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Scientific Calendar May 2021

Reducing the loss in follow-up for hepatitis C patients

Hepatitis C virus (HCV) infection is a serious public health problem worldwide. Globally, 71 million people are chronically infected with HCV and each year an estimated 399,000 people die from liver cirrhosis or hepatocellular carcinoma (HCC) due to chronic hepatitis C. HCV causes both acute and chronic infection. Acute HCV infection is usually asymptomatic and is only very rarely (if ever) associated with life-threatening disease. About 15–45% of infected individuals spontaneously clear the virus within six months of infection without any treatment. The remaining 55–85% will develop chronic HCV infection. HCV is the biggest single global driver for liver transplantation.

Depending on the country, HCV infection may be concentrated in key populations, for example among people who inject drugs (PWID), males who have sex with males (MSM), and others. HCV can also occur in the general population with percutaneous exposures, such as tattoos and needle stick injuries.

For any country, the number of steps that a person must go through to be diagnosed and treated for hepatitis C poses one of the biggest challenges to achieve elimination. Individuals who are tested antibody-positive by a screening test must be tested again for chronic active infection using either an RNA test or a core antigen test to confirm the presence of the hepatitis C virus. The introduction of modern, pan-genotypic direct acting antivirals (DAAs) has revolutionised the treatment of HCV. As a result, the diagnostic testing algorithm has been simplified and hepatitis C genotyping is no longer necessary1. However, many clinics and smaller hospital laboratories still lack the resources to perform confirmatory molecular testing and so are forced to send patient samples away for testing. Many patients wait for weeks for their test results necessitating a subsequent follow-up appointment at the local clinic.

Indirect patient cost is a significant burden. When samples are sent away for molecular testing, a significant number of patients do not return for their results and the required treatment.2 The patient drop-out rate and indirect patient cost can be significantly reduced by performing the molecular confirmatory HCV RNA test on site, using the Genedrive HCV ID Kit.

  1. Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection, Updated version, July 2018. Geneva: World Health Organization 2018.  www.who.int/hepatitis/publications/hepatitis-c-guidelines-2018/en/
  2. https://www.worldhepatitisalliance.org/missing-millions/wp-content/uploads/2018/07/Overcoming-the-barriers-to-diagnosis-white-paper-1.pdf

What is one of the biggest challenges in achieving elimination of hepatitis C?

HCV mainly affects lower income countries. Therefore, the WHO has a focus on these countries.     

Direct-acting antiviral treatment has been expensive and therefore currently only available to privately insured patients.

Only laboratory-based quantitative HCV viral load tests should be used for the diagnosis of HCV-positive individuals.

Vaccination against HCV is the first choice in the fight against hepatitis C infections and supported by the WHO. 

Massive screening and direct-acting antiviral (DAA) therapies for risk groups can eliminate this global health burden.

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Background

1. HCV mainly affects lower income countries. Therefore, the WHO has a focus on these countries.     

Wrong: HCV affects the global population: However, certain behaviours and circumstances are associated with a higher risk:

  • People who have had blood transfusions, blood products, or organ transplants prior to the time that sensitive tests for HCV were introduced for blood screening.
  • Health care workers exposed to needlestick injuries.
  • Injection drug users, including those who may have used drugs once many years ago.
  • Infants born to HCV-infected mothers.

Other groups who appear to be at slightly increased risk for hepatitis C are:

  • People with high-risk sexual behaviour, multiple partners, and sexually transmitted diseases, notably those that are HIV-coinfected.
  • People who snort cocaine using shared equipment.
  • People who have shared toothbrushes, razors and other personal items with a family member that is HCV-infected.

Source: https://www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_c/whos_at_risk.htm

2. Direct-acting antiviral treatment (DAA) is expensive and therefore currently only accessible to privately insured patients.

Wrong: According to a report published by the WHO in January this year (global progress report on accelerating access to hepatitis C diagnostics and treatment) some low- and middle-income countries have achieved a 20-fold increase in the number of people treated with safe and effective direct-acting antiviral drugs between 2015 and 2018.

Source: https://www.who.int/news/item/27-01-2021-who-highlights-progress-in-accelerating-access-to-hepatitis-c-diagnostics-and-treatment-in-low-and-middle-income-countries

3. Only laboratory-based quantitative immunoassays tests should be used for the diagnosis of HCV-positive individuals.

Wrong: Of course, the accessibility of quality-assured diagnostics was mainly provided by central laboratories, but nowadays affordable point-of-care devices are available to support diagnostic testing and thus treatment initiation for individuals confirmed to have HCV.  Therefore, it is important to adapt the diagnostic testing processes to the needs of health care professionals to support the treatment of these patient groups.  

Source: Accelerating access to hepatitis C diagnostics and treatment: https://www.who.int/publications/i/item/9789240019003

4. Vaccination against HCV is the first choice in the fight against hepatitis C infections and supported by the WHO. 

Wrong: After thirty years since the discovery of the hepatitis C virus, efforts in the development of prophylactic vaccines against HCV have been unsuccessful. Even if promising candidates are investigated, it will still take time before a vaccine will become available.

Source: Hepatitis C Virus Vaccine: Challenges and Prospects
Vaccines 2020, 8(1), 90; https://doi.org/10.3390/vaccines8010090

5. Massive screening and direct-acting antiviral (DAA) therapies for risk groups can eliminate this global health burden.

Correct: The clear goal of the WHO campaign is to eliminate the burden of HCV, through massive screening and treatment programmes in countries, by 2030. Therefore, the WHO supports all efforts to improve diagnostics and treatment for HCV and its related diseases globally. Low- and middle-income countries get more support to access affordable new treatment regimens, drugs and diagnostics.

Source: The phases of hepatitis C elimination: achieving WHO elimination targets
Lancet Gastroenterol Hepatol. 2021 Jan;6(1):6-8. doi: 10.1016/S2468-1253(20)30366-6.

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