World Hepatitis Day: gaps in testing, treatment open opportunities for investors

Gaps in testing, monitoring, and treatment of hepatitis have opened opportunities for investors with some interest in healthcare.

Hepatitis C virus (HCV) transmission is most commonly associated with direct exposure to blood, via blood transfusions, health-care-related injections, and injecting drug use.
The most vulnerable populations include people who inject drugs, men who have sex with men, and prisoners.

Approximately 10 to 20 percent of individuals who are chronically infected with HCV develop complications, such as cirrhosis, liver failure, and hepatocellular carcinoma over a period of 20–30 years.

Direct-acting antiviral therapy is now curative, but it is estimated that only 20 percent of individuals with hepatitis C know their diagnosis, and only 15 percent of those with known hepatitis C have been treated.

Increased diagnosis and linkage to care through access to affordable point-of-care diagnostics and direct-acting antiviral therapy has been identified as essential to achieve the World Health Organisation (WHO) 2030 elimination targets.

But some experts say this may not be achieved without comprehensive access to affordable, feasible, and high-quality diagnostics, to define the epidemic, focus resources, and facilitate pathways for diagnosis and care.

Rapid-detection tests and diagnostics

Advances in rapid diagnostic technologies have created new opportunities for enhancing access to testing and care, as well as monitoring treatment response, several of which were recently reviewed.

These include alternative sampling methods and the combination of rapid diagnostic tests for simultaneous detection of HIV, HBV, and HCV infection.

More affordable options are also being explored for confirmation of active infection such as point-of-care testing and HCV core antigen testing among others.

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Most traditional serological methods for the detection of HBV and HCV are laboratory-based and, although rapid diagnostics tests are available, there is significant variability in their performance as alternatives to laboratory-based tests.

Oral tests for detection of HCV-specific antibodies have slightly lower pooled sensitivity but has comparable specificity compared to blood-based tests, and might be especially useful in contexts in which puncturing may be difficult,

The OraQuick HCV Rapid Antibody Test by OraSure Technologies, US has been one of the best performing and top approved tests by the US Food and Drug Administration (FDA).

However, given the pricing of roughly US$7 per test, it is considered unlikely to be widely adopted in resource-limited settings such as Nigeria, and more affordable tests with comparable performance and accuracy in people with infections.

Two antibody-based rapid detection tests for HBV and two for HCV have received WHO prequalification.

Several tests (CE-mark assays) are commercially available but have not been prequalified.

WHO also has a model Essential Diagnostics List to satisfy the priority healthcare needs of the population.

These are areas investors can look into to offer tests and facilitate mechanisms to improve affordability.

Detection of the virus is important not only for diagnosing active infection but also for screening in blood transfusion services, which is a priority area for scale-up.

Most low-income and middle-income countries use serological assays for blood screening because they are usually simpler and more affordable than molecular testing.

However, these tests often suffer from high rates of false positivity, resulting in unnecessary waste of blood.

As blood safety tests are subject to stricter regulatory requirements compared with diagnostic tests, few options exist for low-income and middle-income countries, and no options are available for point-of-care or emergency settings.

As a result, experts believe the implementation of better quality control and assessment and more feasible product solutions are therefore urgently needed, another opportunity for take-up.

Each year, over 1.1 million lives are claimed globally by hepatitis B + C, the two hepatitis viruses with the biggest public health burden, Lancet said in tweets marking the international day of awareness of the disease.

Hepatitis C is a global health problem that has an estimated 71·1 million individuals struggling with chronic infections from the hepatitis C virus (HCV).

The global incidence of HCV was 23·7 cases per 100 000 population in 2015, with an estimated 1·75 million new HCV infections diagnosed in the same year, a Lancet study shows.

Globally, the most common infections are with HCV genotypes 1, 3, and 4 which constitutes 44 percent of cases, 25 percent, and 15 percent respectively.

According to experts, governments need to place greater focus on national progress towards elimination with support given, if necessary, through innovative financing measures to ensure elimination programmes are fully funded by 2020.

In addition to further measures to improve access to vaccination and treatment, greater attention needs to be paid to access to affordable, high-quality diagnostics if testing is to reach the levels needed to achieve elimination goals.

“We identify key examples of the progress that has already been made in many countries throughout the world, demonstrating that sustained and coordinated efforts can be successful in achieving the WHO elimination goals,” the Lancet Gastroenterology & Hepatology Commission stated in a piece dubbed “Accelerating the elimination of viral hepatitis”.