: Hepatitis C, serology

Detailed Description

Hepatitis C screening is based on a blood test, in particular the Elisa test, which looks for anti-HCV antibodies. In the case of positive C viral serology, the search for the C virus from a blood test makes it possible to detect the genome (RNA) of the virus, which is thus directly detected by a so-called "PCR" technique. Although screening activity is important in France, it remains insufficient. In December 2016, HAS concluded that risk-based targeted screening has limitations and contributes to the persistence of a hidden epidemic of viral C infection. It is estimated that 75,000 people are unaware of being carriers of the hepatitis C virus. However, there is safe, effective and well-tolerated treatment. With duration of 8 to 12 weeks it allows a healing of HCV in more than 95% of subjects. AFEF recommendations aim to achieve viral elimination C (as early as 2025). This elimination is defined as a 90% decrease in new infections associated with a 65% reduction in HCV mortality. OMS has planned this target for 2030. To achieve this goal, a number of measures are gradually being implemented focusing on universal treatment and universal screening. The hospital may be a place where systematic screening is interesting. In 2017, the prevalence of anti-HCV positive antibodies in the facility, apart from the Hepato-Gastroenterology service, was 1.7%, more than twice the estimated prevalence in our general population. These data give a rationale for the realization of this study.

• Study Type: Interventional
• Enrollment (Actual): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13008
      • Hôpital Saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all in-patient patients and consenting to participate at the study.

Exclusion Criteria:

• Refusal to participate in the study
• Contraindication to a blood sample (Impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample)
• Minor patient
• Patient unable to express consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients consenting

Diagnostic test: Hepatitis C, serology; Inclusion of patients in conventional hospitalization at Saint Joseph Hospital. Each consenting patient benefits from a screening HCV serology carried out during a biological sample indicated by his state of health. In the case of positive HCV serology, an additional sample will be taken in search of viral replication. All detectable HCV PCR patients will be admitted to hepatology consultation for assessment of liver status including non-invasive methods and possible treatment according to the conditions of the Marketing Authorization and recommendations for routine clinical practice. Data on management (treatment or non-treatment and treatment outcome: prolonged virological response 12 weeks after completion of treatment) will be collected.; Other Names: Hepatitis C, PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of hepatitis C through the different department of Saint Joseph Hospital	At every hospitalized patients the trial will be presented. the viral screening will be proposed for the purpose of treating patients who will be viremic	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of viremic patients with risk factors	Identify viremic patients enrolled with identified risk factors	one day
number of viremic patients without risk factors	Identify viremic patients enrolled without identified risk factors	one day
number of patients who refuse viral screening	study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate	one day

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2019
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: 2018-A02595-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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