Prevalence and Screening of Hepatitis C in Belgium in 2015
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

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.
    


Intervention name(s): Questionnaire; HCV serology
Intervention type(s): Other; Procedure
Intervention description(s): 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.; 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatitis C; HCV; screening