Innovation

Viral Hepatitis

Curbing the burden of viral hepatitis

Viral hepatitis is a major public health threat and a leading cause of death worldwide with an annual mortality similar to that of other major infectious diseases such as HIV and tuberculosis.1,2

From the discovery of the first specific biomarker of viral hepatitis in 1963, hepatology became a focused subject.3 Progress has been made—including the development of vaccines and cures—yet viral hepatitis remains a global health burden with many cases of acute and chronic infection exhibiting no or mild symptoms.4

Today, an estimated 90% of the 325 million people worldwide living with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) are unaware of their status.5 If left undiagnosed and untreated, these infections may progress to severe diseases such as cirrhosis, hepatocellular carcinoma and end-stage liver failure.6

Hepatitis is a silent killer

Viral hepatitis accounts for 1.34 million deaths globally—including liver cancer, acute cases, and cirrhosis7—and exceeded the number of deaths caused by HIV infection, tuberculosis, or malaria in 2018.7

  • HBV infections are severely underdiagnosed and not curable—as many as 80-90% of infants infected with HBV during the first year of life develop chronic infections.8
  • HCV infections are usually asymptomatic, causing approximately 70% of cases to develop into chronic infections, leading to significant (and unnecessary) mortality.9
  • By 2040, deaths from chronic hepatitis are expected to exceed the combined mortality associated with HIV, tuberculosis & malaria.7

Despite these numbers, vaccines exist for HBV and antiviral medicines can cure more than 95% of persons with hepatitis C infection.9,10 However, for most affected populations, testing and treatment remain beyond reach.4

A notable shift in global focus

Hepatitis can affect both the general health and quality of life of infected populations, resulting in significant economic burden on countries.6

However, despite this prevalence, viral hepatitis receives relatively little funding and attention from global health policy makers and donors compared to diseases like HIV, tuberculosis and malaria.6

A study conducted by the World Health Organization (WHO) found that an estimated 4.5 million premature deaths could be prevented in low- and middle-income countries by 2030 through the use of vaccination, diagnostic tests, medicines, and education campaigns for hepatitis.4

 

In response, the World Health Assembly approved in 2016 a global strategy to take action against viral hepatitis11

90%

reduction in new cases of chronic hepatitis B and C by 2030

65%

reduction in hepatitis-related deaths

80%

of eligible people with chronic hepatitis B and C infections treated by 2030

 

Education is an essential part of elimination

 

For countries working to reach elimination, disease awareness campaigns can be an effective upfront strategy for countering the frequent asymptomatic presentation of viral hepatitis. Encouraging high-risk populations to seek out testing may accelerate elimination efforts while also helping to address stigmas often associated with infection.

The components of a comprehensive viral hepatitis testing solution

Identifying and managing an infection with holistic, scalable, and sustainable testing solutions.

The right diagnostic portfolio offers a broad range of tools that address key population needs—from increasing accessibility to decreasing the number of patients lost to follow-up and beyond.

  • Assessing liver function with enzyme testing

  • Immunoassays for screening and diagnosis

  • Immunoassays for monitoring disease progression

  • Confirmatory molecular testing of active HBV, HCV, and HEV infections

  • Determining HCV genotype  

  • Monitoring viral load to assess HBV  and HCV treatment response

  • Testing for hepatocellular carcinoma (HCC) biomarkers

Scalability, sustainability, and support.

Investing in diagnostic solutions requires long-term partnerships. For this reason, Roche’s integrated solutions are designed to meet the current and future needs of countries looking to eliminate viral hepatitis.


Elimination in action today


An increasing number of countries are starting to work towards eliminating HBV and HCV, including Egypt, France, Georgia, Iceland, Mongolia, Spain, and Switzerland.12

Learn more about Egypt's road to HCV elimination and Roche's efforts.

Committed to elimination with continuous innovation and support

Learn more about our solutions

Determine total antibodies against HAV

Used as an aid to detect a past or existing HAV infection and also to monitor the immune response after vaccination.

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Test for IgM-antibodies to HAV

Used in the differential diagnosis of acute hepatitis to determine a hepatitis A infection.

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Hepatitis B surface antigen (HBsAg) test

Specifically designed to detect a multitude of HBV mutants. 

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Hepatitis B surface antigen (HBsAg) quantitative test

Quantify HBsAg levels to monitor natural disease progression and predict the response to antiviral treatment.

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Hepatitis B surface antigen (HBsAg) antibody test

Check the necessity and success of vaccination and monitor the course of disease following acute hepatitis B infection.

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Hepatitis B core antigen detection

Determine anti-HBc in association with other hepatitis B tests permits the diagnosis and monitoring of HBV infections.

Anti-HBc IgM antibody detection

Determine whether a patient has acute or chronic HBV infection, is susceptible to infection, or is immune to HBV as result of prior infection or vaccination.

Determine total antibodies against hepatitis B e antigen

For use in monitoring the course of HBV infection and the effect of treatment for chronic hepatitis B.

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Qualitative determination of hepatitis B e antigen

Confidently mark the transition from the immune-active phase of the disease to the inactive carrier state.

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Detect antibodies against HCV

Demonstrate the presence of antibodies against HCV during acute and chronic infection, and after a resolved infection.

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Duplex test for parvovirus B19 and HAV

A multi-dye, duplex real-time PCR test for parvovirus B19 (B19V) and hepatitis A virus (HAV).

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HBV DNA detection and viral load measurement

Nucleic acid amplification test for the quantitation of hepatitis B virus DNA in human EDTA plasma or serum of HBV-infected individuals.

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Dual-probe HCV viral load testing

Precisely distinguish true signals from background noise for more accurate quantification of viral loads.

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Detect emerging zoonotic pathogens in donor blood

Manage the hepatitis E virus in plasma pools and identify HEV-contaminated units while increasing processing efficiency.

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Easy plasma collection device for viral load

For use in conjunction with clinical presentation and other laboratory markers for the clinical management of infected patients.

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Improving patient access to results

Empower patients to play a more active role in their health, with easy access to result information quickly, no matter their location.

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References

  1. World Health Organization. Viral hepatitis: a hidden killer gains visibility. https://www.who.int/publications/10-year-review/hepatitis/en/. Accessed September 1, 2020.

  2. Cooke GS, Andrieux-Meyer I, Applegate TL, et al. Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission [published correction appears in Lancet Gastroenterol Hepatol. 2019 May;4(5):e4]. Lancet Gastroenterol Hepatol. 2019;4(2):135-184. doi:10.1016/S2468-1253(18)30270-X

  3. Gerlich WH. Medical virology of hepatitis B: how it began and where we are now. Virol J. 2013;10:239. Published 2013 Jul 20. doi:10.1186/1743-422X-10-239

  4. World Health Organization. Hepatitis. www.who.int/health-topics/hepatitis. Accessed September 1, 2020.

  5. World Health Organization. World Hepatitis Day 2017: WHO guide on advocacy and communications. https://www.who.int/campaigns/hepatitis-day/2017/campaign-brief.pdf?ua=1. Accessed September 1, 2020.

  6. World Health Organization. The global burden of viral hepatitis: better estimates to guide hepatitis elimination efforts. https://www.who.int/mediacentre/commentaries/better-estimates-hepatitis/en/. Accessed September 1, 2020.

  7. Thomas DL. Global elimination of chronic hepatitis. N Engl J Med. 2019;380:2041-2050.

  8. World Health Organization. Hepatitis B. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b. Accessed September 17, 2020.

  9. World Health Organization. Hepatitis C. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c. Accessed September 1, 2020.

  10. World Health Organization. Hepatitis B vaccine. https://www.who.int/ith/vaccines/hepatitisB/en/. Accessed September 17, 2020.

  11. World Health Organization. Combating hepatitis B and C to reach elimination by 2030. Advocacy Brief, 2016.

  12. CDA Foundation. HCV Elimination Targets. https://cdafound.org/dashboard/polaris/maps.html. Accessed September 1, 2020.