HCV DETECTION
Quality assurance of Hepatitis B and C care provision in the EU – the Euro Hepatitis Care Index
In European healthcare, with generally good tracking of epidemics, viral hepatitis is a neglected threat, although an estimated 23 million people live with chronic hepatitis. Even in countries with high disease awareness and active prevention policies, less than 40 % of the infections are detected. This means that even in well-organised countries such as UK and Germany, less than one out of five infected people know they carry the infection! In most other countries the detection rate is dramatically lower, which is why in parts of the EU still not even a single case out of one hundred people carrying the virus are diagnosed! This means that millions of Europeans are still unaware of their hepatitis.
A general, rather upsetting impression from this first ever comparison of hepatitis care performance around Europe is that effective action on hepatitis is not seen as a high priority by governments. Not only are the detection rates low or even almost non-existent; identified chronic hepatitis is often left untreated, with less than 20% of the patients receiving treatment. That explains why every year no less than 125 000 Europeans die from various hepatitis-related diseases such as liver cancer, liver cirrhosis, blood infection or HIV.
The lack of political focus may be explained by the “class stigma” of hepatitis diseases. High-risk groups for acquiring and spreading the disease are injection drug users, children of infected mothers, professional sex workers, prison inmates, migrant populations and men having sex with men. These people have little political clout. Policy makers should be aware that among the risk groups are healthcare staff as well as patients on blood dialysis. Lack of political awareness and focus eventually puts the general population at risk.
The Euro Hepatitis Index makes a comprehensive diagnosis of 30 European countries with regard to the capacity to handle the hepatitis threat. The Index not only provides a cross-Europe description of problems and opportunities but also offers an analysis of each country, with a recipe for forming a national hepatitis agenda. Thus the Index can be seen, and hopefully used, as a checklist for repairing and improving the conditions for millions of people in Europe. Implementation of a pan-European best practice would be essential. The EU has the authority to address this issue – but maybe practical life-saving cannot compete with the many rivaling attractions on the steadily expanding EU pallet?
The Health Consumer Powerhouse gratefully acknowledges the financial support from ELPA (European Liver Patient Association) making possible this piece of reality research and the co-operation with EASL (European Association for Study of the Liver).
Brussels, November 6, 2012
Johan Hjertqvist
Founder & President
Health Consumer Powerhouse
Sub-Disciplines & Indicators
Prevention
Screening/Case finding
Access to treatment/Process
Governmental strategy and Patient involvement and rights
Outcomes
Production phases
Content of indicators in the EHepI 2012
External Expert Reference Panel
Methodology
Indicator areas (sub-disciplines)
Scoring in the EHepI 2012
Weight coefficients
Regional differences within European states
Indicator definitions and data sources for the EHepI 2012
Additional data gathering – surveys
Additional data gathering
Threshold value settings
CUTS data
About Hepatitis
General information about hepatitis B and C
Hepatitis Care Timeline
Hepatitis & Liver Research.
Research
General information about hepatitis B and C
“Hepatitis” means inflammation of the liver, most commonly caused by a viral infection.
Viral hepatitis refers to a set of at least five viruses that are known to cause hepatitis: hepatitis A (HAV), hepatitis B (HBV), hepatitis C (HCV), hepatitis D (HDV), and hepatitis E (HEV).
Infection with hepatitis B and C virus (HBV and HCV, respectively) affects the liver and results in a broad spectrum of disease outcomes. An infection with HBV can spontaneously resolve and lead to protective immunity, result in a chronic infection and, in rare cases, cause acute liver failure with a high risk of dying.
HBV: In patients infected in early life, the immune system initially tolerates the infection, which means liver damage and symptoms do not appear[1]. However, after a number of years or decades, the immune systems begin to fight the virus and signs of chronic hepatitis and liver damage appear.
In patients infected as adults or older children (more than five), the immune-response and symptoms of hepatitis develop much more quickly.
An infection with HCV becomes chronic in most cases. People with chronic hepatitis B and/or C virus infection remain infectious to others and are at risk of serious liver disease such as liver cirrhosis or hepatocellular cancer (HCC) later in life[2].
The World Health Organization estimates that worldwide two billion people have been infected with the hepatitis B virus and more than 350 million have chronic (long-term) liver infections. Most are unaware of their infection.
About 600 000 people die every year due to the acute or chronic consequences of hepatitis B.
A vaccine against hepatitis B has been available since 1982. Hepatitis B vaccine is 95% effective in preventing HBV infection and its chronic consequences, and is the first vaccine against a major human cancer.
Every year, 3–4 million people are new infected with the hepatitis C virus. About 150 million people are chronically infected and at risk of developing liver cirrhosis and/or liver cancer. More than 350 000 people die from hepatitis C-related liver diseases every year and the number is increasing. As acute Hepatitis C rarely causes symptoms, it often goes undiagnosed and therefore untreated. There is currently no vaccine for hepatitis C, therefore prevention must be concentrated on awareness and testing, and treatment when appropriate.
[1] Foundation for liver research, 2004
[2] Hepatitis C in the UK, 2011
Adaptable
The European Association for the Study of the Liver (EASL)
The European Association for the Study of the Liver (EASL) is a European professional association for liver disease. Founded in 1966, EASL promotes research on the liver and its pathology and to improve therapy for liver disorders. It hosts the International Liver Congress, attracts the foremost hepatology experts as members and has an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in european liver policy. EASL publishes medical guidelines for liver diseases, and and the Journal of Hepatology. www.easl.eu
The American Association for the Study of Liver Diseases
ClinicalTrials.gov
The European Medicines Agency (EMA)
The Food and Drug Administration (FDA or USFDA)
NATAP
The European Centre for Disease Prevention and Control (ECDC)
International Alliance of Patients' Organizations (IAPO)
The Asian Pacific Association for the Study of the Liver (APASL)
The World Health Organization (WHO)
The Viral Hepatitis Prevention Board (VHPB)
History
Timeline: History of hepatitis B and C
100 AD Greek physician Aretaeus of Cappacocia describes jaundice (icterus) as a severe disease.
100 AD Greek physician Galen believes the liver is the central organ of the body, and detects its connection with the gallbladder and the spleen.
1000 Persian physician Avicenna declares that liver diseases may be detected via the urine.
16th century A Korean child with hepatitis B is buried. Hundreds of years later, traces of the virus will be discovered in the mummified tissue.
1685 Dutch anatomist Govard Bidloo publishes Anatomia Humani Corporis, which also shows a human liver
1770 French anatomist Antoine Portal describes bleeding from esophagal varices.
1875 Victor Charles Hanot first describes jaundice as a consequence of liver cirrhosis, along with other diseases.
1950 The American Association for the Study of the Liver (AASLD) is founded
1953 First successful use of steroids in autoimmune hepatitis, a non-viral liver disease which is caused by the immune system. In the next decades, for lack of efficient drugs and better knowledge, doctors will also unsuccessfully attempt to treat viral hepatitis with steroids.
1958 The International Association for the Study of the Liver (IASL) is founded
1963 Thomas E. Starzl conducts the first human liver transplant. The first patient dies during the surgery, another two only survive for seven and 22 days. However, in the decades to come, liver transplants will save countless lives around the world.
1966 Baruch S. Blumberg discovers the hepatitis B virus
1966 The European Association for the Study of the Liver (EASL) is founded
1967 For the first time, a liver transplanted patient survives for longer than a year
1969 Baruch S. Blumberg develops first hepatitis B vaccine.
1973 Stephen M. Feinstone discovers the hepatitis A virus
1974 Harry B. Greenberg treats four patients with chronic hepatitis B with human leucocyte interferon
1974 Scientists are mystified about hepatitis infections after blood transfusions, which are neither caused by hepatitis A nor B (non-A non-B hepatitis). AM Prince suggests to call these infections “type C hepatitis“. This name is not yet generally accepted by the medical community, as as there is some debate if more than one infectious agent may be behind non-A-non-B hepatitis. The discovery of the hepatitis C virus, the main culprit behind most non-A non-B infections, is still 14 years away
1978 Mario Rizetto and John Gerin discover the hepatitis D virus
1978 The Asian Pacific Association for the Study of the Liver (APASL) is founded
1983 Mikhail Balayan discovers the hepatitis E virus. It is first named “enterically transmitted Non-A Non-B Hepatitis (ETNANB). The hepatitis E virus will receive its name in 1991.
1986 Jay H. Hoofnagle treats ten patients with non-A non-B hepatitis with interferon. The hepatitis C virus has not yet been discovered. The moderate success of this treatment can only be measured in liver enzymes and liver biopsies.
1988 Michael Houghton and Que Lim Choo discover the hepatitis C virus
1989 Christoph E. Broelsch conducts the first living donor liver transplant
1991 Interferon alpha-2b is approved for the treatment of hepatitis C. The cure rates of interferon alpha monotherapy are low (13–17%)
1992 Interferon alpha-2b is approved for the treatment of chronic hepatitis B
1993 Five out of fifteen patients die in a phase II trial with an experimental hepatitis B drug called “Fialuridine“. Two more patients require a liver transplant. The Fialuridine trial is remembered as one of the worst disasters in hepatitis drug development.
1994 Scientists believe they discovered a “hepatitis F“ virus, but this “discovery“ cannot be substantiated. Until this day, no hepatitis F virus is known.
1995 Scientits discover the GB-C virus, which is first called “hepatitis G“. It is still a matter of controversy if this virus actually causes a liver inflammation.
1996 Interferon alpha-2a is approved for hepatitis C
1998 Interferon alfa is combined with ribavirin for the treatment of hepatitis C. This dual therapy has more side effects, but also achieves more cures (29–38%).
1998 Lamivudine is approved for the treatment of chronic hepatitis B
2001 If dectected early, acute hepatitis C can be cured in up to 90% of patients by interferon alpha
2001/2 Peg-interferon alpha 2b and alpha 2a are approved for the treatment of chronic hepatitis C, and combined with ribavirin. This achieves higher cure rates of 38-52%.
2002 Adefovir is approved for chronic hepatitis B
2002 The experimental protease inhibitor BILN 2061 shows efficacy against hepatitis C viruses. The antiviral agent is discontinued because of heart toxicity in animals, however, the discovery is a proof-of-concept which inspires research of new antiviral agents against hepatitis C.
2004 The European Liver Patients Association (ELPA) is founded
2004 Peg-Interferon alfpha 2a is approved for chronic hepatitis B
2004 Ralf Bartenschlager makes the hepatitis C virus visible in the electron microscope; up to this point, hepatitis C could only be detected by blood markers.
2005 Scientists in Denmark succeed in replicating the genotype 1 of the hepatitis C virus in the laboratory.
2005 Entecavir is approved for chronic hepatitis B
2005 FibroScan (elastography) is introduced as a non-invasive liver test
2006 Telbivudine is approved for chronic hepatitis B
2007 World Hepatitis Alliance is founded
2008 Tenofovir is approved for chronic hepatitis B
2010 World Health Organisation recognizes hepatitis A to E as a global challenge. World Hepatitis Day is declared an official WHO awareness day.
2011 Chronic hepatitis E is cured by ribavirin in small trials
2011 Heiner Wedemeyer et al treat hepatitis B/D coinfections with peg-interferon and adefovir. One quarter of the hepatitis D infections are eliminated.
2011 Boceprevir and Telaprevir (protease inhibitors) are approved for the treatment of genotype 1 of hepatitis C. Either drug has to be combined with peg-interferon and ribavirin. The triple treatments have more side effects and complications, but achieve higher cure rates in hepatitis C genotype 1 infections of up to 67 - 75%.
2011 The first interferon-free cures of hepatitis C are achieved in phase II trials.
2012 Several new antiviral hepatitis C agents (including interferon-free treatment regimens) enter phase III trials. The medical and patient community hopes for the approval of the first interferon-free treatments from 2015 onwards.
HCV detection methods encompass a variety of techniques to diagnose Hepatitis C Virus infection. Some common methods include:
ELISA (Enzyme-Linked Immunosorbent Assay): ELISA is a widely used method for detecting the presence of antibodies against HCV in a patient's blood sample. It provides qualitative results and is typically used as a screening test.
PCR (Polymerase Chain Reaction): PCR is a sensitive molecular technique that detects and amplifies HCV RNA present in a patient's blood. It is primarily used for diagnosing acute HCV infection and monitoring treatment response.
qPCR (Quantitative Polymerase Chain Reaction): qPCR is a more precise PCR technique that measures viral RNA levels in the blood. It helps assess the viral load and monitor the effectiveness of antiviral treatment.
Spoligo: Spoligo is a method based on DNA fingerprinting and PCR that identifies specific strains and genotypes of Mycobacterium tuberculosis rather than detecting HCV.
CLIA (Chemiluminescent Immunoassay): CLIA is an advanced immunoassay technique using chemiluminescent reactions to detect HCV antibodies or antigens in a patient's blood. It offers high sensitivity and specificity.
Self-Test: Self-test kits are designed for individuals to test themselves at home using a simple device to detect HCV antibodies. These kits typically use a lateral flow assay for rapid detection, and positive results require further confirmation with a laboratory-based test.
RIBA (Recombinant Immunoblot Assay): RIBA is a supplemental test used to confirm the presence of HCV antibodies in cases where the initial screening test, such as ELISA, is reactive. It helps to differentiate true-positive cases from false-positive results.
Line probe assays: Line probe assays, like INNO-LiPA or VERSANT HCV Genotype Assay, are used to determine the specific genotype and subtypes of HCV. These tests are helpful in guiding treatment decisions, as different genotypes may respond differently to antiviral therapies.
HCV RNA Quantification: This test quantifies the amount of HCV RNA present in a patient's blood using techniques like real-time PCR or transcription-mediated amplification (TMA). It provides information about the viral load, helping to monitor disease progression and treatment response.
Genotypic Resistance Testing: Genotypic resistance testing is performed to identify HCV variants with specific mutations that may confer resistance to certain antiviral drugs. This information helps guide treatment selection and management.
Liver Function Tests: Liver function tests, including liver enzyme tests (AST, ALT), bilirubin levels, and albumin levels, assess the overall health and function of the liver. These tests are important in determining the extent of liver damage caused by hepatitis C infection.
Lateral Flow Assay: Lateral flow assays are rapid, point-of-care tests that use specific antibodies to detect HCV antigens or antibodies in a patient's blood. They provide quick results without the need for specialized laboratory equipment.
These methods serve different purposes depending on the stage of HCV infection, treatment monitoring, or screening. It is important to note that the specific method used may vary based on the healthcare provider and the resources available in a particular setting.
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