AASLD 2017: More Work and Lower Drug Prices 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 so more people need to be tested and treated, and prices of direct-acting antivirals 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," said Andrew Hill of the University of Liverpool. "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.

Currently 9 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 monthin São Paulo, Brazil.

Another 22 countries, including the U.S., Canada, U.K., 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 U.S., 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 said.

In 10 countries (the U.S., Australia, Canada, Egypt, Iceland, Israel, Japan, Portugal, Qatar, and Spain), more than 5 people were cured of HCV for every new infection in 2016. In contrast, 23 countries had more than 5 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, according to Hill.

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 U.S. (-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 emphasized 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 5 to 10 years. The phenomenon of "warehousing" patients -- or having them delay treatment until better drugs became available -- may have already finished in some countries, Hill suggested.

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

Hill estimated that the actual cost for ingredients and manufacturing to produce a course of direct-acting antiviral treatment could be under $50, while prices range from $108 in Egypt to $76,757 in the U.K. to $142,710 in the U.S. At $50 per treatment course, it would cost $3.5 billion to treat all 70 million people living with HCV worldwide -- around the same as 2 months worth of commercial DAA sales, he said

"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 said. "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.

11/30/17

Sources

A Hill, S Nath, and B Simmons. The road to elimination of Hepatitis C: Analysis of SVR versus new HCV infections in 91 countries. AASLD: The Liver Meeting. Washington, DC, October 20-24, 2017. Abstract 205.

A Hill, A Kahn, S Nath et al. "Diagnostic Burn-out" for Hepatitis C: when will countries run out of diagnosed people to treat with DAAs? AASLD: The Liver Meeting. Washington, DC, October 20-24, 2017. Abstract975.