More work and lower drug prices are needed to eliminate hepatitis C worldwide

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Eliminating hepatitis C virus (HCV) as a global public health concern is feasible, but to do this more people need to be tested and treated and prices of direct-acting antivirals (DAAs) need to come down, according to presentations at the AASLD Liver Meeting last month in Washington, DC.

"We will only eliminate hepatitis C worldwide if we can dramatically increase the number of people cured and lower infection rates," Andrew Hill of the University of Liverpool told aidsmap.com. "At the moment the high prices of treatment are still deterring countries from setting up large scale programs of testing and treatment." 

The World Health Organization (WHO) has set a target of eliminating hepatitis B and C as a public health threat, meaning reducing new HCV and hepatitis B virus (HBV) infections by 90% and reducing deaths due to HCV and HBV by 65% by 2030. To do so, 90% of people living with hepatitis B and C will need to be diagnosed and 80% of eligible individuals will need to be treated.

Glossary

low income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. While the majority of the approximately 30 countries that are ranked as low income are in sub-Saharan Africa, many African countries including Kenya, Nigeria, South Africa and Zambia are in the middle-income brackets. 

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

hepatitis B virus (HBV)

The hepatitis B virus can be spread through sexual contact, sharing of contaminated needles and syringes, needlestick injuries and during childbirth. Hepatitis B infection may be either short-lived and rapidly cleared in less than six months by the immune system (acute infection) or lifelong (chronic). The infection can lead to serious illnesses such as cirrhosis and liver cancer. A vaccine is available to prevent the infection.

cure

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a person’s body, or permanently control the virus and render it unable to cause disease. A ‘sterilising’ cure would completely eliminate the virus. A ‘functional’ cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness. 

direct-acting antiviral (DAA)

Modern drugs for the treatment of hepatitis C, which work directly against the hepatitis C virus. They stop the virus from reproducing by blocking certain steps in its lifecycle.

Currently nine countries – Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar – are on track to eliminate hepatitis C by this date, according to data presented at the World Hepatitis Summit, held last month in São Paulo, Brazil.

Another 22 countries, including the UK, US, Canada and several European countries, are working towards HCV elimination. The remaining 63 countries in the analysis – which include most low-income countries, but also some wealthy ones such as Denmark and Switzerland – will not be able to eliminate hepatitis C by the target date given their present policies.

The data presented by Hill at the Liver Meeting and by Homie Razavi of the Center for Disease Analysis (CDA) at the World Hepatitis Summit come from a database put together by the Polaris Observatory, a CDA project that provides data, tools, and training to support global elimination of hepatitis B and C.

Hepatitis C can only be eliminated if annual cure rates are consistently higher than new HCV infection rates across many countries, according to Hill.

Hill's team compared the net annual change in hepatitis C epidemics in 91 countries between 2016 and 2017, using data on new HCV infections, the number of people treated and cured (assuming a sustained virological response rate of 90%) and deaths of people with HCV.

In the US, for example, there were an estimated 1.40 million diagnosed people (about 51%) and 1.32 million undiagnosed people living with hepatitis C, 30,200 new HCV infections, 110,000 new diagnoses, 208,000 cures and 54,600 deaths in 2016.

While the WHO goal will require that 80% of people with HCV be diagnosed, to date only a handful of countries exceed 70%, including Australia, Canada, France, the Scandinavian countries and Japan. In high-income countries an average of 44% of people with HCV have been diagnosed, falling to 16% in middle-income countries and 9% in low-income countries.

Overall, 1.6 million people were newly infected with HCV worldwide and 1.5 million people were cured last year.

"At the moment, for every person cured of hepatitis C worldwide, another person is infected," Hill told aidsmap.com.

In ten countries (Australia, Canada, Egypt, Iceland, Israel, Japan, Portugal, Qatar, Spain and the US), more than five people were cured of HCV for every new infection in 2016. In contrast, 23 countries had more than five new infections for each person who was cured.

After adding new HCV infections and subtracting cures and deaths, the size of the global hepatitis C epidemic decreased by -1,306,219 people or 2%, from 69.6 million in 2016 to 68.3 million in 2017, Hill reported. Regions with net declines included North Africa and the Middle East (-534,053), Asia and Pacific (-473,520), North America (-243,250), Western Europe (-117,670) and Central and South America (-90,593). Central and Eastern Europe (+166,536) and sub-Saharan Africa (+25,615) had net increases.

A few countries have seen substantial declines in HCV prevalence from 2016 to 2017, including Australia (-13%), Egypt (-11%), the US (-9%) and Spain (-9%). Canada, China and most countries in Western Europe and South America saw declines of -1% to -7%. Russia, India, South Africa and much of the Central Asia had increased prevalence.

Hill emphasised that HCV elimination requires high and sustained rates of both diagnosis and treatment. In most low- and middle-income countries these rates are too low to allow for elimination by 2030.

In addition, some countries that have achieved high rates of hepatitis C treatment (including Brazil, Portugal, and Spain) are starting to run out of diagnosed people to treat and could face what Hill calls "diagnostic burnout" within five to ten years. The phenomenon of "warehousing" patients – or having them delay treatment until better drugs became available – may have already finished in some countries, he suggested.

In contrast, in other countries many people could be diagnosed with HCV but unable to gain access to or afford treatment.

Hill estimated that the actual cost for ingredients and manufacturing to produce a course of DAA treatment could be under US$50, while prices range from $108 in Egypt to $76,757 in the UK to $142,710 in the US. At US$50 per treatment course, it would cost $3.5 billion to treat all 70 million people living with HCV worldwide – around the same as two months' worth of commercial DAA sales.

"The pharmaceutical companies have already profited enormously from their investments in research and development. Now it is time to lower HCV drug prices worldwide," Hill told aidsmap.com. "We need to lower HCV drug prices to levels which allow universal access in a wide range of countries."

As a guide, he suggested that low-income countries should be paying between $50 to $150 per cure, middle-income countries should be paying $150 to $500 and high-income countries should be paying up to $3000.

References

Hill A et al. The road to elimination of Hepatitis C: Analysis of SVR versus new HCV infections in 91 countries. The Liver Meeting, abstract 205, 2017.

View the abstract.

Hill A et al. “Diagnostic burn-out” for hepatitis C: when will countries run out of diagnosed people to treat with DAAs? The Liver Meeting, abstract 975, 2017.

View the abstract.