Article

Viral Hepatitis

Reliable, scalable, and sustainable diagnostic solutions to help support the management and eradication of viral hepatitis

Shining a light on viral hepatitis

Working towards eliminating hepatitis with integrated solutions

Viral hepatitis (caused by hepatitis A-E virus) is a major public health threat and a leading cause of morbidity and death worldwide with an annual mortality similar to that of other major infectious diseases such as HIV and tuberculosis., 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.1

An estimated 304 million people worldwide were living with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) in 2022. Only 13% of people living with chronic HBV and 36% of people living with HCV had been diagnosed between 2015 and 2022, leaving many unaware of their infection status.1 If left undiagnosed and untreated, these infections may progress to severe diseases such as cirrhosis, hepatocellular carcinoma, and end-stage liver failure.1

At Roche, patient-centricity is paramount, driving our commitment to continually enhance our trusted infectious disease diagnostics portfolio. Recognizing that investing in diagnostic solutions entails long-term partnerships, we offer integrated solutions tailored to various throughputs and disease areas. These solutions are designed to address the evolving needs of countries striving to eliminate viral hepatitis. Our team of Roche experts stands ready to support your laboratory and ultimately, country or region in achieving your objectives in testing and disease elimination.

Hepatitis is a silent killer

Viral hepatitis accounts for 1.34 million deaths globally—including liver cancer, acute cases, and cirrhosis3—and exceeded the number of deaths caused by HIV infection, tuberculosis, or malaria in 2018.3 By 2040, deaths from chronic hepatitis are expected to exceed the combined mortality associated with HIV, tuberculosis, and malaria.3

Types of hepatitis

Hepatitis A (HAV) virus

Hepatitis A is a liver inflammation caused by the hepatitis A virus (HAV), transmitted through contaminated food, water, or direct contact. Most recover fully with lifelong immunity, but a small proportion can develop severe complications. Risk factors include poor water quality and hygiene. In 2016, WHO estimated over 7,000 persons died from hepatitis A worldwide (accounting for 0.5% of the mortality due to viral hepatitis). Vaccination is effective for prevention.4

Hepatitis B (HBV) and hepatitis C (HCV) virus

HBV infections are severely underdiagnosed and not curable—as many as 95% of infants infected with HBV develop chronic infections. Meanwhile, HCV infections are usually asymptomatic, causing approximately 55-85% of cases to develop into chronic infections, leading to significant (and unnecessary) mortality. Despite these numbers, vaccines exist for HBV and HCV, and are curable with antiviral medicines which are effective for more than 95% of persons with hepatitis C infection5,6

HBV and HCV can be transmitted through various routes, including:5,6

  • Infections by blood transfusion or organ transplants
  • Sexual activity where blood exchange is possible
  • Drug usage by sharing needles or syringes
  • Non-sterile equipment (medical, dental, tattoo, or body piercings)
  • Sharing of contaminated personal items, like razors or toothbrushes
  • Mother-to-child transmission (MTCT)

Hepatitis D virus (HDV)15

HDV relies on hepatitis B virus (HBV) for replication and affects about 5% of those with chronic HBV infection globally. Infection occurs through co-infection with both viruses or after HBV infection (super-infection). High-risk groups include indigenous populations, dialysis patients, and injection drug users. Global HBV vaccination has reduced HDV infections. HDV and HBV co-infection is severe, leading to rapid liver-related complications. Prevention is through HBV immunization, but treatment success rates are limited.

Hepatitis E virus (HEV)

HEV is recognized as the fifth major cause of human viral hepatitis and is likely the leading cause of acute hepatitis and jaundice worldwide. As per the World Health Organization, around 20 million people globally are infected with HEV each year, resulting in roughly 3.3 million symptomatic cases and about 44,000 fatalities.8

Hepatitis E genotypes 1 and 2 are common in developing countries and are transmitted fecal-orally by contaminated water and food. On the other hand, genotypes 3 and 4 are common in developed countries and can occasionally transmit to humans zoonotically through close contact with infected animals or the consumption of contaminated animal products.

Critical elements to curb the burden

Viral hepatitis is a major public health threat and a leading cause of death worldwide. Diagnostics and effective testing strategies are crucial in curbing the hepatitis burden. However, there are major gaps in testing and treatment, specifically among economically disadvantaged regions, rural and displaced populations, and at-risk groups.

The World Health Organization (WHO) 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.9 For the most affected populations, testing and treatment remain beyond reach.

Elimination goals

In response to the global burden of hepatitis, the World Health Assembly approved WHO's global hepatitis strategy in 2016. This strategy aims for the global elimination of viral hepatitis by 2030, setting targets of achieving a 90% reduction in new cases and a 65% reduction in deaths.9

For countries working to reach elimination, disease awareness and education are effective upfront strategies for countering the frequent asymptomatic presentation of viral hepatitis. Encouraging testing for everybody may accelerate elimination efforts while also helping to address stigmas often associated with infection. An increasing number of countries are starting to work towards eliminating hepatitis, specifically HBV and HCV, including Egypt, France, Georgia, Iceland, Mongolia, Spain, and Switzerland.10

Looking ahead

At Roche, we envision a world where viral hepatitis transmission is halted and everyone living with viral hepatitis has access to diagnostic testing along with safe, affordable, and effective prevention, care, and treatment services.

Reliable hepatitis screening solutions empower clinicians to pinpoint major health threats and devise tailored responses. This could involve local prevention measures, personalized post-infection treatments, or advocacy for broader policy reforms nationally or globally.

Roche has remained committed to the global fight against viral hepatitis and other infectious diseases through reliable screening solutions and will continue to serve as a trusted partner in building a sustainable healthcare system infrastructure in every region for disease prevention and management.

Benefits of Roche diagnostic and management solutions for viral hepatitis

A comprehensive testing solution

The right hepatitis 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. Roche’s comprehensive hepatitis diagnostic portfolio offers powerful tools designed to address key population needs and support the objectives outlined in WHO's global hepatitis strategy. With our solutions, healthcare providers have the capability to:

  • Assess liver function with enzyme testing
  • Screen and diagnose with immunoassays
  • Monitor disease progression with immunoassays
  • Use reliable diagnostic solutions for HAV, HBV, HCV, and HEV infections
  • Determine HCV genotype
  • Monitor viral load to assess HBV and HCV treatment response
  • Test for hepatocellular carcinoma (HCC) biomarkers

HCV diagnosis through innovation

Early detection, confirmation of active infection, and viral load monitoring for HCV infections are crucial diagnostic steps to allow treatment, prevent or delay disease progression, and effectively disrupt virus transmission.

Roche’s HCV assays offers:

  • In vitro qualitative detection of antibodies to HCV and HCV antigens in serum and plasma11
  • Single specimen testing that increases convenience and reduces the number of clinic visits that a patient needs to make12
  • High sensitivity for early PCR detection of infection, with 100% sensitivity for different stages of HCV infection11
  • Detection of all clinically relevant HCV genotypes that allows testing relevant for all geographical regions13
  • Significant shortening of the diagnostic window period by up to 3 weeks compared with traditional testing regimens14

Delivering optimal HBV results

Roche Diagnostics offers a comprehensive solution for Hepatitis B infection. Our CE- and FDA-marked portfolio enhance laboratory efficiency and patient management. With low sample volume requirements and fast turnaround time, you can obtain accurate results quickly.

Our assays provide excellent coverage for genotypes and mutants, ensuring precise diagnosis and monitoring.17,18 They also offer high sensitivity for seroconversion.19 Our first-line screening assays have excellent specificity, reducing the need for confirmatory testing. Ready-to-use reagents and advanced technologies further streamline your workflow.

Overall, our HBV Portfolio provides high-performance diagnostic markers for optimal screening, diagnosis, and therapy monitoring of Hepatitis B.

Closing the HEV diagnostic gap

While HEV infection often remains asymptomatic and viral clearance typically occurs spontaneously in most cases, it can pose severe risks for individuals with certain predisposing risk factors, such as underlying chronic liver disease, pregnancy, and immunocompromised states, leading to potentially fatal outcomes like severe hepatitis and liver failure.20

To bridge this diagnostic gap, we offer highly reliable automated serology assays designed to detect both acute and past HEV infections, as well as to screen blood donors for potential transmission. Our anti-HEV assays are designed for the highly sensitive and specific detection of HEV infection, facilitating:

  • Diagnosis of acute or recently acquired HEV infection
  • Differential diagnosis of acute hepatitis
  • Assessment of HEV immunity status
  • Evaluation of the risk of HEV reinfection
  • Detection of emerging zoonotic pathogens in donor blood to mitigate the risk of transfusion transmission21

The right tests to support diagnostic best practice

Diagnostic testing for HAV infection is a critical tool in the differential diagnosis of viral hepatitis as hepatitis A cannot be differentiated from other types of viral hepatitis on the basis of clinical features alone. Serology testing for HAV is an essential component of clinical diagnosis, disease prevention, and public health management. Roche offers a serology test panel for confirmation of infection and immunity/vaccination verification.22,23

  • Diagnosis of acute or recently acquired HAV infection
  • Differential diagnosis of acute hepatitis
  • Assessment of HAV immunity status
  • Detection of HAV in donor blood to mitigate the risk of transmission via blood products

Comprehensive solution portfolio and partnership for enhanced value

With the increasing complexity, breadth, and volume of infectious disease testing, labs want a long-term, collaborative partner that understands their needs and helps them build a lab that delivers the best possible service, both pre- and post-sale. Roche offers strategic partnerships, acting as a trusted ally to healthcare providers by:

  • Anticipating and supporting all phases of lab operations to ensure optimal performance and continuous improvement through our Roche 360° Service Solutions
  • Providing expert consultancy to optimize the integration of data and resources
  • Continuous investment in innovative solutions to ensure we meet evolving healthcare needs
  • Offering tailored solutions through a broad range of products, integration, and automation to help our customers reach operational excellence
An illustration of a group of people in the park that are affected by a range of infectious diseases

Discover our comprehensive pocket guide for the diagnosis of viral hepatitis

Empower informed decisions with our valuable viral hepatitis testing guide. This guide includes testing algorithms and a visual overview of the serological diagnostic markers at each stage of infection for hepatic A, B, C, and E. The tests available and result interpretation are also included.

An illustration of a group of people in the park that are affected by a range of infectious diseases

Whitepaper: Current capabilities and shortcomings of Hepatitis E virus (HEV) diagnosis

Download our complimentary whitepaper offering an in-depth exploration into HEV virology and epidemiology, available diagnostic approaches for HEV infection, and opportunities for enhancing diagnostic tools.

An illustration of a group of people in the park that are affected by a range of infectious diseases

Interactive infectious diseases testing guide

Unlock insights with our interactive infectious diseases testing guide and take some of the world’s most notorious infectious agents to the test. Discover pathogen-specific markers, examine comprehensive testing algorithms, and simulate diagnostic sequences.

Committed to elimination with continuous innovation and support

Explore the full product portfolio for viral hepatitis
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References

  1. World Health Organization. Global Hepatitis Report 2024 [Internet; updated 2024 Apr 9; cited 2024 May 08]. Available from: https://www.who.int/publications/i/item/9789240091672.
  2. Cooke GS et al. Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2019;4(2):135-184.
  3. Thomas DL. Global elimination of chronic hepatitis. N Engl J Med. 2019;380:2041-2050.
  4. World Health Organization. Hepatitis A Key Facts [Internet; cited 2024 May 8]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-a.
  5. World Health Organization. Hepatitis B Key Facts [Internet; cited 2024 April 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.
  6. World Health Organization. Hepatitis C Key Facts [Internet; cited 2024 April 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c.
  7. World Health Organization. Hepatitis D Key Facts [Internet; cited 2024 May 8]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-d.
  8. World Health Organization. Hepatitis E Key Facts [Internet; cited 2024 April 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.
  9. World Health Organization. Hepatitis [Internet; cited 2024 April 5]. Available from: https://www.who.int/health-topics/hepatitis/elimination-of-hepatitis-by-2030.
  10. CDA Foundation. HCV Elimination Targets [Internet; cited 2024 April 5]. Available from: https://cdafound.org/dashboard/polaris/maps.html.
  11. Elecsys® Anti-HCV II Mat. Nos. 08836981190 & 08837031190: V2.0, 2024-04; Mat. No. 08837058190: V1.0, 2023-09.
  12. Elecsys® HCV Duo (Mat. No. 08110697190) method sheet, V3.0 2023-03.
  13. cobas® HCV Test. Method Sheet. 09198865001-05EN  Doc Rev. 5.0  57
  14. Majchrzak M et al (2022). Multicenter performance evaluation of the Elecsys HCV Duo immunoassay. J. Clin. Virol;156:105293.
  15. World Health Organization (WHO).  https://www.who.int/news-room/fact-sheets/detail/hepatitis-d#:~:text=HDV%20infection%20occurs%20when%20people,B%20(super%2Dinfection).  Accessed 28May2024
  16. cobas HBV, Quantitative nucleic acid test for use on the cobas 5800/6800/8800 Systems - US-IVD.  Instructions for Use. 09198938001-04EN  Doc  Rev.  4.0
  17. cobas HBV, Quantitative nucleic acid test for use on the cobas 5800/6800/8800 Systems - CE-IVD.  Instructions for Use.  09040820190-03EN Doc  Rev.  3.0
  18. Elecsys Anti-HBe. Instructions for Use USA.  11820613501 V1.0
  19. Elecsys Anti-HBe. Instructions for Use.  11820613500 V18.0
  20. World Health Organization (WHO).  https://www.who.int/news-room/fact-sheets/detail/hepatitis-d#:~:text=HDV%20infection%20occurs%20when%20people,B%20(super%2Dinfection).  Accessed 28May2024
  21. Elecsys® Anti-HEV IgM. Material Numbers 09056246190 and 09056254190, Method Sheet 2023-09, V1.0.
  22. Elecsys® Anti-HAV IgM method sheet, V17.0 2022-06.
  23. Elecsys® Anti-HAV II method sheet, V3.0 2022-03.