The Challenge of Eliminating Hepatitis C Virus in the United States

A mini-symposium held on October 8, 2017, at ID Week 2017 in San Diego, California addressed the challenges faced in eradicating hepatitis C virus (HCV) infections globally, with 2 speakers focusing on the considerable challenges faced domestically. Both agreed that, while daunting, the World Health Organization (WHO) timeline can be met, with federal government buy-in, ongoing vigor in identifying people who are infected with the virus, and with the revamping of the drug licensing process to encourage the availability of the needed medications for those who are not on the usual radar of companies.

In May 2016, WHO published a report outlining a timeline to achieve the global elimination of HCV by 2030. This ambitious goal demands heavy-lifting from the global community, including the United States.

As a first response, the National Academies of Sciences, Engineering, and Medicine (NASEM) authored a report released about 6 months ago that outlined the recommendations to eliminate HCV in the United States by 2030. Shruti Mehta, PhD, MPH, Johns Hopkins Bloomberg School of Medicine, Johns Hopkins University, Baltimore, Maryland, who was one of the authors of the report, offered her perspectives on the issue.

“The NASEM recommends a 90% reduction in the incidence of hepatitis C by 2030, relative to 2015. This represents a reduction from 35,000 to 2730 cases per year. What is needed to achieve this? Aggressive treatment, with the treatment of everyone, regardless of their disease stage, and aggressive case finding and diagnosis, with 110,000 cases per year through 2020, 89,000 cases per year from 2020 to 2024, and 70,000 cases per year from 2025 to 2030,” she said.

Diagnosis and cure must keep the same pace with time, even as the cases become more challenging to identify as the prevalence of the disease declines and the infected become less visible. Concurrently, prevention efforts need to be in place. It’s a huge challenge. But, there’s a huge payoff. “The same levels of diagnosis and treatment would reduce mortality from hepatitis C in 2030 by 65 percent relative to 2015, and avert 28,800 deaths in the United States by 2030,” said Dr. Mehta.

This is not something that can be achieved at a local or state level. The highest level of the federal government needs to coordinate the elimination effort. “Elimination will require coordinated action from various federal and state government agencies, high political support, and financial support. The leadership of a single office would help ensure efficient and harmonious work,” said Dr. Mehta.

The Centers for Disease Control and Prevention (CDC) need to be a leader in monitoring the prevalence of HCV and hepatitis B virus (HBV). Reliable data on new infections, morbidity, and mortality are a critical component of tailoring the response. Not all state/local health departments have sufficient resources. As well, CDC needs to support studies geared towards clarifying the prevalence of the disease. Surveillance alone, such as through national surveys like the National Health and Nutrition Examination Survey (NHANES), will not be sufficient. One suggestion from the NASEM report is to integrate HCV antibody and RNA testing into existing serosurveys, including in incarcerated individuals.

Another absolute “must” is intervention in the form of expanded access to syringe exchange and opioid agonist therapy. The recent upsurge in the prevalence of HCV has been driven in large part by people who live in rural settings without ready access to syringe exchange facilities and walk-in medical assistance. Part of the expanded access is the recommended removal of restrictions in current public and private health plans that are not medically indicated and the availability of directing-acting antivirals to all chronic HCV infected person. “There have been multiple demonstrations that treating regardless of disease stage is cost-effective,” noted Dr. Mehta.

Another recommendation is the expansion of screening and treatment to settings that high-risk patients are likely to use, such as the emergency room. Ideally, access would be universal and include the public healthcare setting. Instead of waiting for someone to seek treatment, treatment would be available through local clinics. Restrictions on prescription approval should also be removed, as has been advocated by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.

Incarcerated individuals are another essential population to address. The prevalence of HCV is high in these individuals and over 90% will ultimately be released from prison. Thus, all those who are incarcerated should be able to receive screening, vaccination, and treatment. The success of this approach, as well as assistance offered through Medicaid and to Native people, will require creative financing to ensure maximum availability of the drugs. The NASEM report committee feels this could be achieved by a novel licensing arrangement or patent assignment to innovative pharmaceutical companies.

The CDC is on-board in the elimination efforts. John Ward, MD, Division of Viral Hepatitis at CDC and the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Atlanta, Georgia, discussed their role.

The CDC is already committed to the elimination of HCV in US veterans. About 80% of Veterans born between 1945 and 1965 have been screened, with over 90% diagnosed and almost all of those having been treated (and almost always cured). About 58,000 remain eligible for treatment and are proving to be challenging to track down.

Another program involving the Cherokee Nation is underway, with 46% of the target population having been screened. As with Veterans, those who receive treatment are cured. A program to deliver HCV testing through primary care to people who are homeless or in public housing in Philadelphia has worked and will hopefully be rolled out nationwide. Correctional facilities are “the biggest challenge” according to Dr. Ward. He points to ongoing class action lawsuits in 10 states initiated by prisoners as a potential means of enacting legislative change that will drive the expansion of HCV screening and treatment to include correctional facilities.

Cognizant of the upsurge in HCV cases in suburban and rural settings, the CDC is committed to expanding testing outside of urban centers beginning in 2018, and in strengthening their surveillance capacity in national hotspots of HCV and HBV infection. The agency has also embraced new technology, such as next-generation sequencing, and the use of cloud computing as a repository of data. The GHOST cloud-based tool is in use or soon will be in use by 22 states.

Studies have shown that, when it comes to syringe exchange and opioid agonist therapy, availability leads to use—the ‘if you build it, they will come’ approach. CDC is fully on-board with expanding the syringe exchange network and is financially committed to these services as an “expected and funded public health service.”

The hopeful outcome, according to Dr. Ward, will be a healthier nation and the ultimate elimination of HCV by 2030.

In 2013, viral hepatitis was a leading cause of death worldwide, with a death toll of nearly 1.5 million people. This is greater than the deaths due to HIV, tuberculosis, or malaria. Hepatitis-related death has been increasing for a quarter-century, with over 90% of the deaths due to infection by HCV or hepatitis B virus.

Prevention can reduce the rate of new infections, but the number of those already infected would remain high for a generation. In the absence of additional efforts, 19 million hepatitis-related deaths are anticipated from 2015 to 2030.

DISCLOSURES

Shruti Mehta: none

John Ward: none

PRESENTATION

Mini-Symposium: Global Elimination of Hep C

Report of the NAM on HCV Elimination in North America

Shruti Mehta, PhD, MPH, Johns Hopkins Bloomberg School of Medicine, Johns Hopkins University, Baltimore, MD

Plan for Implementation of Hepatitis C Elimination

John Ward, MD, Division of Viral Hepatitis, Centers for Disease Control and Prevention/NCHHSTP, Atlanta, GA

Brian Hoyle, PhD, is a medical and science writer and editor from Halifax, Nova Scotia, Canada. He has been a full-time freelance writer/editor for over 15 years. Prior to that, he was a research microbiologist and lab manager of a provincial government water testing lab. He can be reached at hoyle@square-rainbow.com.