Prevalence and Screening of Hepatitis C in Belgium in 2015
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Questionnaire
HCV serology
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatitis C focused on measuring Hepatitis C, HCV, screening
Eligibility Criteria
Inclusion Criteria:
- All patients admitted to the one day clinic for surgery and gastroenterology.
Exclusion Criteria:
- none
Sites / Locations
- St Pierre Hospital
- CHU Brugmann
- Erasme
- UCL St Luc
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HCV screening
Arm Description
All patients admitted to the one day clinic for surgery and gastroenterology.
Outcomes
Primary Outcome Measures
HCV risk factors questionnaire
All patients admitted to the one day clinic for surgery and gastroenterology will be asked, after signing an informed consent, to fill in a questionnaire regarding HCV risk factors (1 page). The collection of the questionnaires and the entering of the data into an electronic database will be done in an anonymous way.
Positive/Negative Hepatitis C serology
In case of a pre-operative blood sampling, an HCV detection test will be done on the serum as part of the routine pre-operative screening. The sample will be analyzed in the Hospital Laboratory according to the current belgian guidelines regarding hepatitis C virus detection. In patients where no pre-operative blood sample is done, an additional consent will be asked to take a blood sample for HCV detection. In case of a positive test result (positive HCV serology), patients will be contacted. Those patients will be proposed to contact their family doctor (GP) or a specialist of their choice in order to realize a classic work up and discuss therapeutic options if necessary.
Secondary Outcome Measures
Full Information
NCT ID
NCT02393365
First Posted
March 9, 2015
Last Updated
April 16, 2019
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02393365
Brief Title
Prevalence and Screening of Hepatitis C in Belgium in 2015
Official Title
Prevalence and Screening of Hepatitis C in Belgium in 2015
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2015 (Actual)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
December 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hepatitis C is caused by the hepatitis C virus (HCV) that causes inflammation of the liver that can lead to diminished liver function or liver failure.
The number of chronically infected persons worldwide is estimated to be about 170 million that is 2.35% of the world population. Most people infected with the hepatitis C virus have no symptoms of the disease until the advanced stages of liver disease have occurred, which may take several years. The long-term impact of HCV infection is highly variable, from minimal changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC).
Advanced liver disease (ALD) can lead to significant clinical and economic consequences, including liver transplantation. HCV can reduce life expectancy and impair quality of life. HCV-related complications as well as the highly debilitating effects on patients represent a significant item of expenditure for the National Health Service. Because of the latency of infection, numerous country-specific population analyses suggest that HCV will cause an increasing number of liver-related deaths despite the dramatic drop in incidence and prevalence. These deaths will be related to prevalent HCV infection especially during and after World War II through indiscreet and widespread treatment with intravenous injection using contaminated syringes, needles and remunerated blood donors. Eradicating HCV infection can prevent the complications of HCV-related liver and extrahepatic diseases, including liver necroinflammation, fibrosis, cirrhosis, HCC, and death.
Newly discovered hepatitis C virus (HCV) therapy with direct acting antiviral agents (DAA) like Simeprevir, sofosbuvir open a new chapter in the treatment of chronic hepatitis C. Those new treatment regimens promise oral dosing, higher SVR, shorter duration of treatment and fewer side effects. In a near future all patients should qualify for future all-oral therapies.
However recent analysis have shown that increasing efficacy of treatment alone will not be able to reduce the HCV disease burden. The largest reduction in HCV-related morbidity and mortality can be obtained when higher efficacy therapies is combined with increased diagnosis and treatment rate. With a treatment rate of 10% it is possible to achieve a > 90% decline in total infections by 2030. This would require a 3-5 fold increase in diagnosis and/or treatment for most countries.
The implementation of screening criteria for hepatitis C virus (HCV) such as targeting birth cohorts has potential effect on reducing the progression of hepatitis C virus (HCV) to advanced liver disease (ALD) and could avoid unnecessary high financial costs and preserve quality of life.
Robust data from public health surveillance, surveys of the general and risk populations are required to make decisions in allocating public health resources to diagnose, assess and treat HCV infection.
In Belgium no recent prevalence studies have been conducted. The most cited anti-HCV prevalence is 0.87% based on a study in the Flemish population published in 1997 but collected in 1994. In a French Belgian population there was an overall seroprevalence of 0.6%. However, the population under study was not representative for the whole French community, because the recruited subjects were significantly younger.
A survey among cirrhotic and hepatocellular patients in the French community revealed that 20% of cirrhosis and 47% of hepatocellular cancer were related to hepatitis C. The diagnosis rate of HCV in Belgium is estimated at 43%, signifying that more than 50% of HCV patients remains undiagnosed.
Several studies have already mentioned that aged population especially those born after Second World War are carriers of hepatitis C virus infection. Early detection of HCV infection and treating before progress to advanced liver disease (ALD) is an excellent opportunity to rationalize resource allocation and to improve patients' quality of life.
Recently birth cohort screening recommendations were developed in the United States. In Belgium, no formal screening strategy exists. However the Belgian association of the study of the liver (BASL) recommends targeted HCV screening for high-risk populations (including individuals with a blood transfusion or major medical event prior to 1 july 1990, intranasal or IDU and dialysis patients) in addition to nontargeted screening among pre-operative patients and pregnant women. A birth cohort analysis based on a model suggests a birth cohort between 1950 and 1975 in Belgium. This population should reflect 70% of the viremic population.
In this study, the investigators want to estimate the prevalence of hepatitis C in Belgium in 2014 and to confirm the proposed targeted birth cohort and other risk factors. These data could provide an efficient source of identifying newly diagnosed patients as part of a national screening strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, HCV, screening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCV screening
Arm Type
Other
Arm Description
All patients admitted to the one day clinic for surgery and gastroenterology.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
All patients admitted to the one day clinic for surgery and gastroenterology will be asked, after signing an informed consent, to fill in a questionnaire about HCV risk factors.
Intervention Type
Procedure
Intervention Name(s)
HCV serology
Intervention Description
In case of a pre-operative blood sample an HCV serology will also be done as part of a routine pre-operative screening.
In patients where no pre-operative blood sample is done an additional consent will be asked to perform a blood sample for HCV serology. This qualifies the study as 'interventional' according to the Belgian legislation.
Primary Outcome Measure Information:
Title
HCV risk factors questionnaire
Description
All patients admitted to the one day clinic for surgery and gastroenterology will be asked, after signing an informed consent, to fill in a questionnaire regarding HCV risk factors (1 page). The collection of the questionnaires and the entering of the data into an electronic database will be done in an anonymous way.
Time Frame
up to one day after hospital admission
Title
Positive/Negative Hepatitis C serology
Description
In case of a pre-operative blood sampling, an HCV detection test will be done on the serum as part of the routine pre-operative screening. The sample will be analyzed in the Hospital Laboratory according to the current belgian guidelines regarding hepatitis C virus detection. In patients where no pre-operative blood sample is done, an additional consent will be asked to take a blood sample for HCV detection. In case of a positive test result (positive HCV serology), patients will be contacted. Those patients will be proposed to contact their family doctor (GP) or a specialist of their choice in order to realize a classic work up and discuss therapeutic options if necessary.
Time Frame
up to 10 days after hospital admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients admitted to the one day clinic for surgery and gastroenterology.
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Lasser, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christophe Moreno, MD
Organizational Affiliation
Erasme
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Serste, MD
Organizational Affiliation
CHU St Pierre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Starkel, MD
Organizational Affiliation
UCL - St Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Pierre Hospital
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL St Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21091831
Citation
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Results Reference
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24331294
Citation
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Results Reference
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PubMed Identifier
23241078
Citation
Menzin J, White LA, Nichols C, Deniz B. The economic burden of advanced liver disease among patients with hepatitis C virus: a large state Medicaid perspective. BMC Health Serv Res. 2012 Dec 15;12:459. doi: 10.1186/1472-6963-12-459.
Results Reference
background
PubMed Identifier
16802842
Citation
Wong JB. Hepatitis C: cost of illness and considerations for the economic evaluation of antiviral therapies. Pharmacoeconomics. 2006;24(7):661-72. doi: 10.2165/00019053-200624070-00005.
Results Reference
background
PubMed Identifier
24041346
Citation
Ruggeri M, Coretti S, Gasbarrini A, Cicchetti A. Economic assessment of an anti-HCV screening program in Italy. Value Health. 2013 Sep-Oct;16(6):965-72. doi: 10.1016/j.jval.2013.07.005.
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PubMed Identifier
11868791
Citation
Yoshizawa H. Hepatocellular carcinoma associated with hepatitis C virus infection in Japan: projection to other countries in the foreseeable future. Oncology. 2002;62 Suppl 1:8-17. doi: 10.1159/000048270.
Results Reference
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PubMed Identifier
24713006
Citation
Wedemeyer H, Duberg AS, Buti M, Rosenberg WM, Frankova S, Esmat G, Ormeci N, Van Vlierberghe H, Gschwantler M, Akarca U, Aleman S, Balik I, Berg T, Bihl F, Bilodeau M, Blasco AJ, Brandao Mello CE, Bruggmann P, Calinas F, Calleja JL, Cheinquer H, Christensen PB, Clausen M, Coelho HS, Cornberg M, Cramp ME, Dore GJ, Doss W, El-Sayed MH, Ergor G, Estes C, Falconer K, Felix J, Ferraz ML, Ferreira PR, Garcia-Samaniego J, Gerstoft J, Giria JA, Goncales FL Jr, Guimaraes Pessoa M, Hezode C, Hindman SJ, Hofer H, Husa P, Idilman R, Kaberg M, Kaita KD, Kautz A, Kaymakoglu S, Krajden M, Krarup H, Laleman W, Lavanchy D, Lazaro P, Marinho RT, Marotta P, Mauss S, Mendes Correa MC, Moreno C, Mullhaupt B, Myers RP, Nemecek V, Ovrehus AL, Parkes J, Peltekian KM, Ramji A, Razavi H, Reis N, Roberts SK, Roudot-Thoraval F, Ryder SD, Sarmento-Castro R, Sarrazin C, Semela D, Sherman M, Shiha GE, Sperl J, Starkel P, Stauber RE, Thompson AJ, Urbanek P, Van Damme P, van Thiel I, Vandijck D, Vogel W, Waked I, Weis N, Wiegand J, Yosry A, Zekry A, Negro F, Sievert W, Gower E. Strategies to manage hepatitis C virus (HCV) disease burden. J Viral Hepat. 2014 May;21 Suppl 1:60-89. doi: 10.1111/jvh.12249.
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Citation
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Citation
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Prevalence and Screening of Hepatitis C in Belgium in 2015
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