Hepatitis C Clinical Trial
Official title:
Prevalence and Screening of Hepatitis C in Belgium in 2015
Verified date | April 2019 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10000 |
Est. completion date | December 17, 2018 |
Est. primary completion date | December 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - All patients admitted to the one day clinic for surgery and gastroenterology. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels | |
Belgium | Erasme | Brussels | |
Belgium | St Pierre Hospital | Brussels | |
Belgium | UCL St Luc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital |
Belgium,
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European Association for Study of Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014 Feb;60(2):392-420. doi: 10.1016/j.jhep.2013.11.003. Epub 2013 Dec 9. Erratum in: J Hepatol. 2014 Jul;61(1):183-4. — View Citation
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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. — View Citation
Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, Jewett A, Baack B, Rein DB, Patel N, Alter M, Yartel A, Ward JW; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012 Aug 17;61(RR-4):1-32. Erratum in: MMWR Recomm Rep. 2012 Nov 2;61(43):886. — View Citation
Van Damme P, Laleman W, Stärkel P, Van Vlierberghe H, Vandijck D, Hindman SJ, Razavi H, Moreno C. Hepatitis C epidemiology in Belgium. Acta Gastroenterol Belg. 2014 Jun;77(2):277-9. — View Citation
Van Damme P, Thyssen A, Van Loock F. Epidemiology of hepatitis C in Belgium: present and future. Acta Gastroenterol Belg. 2002 Apr-Jun;65(2):78-9. Review. — View Citation
Wedemeyer H, Duberg AS, Buti M, Rosenberg WM, Frankova S, Esmat G, Örmeci N, Van Vlierberghe H, Gschwantler M, Akarca U, Aleman S, Balik I, Berg T, Bihl F, Bilodeau M, Blasco AJ, Brandão 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, Ergör G, Estes C, Falconer K, Félix J, Ferraz ML, Ferreira PR, García-Samaniego J, Gerstoft J, Giria JA, Gonçales FL Jr, Guimarães Pessôa M, Hézode C, Hindman SJ, Hofer H, Husa P, Idilman R, Kåberg M, Kaita KD, Kautz A, Kaymakoglu S, Krajden M, Krarup H, Laleman W, Lavanchy D, Lázaro P, Marinho RT, Marotta P, Mauss S, Mendes Correa MC, Moreno C, Müllhaupt B, Myers RP, Nemecek V, Øvrehus 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, Stärkel 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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to one day after hospital admission | |
Primary | 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. | up to 10 days after hospital admission |
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