New data released at this year's World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) show that out of an estimated 2.7 million1 people now living with hepatitis C in the US, only just over half (55%) are aware, contributing to increasing infection rates and poor treatment outcomes. This means that the US is very unlikely to meet either the WHO hepatitis elimination target* or its own national targets set out in the National Viral Hepatitis Action Plan 2017-2020.2
Hepatitis C is a 'silent killer', accounting for around 23,000 deaths across the US in 2016, a figure that is rising each year. In 2007, mortality related to hepatitis C surpassed that of HIV in the US; and since 2012, hepatitis C-related deaths have surpassed deaths from all the other 60 nationally reportable infectious diseases combined. Only half of people living with the disease are aware of their condition, largely due to the disease being mostly asymptomatic and the lack of routine screening. The result for many is a missed opportunity to access the highly effective cures that can stop them succumbing to liver disease, cirrhosis and liver cancer and can cure them of the virus entirely.
Risk factors for hepatitis C infection include injection drug use past or present, including steroids, medical or dental procedures abroad, unsterile tattoos and piercings, and blood transfusions for any reason before 1992 when the US began screening all donated blood for hepatitis C.
These latest data from The Polaris Observatory, Center for Disease Analysis Foundation, Lafayette, CO, USA (led by Dr Homie Razavi and his team) reveal that, like other high-income countries, the USA is facing a problem with diagnosis, although state level data from the six states for which Polaris has data show that diagnosis rates are above the national estimate of 55%: Rhode Island (60%); Ohio (61%); Louisiana (64%); California (71%); Washington (76%) and New York (81%). However, even these are not high enough to enable enough patients to enter treatment.
"Despite the different levels of diagnosis across the US, there are also problems linking people to care," said Dr Homie Razavi. "The fact is that even when people are diagnosed, they are not being referred and often don't get treated," adding that "there are many possible reasons for patients not accessing treatment."
Among these reasons are that, in two thirds of states3, treatment on Medicaid programs has been restricted to people with advanced disease, preventing treatment access for those without private insurance. Some patients (and doctors) may not view treatment as a priority due to lack of symptoms and disease progression. Some people may not be aware of the short and generally side effect-free treatment (direct acting antivirals [DAAs]) now available. And others may be lost in the system or out of reach of care providers, including injection drug users.
In 2015, the USA treated around 256,000 patients and some 230,000 in 2016. Polaris's latest projections suggest that without new initiatives to boost treatment and diagnosis rates the annual number treated across the USA will fall to just 130,000 per year by 2020. To reach the WHO 2030 elimination target, treatment levels must be sustained at 250,000 per year leading up to 2030. The USA is also unlikely to meet the targets set out in its own national plan, some of which are even more ambitious - such as a 60% fall in both hepatitis B and hepatitis C new infections by 2020.
Another issue facing the USA is the explosion of new infections faced by certain states caused by the opioid crisis, with steep increases in young white men and women in certain urban areas. As a result, the CDC reports a 250% increase in new HCV cases from 2011-2014, and reported infections are now at a 15-year high. However, most people do not know they are infected and thus many new infections go unreported. The new data from Polaris suggests almost 38,000 people contracted hepatitis C in 2016 alone. All states are at risk in the opioid crisis, which has just been declared a national public health emergency by US President Donald Trump.
"Policymakers are starkly aware of the heroin-fentanyl epidemic sweeping America," said Michael Ninburg, President Elect of the World Hepatitis Alliance. "They also need to be aware of the resulting ballooning hepatitis C infections in certain states, most notably amongst young adults and adolescents, and be proactive about diagnosing and treating those in need."
Across the USA, certain populations continue to face an enormous struggle to access hepatitis C drugs, including prisoners and people who inject drugs. An estimated 1 in 6 prisoners has HCV, but access to new treatments is severely restricted by prison budgets. And although some critics may argue that people who inject drugs may not be suitable for hepatitis C treatment that requires a daily pill, recent studies3 have reported cure rates equal to those in other people with HCV. Thus the central issue for people who inject drugs is to be diagnosed and start treatment, not whether or not treatment works.
However, the outlook is not entirely bleak -- recent developments have meant the approval of new and cheaper hepatitis C drugs, which can be used to treat all types of the virus (genotypes 1-6), requiring just 8 weeks of treatment to achieve cure. At $26,400 per course, this combination of 2 drugs glecaprevir and pibrentasvir (made by AbbVie) is cheaper than courses of similar hepatitis C medications ($55,000-95,000).
These lower prices are allowing states such as Delaware, that previously restricted treatment to the sickest patients, to open up Medicaid coverage to all hepatitis C patients from January 2018. Delaware joins 16 other states (including Alaska and Georgia) that will open up restrictions (or never had them). At the recent Liver Meeting in Washington, DC (October 28) all states and Puerto Rico were graded on how easy it is to obtain Medicaid treatment for hepatitis C. States receiving the best grade of A were Alaska, Connecticut, Massachusetts, Nevada, and Washington. States that received an "F", the worst grade, were Arkansas, Louisiana, Montana, Oregon, and South Dakota.4
For patients with private insurance, it has generally (but not always) been much easier to obtain hepatitis C treatment. However, as many of these patients may have already accessed care and been cured, the pool of patients to treat is rapidly declining.
Similarly, at a state level, various initiatives are ongoing to boost diagnosis rates. In New York State, a 2014 law required primary care providers to test all people born 1945-1965 for hepatitis C. This increased the number of tests in this age group from 538,229 in 2013 to 813,492 in 2014, a 51% rise. The proportion of newly diagnosed patients who were then linked to care also increased by a third state-wide.
In Chicago, USA, Mount Sinai Hospital automatically tested anyone over 16 needing blood tests in the emergency room for 6 months, resulting in 200 new diagnoses. Emergency room screening is also helping detect some 70% of new cases in the Cherokee Nation in Oklahoma, which has its own hepatitis C elimination plan. All patients visiting the doctor or the dentist are also offered a test for hepatitis C.
Ninburg concludes: "We have the tools to eliminate hepatitis C in the US. We have effective cures for hepatitis C, and also effective vaccination to prevent hepatitis B. Now we just have to make ending hepatitis a political priority and prevent hundreds of thousands of needlessly premature deaths."
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Notes to editors:
1 2.7 million is the latest estimate of total chronic HCV cases requiring treatment in 2016 across the whole of the USA, produced by the Polaris Observatory, continuing on from their 2015 estimate. The Polaris Observatory is the source used by WHO for regional and global estimates on hepatitis C, based on the latest modelling and data available. Although this is considerably lower than the US CDC estimate of 3.5 million in 2010 (source Edlin 2015), the new Polaris estimate also incorporates the changing population after 2010 due to deaths*, new infections*, and cure (an estimated 684,000 cured from 2010-2016, based on treatment data from IMS Health and standard SVR rates).
For USA data and projections, see: http://tonykirby.com/hepatitis/PolarisDataUSA2017.xlsm
2 For details of the US National Viral Hepatitis Action Plan 2017-2020, see: https://www.hhs.gov/hepatitis/action-plan/u-s-viral-hepatitis-action-plan-overview/index.html
3 the PREVAIL sand SIMPLIFY studies have been recently presented at scientific meetings and are due for publication. Both show cure rates above in injectiob drugs users of 90-95%, similar to those in other persons with HCV.
4 the latest Medicaid report card, released at the Liver Meeting in Washington, DC, on Monday October 23, shows the latest situation regarding treatment restrictions in all states. Please see: https://stateofhepc.org/report/