Clinical trial NCT04437277: Screening for Chronic Hepatitis C Virus in Hospitalized Patients
Official title: Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of hepatitis C through the different department of Saint Joseph Hospital
timeFrame: one day
Secondary outcomes:
measure: number of viremic patients with risk factors
timeFrame: one day
measure: number of viremic patients without risk factors
timeFrame: one day
measure: number of patients who refuse viral screening
timeFrame: one day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
state: Paca
Study officials:
References: