Eliminating hepatitis C as a public health concern in the United States and worldwide is feasible, but only if more people can be diagnosed and treated.
Currently nine countries are on the path to hepatitis C virus (HCV) elimination, but the United States is not among them, researchers reported at the recent Liver Meeting, the annual conference of the American Association for the Study of Liver Diseases (AASLD), and at the World Hepatitis Summit in São Paulo, Brazil.
“At the moment, for every person cured of hepatitis C worldwide, another person is infected,” Andrew Hill, MD, of the University of Liverpool, told MedPage Today.
“We will only eliminate hepatitis C worldwide if we can dramatically increase the number of people cured and lower infection rates,” Hill added. “We estimate that at least five million people will need to be diagnosed and cured every year to achieve WHO targets for elimination of HCV by 2030.”
In 2016 the World Health Organization set the ambitious goal of reducing new HCV and hepatitis B virus (HBV) infections by 90% and reducing deaths due to these infections by 65% before 2030. WHO estimates that approximately 71 million people worldwide have hepatitis C, of whom about 20% know they are infected, and around 257 million have chronic hepatitis B, of whom only 10% know their status.
The advent of direct-acting antiviral agents (DAAs) for hepatitis C treatment is widely regarded as one of the major achievements of modern medicine. But to date only a small proportion of the population thought to be infected with HCV is benefiting from these advances.
New data from the Polaris Observatory, a project of the Center for Disease Analysis (CDA), show that nine countries (Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar) are on track to eliminate hepatitis C by 2030, CDA director Home Razavi, PhD, reported at the World Hepatitis Summit.
“What we are seeing is that some countries, especially those with a high burden, are making the elimination of viral hepatitis a priority and are looking at innovative ways to do it. However, it will be near impossible for most other countries to meet the WHO targets without a huge scale-up in political will and access to diagnostics and treatment,” Razavi said in a World Hepatitis Alliance (WHA) press release.
For example, Egypt — which has one of the highest HCV prevalence rates in the world — has implemented an aggressive population screening program and is mass producing generic DAAs for less than $200 for a 12-week treatment course.
Australia has reached agreements with pharmaceutical companies to provide government-funded treatment at a discounted price for all hepatitis C patients without restrictions. More than 32,000 people — around 14% of those infected — were treated and cured in 2016. Yet while treatment scaled up rapidly in early 2016, the pace has since slowed.
In Australia and other high-income countries, data suggest that people who were already diagnosed and awaiting the arrival of better treatment options — a phenomenon dubbed “warehousing” — have now mostly been successfully treated.
Thus, some countries will run out of patients to treat unless more people can be screened and diagnosed — a status Hill calls “diagnostic burnout.”
According to Razavi’s data, new hepatitis C diagnoses must triple from 1.5 million to 4.5 million annually and treatment rates must increase from 1.8 million to 5.0 million in order to achieve WHO’s elimination targets by 2030.
“Only with a combination of political will, increased access to diagnostics, and greater awareness of the disease can we vastly improve diagnosis rates. Unless we crack this diagnosis challenge, the ambitious elimination targets for hepatitis set by WHO will remain out of reach for decades to come,” Razavi said in another WHA press release.
Not only have a majority of people with hepatitis C never been diagnosed, but many of those who were diagnosed years or decades ago were never treated due to the suboptimal efficacy and other drawbacks of interferon, and they may be unaware that better options are now available.
Using the Polaris data, Hill and colleagues calculated the change in the size of the global hepatitis C epidemic, based on expected rates of sustained virological response to treatment, new HCV infections, and deaths.
In 2016 there were around 69.6 million people living with hepatitis C worldwide, Hill reported at the Liver Meeting. Since then there have been around 1.6 million new HCV infections, around 1.5 million cures, and around 1.4 million deaths of people with HCV, leaving 68.3 million people with hepatitis C in 2017.
This 2% reduction is not large enough to reach the WHO target for hepatitis C elimination, Hill said. In 10 countries more than five people were cured for each person newly infected in 2016, but in 23 countries there were more than five new infections for each person cured.
The cost of DAAs has been a major barrier to wider treatment at the global level, although prices have come down thanks to negotiated discounts and increased market competition. But the cost will have to drop further in order to treat enough people to eliminate HCV, according to Hill.
He said that using a sliding scale based on a country’s ability to pay, low-income countries should be paying between $50 and $150 per cure, middle-income countries between $150 and $500, and high-income countries up to $3,000. At $50 per course, it would cost about $3.5 billion to treat all people with hepatitis C worldwide.
“A cure for hepatitis C can be manufactured for $50, but these same treatments are being sold for over $10,000 in many countries. We need to lower HCV drug prices to levels that allow universal access in a wide range of countries. At the moment the high prices of treatment are still deterring countries from setting up large-scale programs of testing and treatment,” Hill told MedPage Today.
HCV Elimination in the U.S.
In the United States only 55% of the estimated 2.7 million people living with hepatitis C are aware of their status, according to the Polaris data, suggesting that the country is unlikely to reach either the WHO goal or the targets in the National Viral Hepatitis Action Plan. Around 256,000 patients were treated in 2015 and around 230,000 in 2016, but without new efforts to increase diagnosis and treatment rates, those numbers are projected to fall.
Government officials, public health experts, and researchers discussed the prospects of hepatitis B and C elimination at a Liver Meeting session sponsored by the CDC.
“I wish I could say we’re on the cusp of HCV and HBV elimination, but the data don’t support that optimism,” said Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “However, I do think the arc of the viral hepatitis epidemics in the country bend towards elimination … we have the tools and we have the knowledge to reverse what are some of the worse epidemics in recorded history.”
Mermin, Wilson Compton, MD, of the National Institute on Drug Abuse, and U.S. Surgeon General Jerome Adams, MD, all emphasized the link between the ongoing opioid epidemic and rising rates of hepatitis C, which is moving beyond its traditional baby boomer demographic and increasingly affecting young adults and their children.
“The hepatitis C and opioid epidemics are intricately linked, and we’re only going to solve them together,” Adams said.
Ryan Clary, executive director of the National Viral Hepatitis Roundtable, presented a report on the status of Medicaid coverage of HCV treatment, showing that while access has improved since 2014, there are still 12 states that cover treatment only for people with advanced liver fibrosis, 20 states that require at least 6 months of abstinence from drug or alcohol use, and nine states that only cover treatment prescribed by a liver specialist, even though studies show that primary care physicians can successfully treat HCV.
“It is disturbing to learn that not only is the U.S. not on track with elimination goals, but it lacks the leadership needed to identify people with hepatitis C and link them to care and treatment,” Clary told MedPage Today. “People with hepatitis C and their advocates must demand that the U.S. government change course and lead a coordinated, well-funded effort to prevent new infections, save lives, and eliminate hepatitis C for good.”