Prevalence and Screening of Hepatitis C in Belgium in 2015

NCT02393365 | Completed

• 1 other identifier: CHUB-HCV screening
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; HCV; screening

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

HCV screening

OTHER

All patients admitted to the one day clinic for surgery and gastroenterology.

Other: Questionnaire; Procedure: HCV serology

Interventions

Questionnaire OTHER

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.

HCV screening

HCV serology PROCEDURE

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.

HCV screening

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the one day clinic for surgery and gastroenterology.

You may not qualify if:

• none

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (4)

St Pierre Hospital

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

Erasme

Brussels, 1070, Belgium

Location

UCL St Luc

Brussels, 1200, Belgium

Location

Related Publications (13)

• Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011 Feb;17(2):107-15. doi: 10.1111/j.1469-0691.2010.03432.x.

  PMID: 21091831 BACKGROUND

• 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. No abstract available.

  PMID: 24331294 BACKGROUND

• 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.

  PMID: 23241078 BACKGROUND

• 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.

  PMID: 16802842 BACKGROUND

• 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.

  PMID: 24041346 BACKGROUND

• 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.

  PMID: 11868791 BACKGROUND

• 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.

  PMID: 24713006 BACKGROUND

• McGarry LJ, Pawar VS, Panchmatia HR, Rubin JL, Davis GL, Younossi ZM, Capretta JC, O'Grady MJ, Weinstein MC. Economic model of a birth cohort screening program for hepatitis C virus. Hepatology. 2012 May;55(5):1344-55. doi: 10.1002/hep.25510. Epub 2012 Mar 18.

  PMID: 22135116 BACKGROUND

• 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.

  PMID: 12148442 BACKGROUND

• Dore GJ, Ward J, Thursz M. Hepatitis C disease burden and strategies to manage the burden (Guest Editors Mark Thursz, Gregory Dore and John Ward). J Viral Hepat. 2014 May;21 Suppl 1:1-4. doi: 10.1111/jvh.12253.

  PMID: 24713003 BACKGROUND

• McEwan P, Ward T, Yuan Y, Kim R, L'italien G. The impact of timing and prioritization on the cost-effectiveness of birth cohort testing and treatment for hepatitis C virus in the United States. Hepatology. 2013 Jul;58(1):54-64. doi: 10.1002/hep.26304. Epub 2013 May 27.

  PMID: 23389841 BACKGROUND

• 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.

  PMID: 22895429 BACKGROUND

• Van Damme P, Laleman W, Starkel 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.

  PMID: 25090833 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Luc Lasser, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Christophe Moreno, MD

  Erasme

  PRINCIPAL INVESTIGATOR

• Thomas Serste, MD

  CHU St Pierre

  PRINCIPAL INVESTIGATOR

• Peter Starkel, MD

  UCL - St Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 19, 2015
• Study Start: March 10, 2015
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

BE (4)