National Academies: How to Eliminate Hep B, C in US by 2030

Alicia Ault

March 28, 2017

To put an end to hepatitis B and C in the United States, needle exchange programs should be expanded, hepatitis B virus (HBV) vaccines should be provided for free, and the federal government should buy a limited license to one of the existing hepatitis C virus (HCV) antivirals so that the expensive treatment can be given to more individuals in prison and on Medicaid.

In addition, primary care physicians need to take a greater role in treating patients with HBV and HCV. That's the conclusion of a National Academies of Sciences, Engineering, and Medicine (NAS) committee, which has just issued A National Strategy for the Elimination of Hepatitis B and C . It is the panel's second and final report on the effort to purge the viral scourges from the United States by 2030. The report is the US response to a World Hepatitis Alliance challenge issued in 2016.

"Viral hepatitis is simply not a sufficient priority in the United States," said Brian Strom, MD, chair of the committee and chancellor and university professor, Rutgers Biomedical and Sciences, Rutgers University, Newark, New Jersey. "Despite being the seventh leading cause of death in the world – and killing more people every year than HIV, road traffic accidents, or diabetes – viral hepatitis accounts for less than 1% of the National Institutes of Health research budget."

More than a million Americans have chronic hepatitis B infection, and almost 3 million have chronic hepatitis C. HBV- and HCV-related diseases kill about 20,000 people a year in the United States. Dr Strom said in a briefing with reporters that the two viruses cause 80% of liver cancers globally and were the primary cause of an almost 40% increase in liver cancer in the United States from 2003 to 2012.

HBV can be prevented with vaccination. Some 60,000 deaths from HBV-related disease could be eliminated if 90% of the patients with chronic infection were diagnosed and brought to care and if 80% were treated, said the committee.

Atlhough the United States has done a decent job vaccinating children — with 90% coverage ― only about 25% of adults older than 19 years have been vaccinated. The committee urged states to remove barriers to offering hepatitis B vaccine in pharmacies, saying that could help reach a wider swath of the US population.

HCV can be cured with antivirals, although treatment is underutilized because of its expense ― $80,000 to $90,000 per course of therapy ― said the NAS committee. Even with that cost, "its efficacy is so high that when you look at its benefit compared to its cost, it's actually quite reasonable compared to the rest of what we do in medicine," said Dr Strom.

License a Hep C Treatment?

The panel came up with what it believes is a novel solution to ensuring that more Americans are treated with HCV antivirals: ask the manufacturers to bid on giving the federal government a limited license to sell one or more of their products.

No direct-acting antiviral comes off patent until 2029, which means the cost of those products will continue to delay treatment for many individuals who need to be targeted to stop the spread of the disease, said the panel. The delay will lead to billions of dollars in medical costs, and lost lives.

If nothing changes, the federal government will spend $10 billion over the next decade to treat just 20,000 people on Medicaid and in prisons. Each of the antiviral manufacturers will sell some $2 billion worth of product during the same period.

If the government offered an up-front licensing payment of $2 billion to one company to sell its product to vulnerable populations, "it's a great deal for the company," said panel member Neeraj Sood, PhD, vice dean for research at the Schaeffer Center and professor at the Sol Price School of Public Policy, University of Southern California, Los Angeles.

This type of thing has not been done before, but it is legal, said Dr Sood.

Dr Strom portrayed it as a "win-win." Drug makers would get "access to markets they are selling very little in right now." The federal government would spend $2 billion instead of $10 billion, and more patients would receive treatment.

The NAS committee determined that a total of 260,000 Americans need to be treated annually to achieve a 90% reduction in HCV incidence by 2030. To reach that goal, the panel also recommended finding ways to increase needle exchange and access to opioid agonist therapy, because injection drug users account for 75% of new HCV infections.

Top-Level Coordination Required

The panel said that a high-level — possibly White House–level — commission should be created to coordinate an effort to eliminate viral hepatitis.

It also urged the US Centers for Disease Control and Prevention to work with states to identify settings for greater screening for both HCV and HBV. It called on the criminal justice system to screen incarcerated individuals, to offer treatment to those who test positive, and to vaccinate those who had not previously been vaccinated.

To get more services to patients — especially the more vulnerable ― the federal government should find a way to build a comprehensive program such as that created by the Ryan White Act for the uninsured and underinsured with HIV. Under Ryan White, state and local health departments use federal grants to offer HIV care and support services, such as case management and transportation. "A system of the same flexibility and breadth would be needed to reach the marginalized populations suffering from viral hepatitis," said the panel in its report.

Bringing Primary Care Into the Mix

Expanding diagnosis and treatment of hepatitis will mean bringing more physicians into the mix, said the panel. It recommended that the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America partner with primary care providers and their professional organizations to increase capacity to treat hepatitis B and C in primary care.

Viral hepatitis does not necessarily mean complications, said the panel.

Only 20% to 25% of patients with chronic hepatitis C infection will develop cirrhosis after 2 or 3 decades, and more than half of all patients with chronic hepatitis B will never develop any life-threatening complications. But for patients who do develop those complications, management can be more difficult — which is why many physicians, especially those in small and rural practices, do not have the inclination or resources to care for those patients.

Models such as the University of New Mexico's ECHO program could help primary care practices manage HBV and HCV patients, said the panel.

It also recommended that any program for viral hepatitis establish referral systems for medically complex patients.

The study was sponsored by the Division of Viral Hepatitis and the Division of Cancer Prevention and Control of the Centers for Disease Control and Prevention; the US Department of Health and Human Services Office of Minority Health; the American Association for the Study of Liver Diseases; the Infectious Diseases Society of America; and the National Viral Hepatitis Roundtable.

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