Innovation in HCV serology assays – building the change in hepatitis C elimination

8 out 10 people with hepatitis C do not know they are infected.¹

Hepatitis C is an inflammatory liver disease caused by infection with the hepatitis C virus (HCV). HCV can cause both acute and chronic hepatitis resulting in long-term consequences for patients including fibrosis, cirrhosis, liver cancer and death.²

Tremendous diagnostic and therapeutic advances have been made since the discovery of HCV in 1989.³ Since 2016, the availability of highly efficacious therapies, based on direct-acting antivirals, mean that more than 95% of people can be considered cured after treatment.⁴ And yet, the hepatitis C disease burden is still significant – across the world, 58 million people are living with chronic HCV infection.¹ In 2019 alone, there were 1.5 million new infections and 290,000 people died from HCV infection-related causes.¹

The global WHO hepatitis strategy: aiming for a future without viral hepatitis

Whilst viral hepatitis can affect anyone, infections via injecting drugs is the major contributor to the hepatitis C epidemic globally, and the people and communities most underserved by health systems are disproportionately affected.¹

In 2022, the World Health Organization (WHO) approved a global health sector strategy to achieve elimination of viral hepatitis C, as a major public health threat by 2030.⁶ The WHO targets apply to all populations affected and at risk of viral hepatitis C.⁶

Roche is committed to supporting the fight to eliminate hepatitis

Viral hepatitis can be stopped in its tracks. Early detection of an HCV infection is crucial to allow treatment, prevent or delay disease progression, and effectively disrupt virus transmission.^{2, 7}

As a community, we need to employ all available tools and resources at our disposal – effective diagnosis is critical to the success of the HCV elimination strategy.⁶

Simplifying the pathway to hepatitis C diagnosis through innovation – the Elecsys^® HCV Duo immunoassay

Diagnosis of acute hepatic injury is made by measurement of markers of liver function or health, such as the liver enzymes alanine aminotransferase [ALT] and aspartate transaminase [AST].⁹ For access to effective treatment, it is important to determine whether the causative agent of hepatitis is viral in origin.² The Elecsys^® HCV Duo assay expands Roche’s comprehensive viral hepatitis test portfolio, which includes molecular and serology solutions, to help diagnose and manage patients with acute or chronic viral hepatitis infection.

Markers used to detect HCV infection appear in the body at different times during the course of infection.¹⁰

Direct viral markers, such as HCV core antigen (HCV cAg) and HCV RNA, appear earlier than anti-HCV antibodies which occur approximately 6 to 12 weeks after infection.¹⁰

As per current guidelines, the standard HCV screening and diagnosis algorithm is based on the detection of anti-HCV antibodies as the first step, followed by HCV RNA or HCV cAg.^{2, 12, 13}

Addition of simultaneous HCV cAg measurement provides opportunities for the Elecsys^® HCV Duo assay to simplify the HCV diagnostic pathway — as a surrogate marker for HCV RNA, a positive HCV cAg result indicates active HCV infection (viremia) as described in the EASL most recent guidelines — and could eliminate the need for additional subsequent confirmatory testing in a substantial proportion of tested samples.*
 

*Due to the lower analytical sensitivity of HCV cAg  compared with HCV RNA testing, anti-HCV antibody-positive/HCV cAg-negative samples should have a confirmatory HCV RNA test to exclude a false-negative HCV cAg result.^{2, 12, 13}

Usage of the Elecsys^® HCV Duo assay

• In conjunction with other laboratory results and clinical information, may be used to aid in the diagnosis of, and the screening for, HCV infection
• Used as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissue, and organs, especially in territories where guidelines recommend anti-HCV and HCV antigen testing
• Used as an aid in the selection of the confirmatory testing algorithm for reactive samples

Patients benefit from early diagnosis

HCV infection is often not identified in its early stages as the majority of newly infected patients will be asymptomatic, and can remain so until serious liver damage has occurred.¹³ There can be a lack of specific clinical symptoms in the early stage in those who do present with symptoms,¹³ yet only people who know they are infected can be treated. The earlier HCV infection is diagnosed, the earlier optimum treatment can be offered.

Current guidelines recommend testing in the general population, under specific conditions of prevalence, and/or targeted testing in particular at-risk groups.^{12, 13}

If detected, hepatitis C is treatable & curable – when patients are linked early to treatment, testing with the Elecsys^® HCV Duo assay can reduce the risk of progression to cirrhosis, end-stage liver disease and hepatocellular carcinoma^{2, 7}