‘We need your help’: AASLD support, outreach key to success of HCV elimination program

WASHINGTON — An expert panel of physicians, researchers and scientific advisers called upon The Liver Meeting attendees to support a proposed national HCV elimination program in the US.

“We don’t get to use the word ‘eliminate’ all that often with a disease that is taking thousands or tens of thousands or, worldwide, hundreds of thousands of lives every year,” Francis S. Collins, MD, PhD, former director of NIH and acting science adviser for President Joe Biden, said. “But we have that opportunity with hepatitis C.”

Collins outlined the current state of HCV infection in the United States, citing recent data from the CDC that show significant increases in new, acute cases of HCV in young adults and IV drug users. “Around 2.4 million people are living with HCV in the United States, 40% of whom are unaware of their infection despite the fact that routine and broad screening has been recommended for everybody over 18,” Collins said. “Our goal is to try to do something to change this, because we now have highly effective oral agents that don’t just treat the disease, they cure it 95% to 97% of the time.”

Despite the widespread availability of testing and curative therapy, Collins explained that a substantial gap exists between diagnosing and treating the disease, driven largely by a lack of awareness, a “clunky” two-step diagnostic process and the expense of treatment, which can reach nearly $90,000 per patient for direct-acting antivirals.

“Let’s be clear,” he said. “You’re dealing with hard-to-reach populations that are underserved, uninsured, people who are in tough times, justice-involved populations, and anything you put in the way as a barrier is going to make this worse.”

He continued, “If we are a country that cares about all its people, a country with a lot of resources, and a country that’s able to think about cost and benefit, this ought to be a case where we can jointly put together a plan — a national plan — to eliminate this disease.”

Next Steps toward Elimination

Rachael Fleurence, PhD, MSc, serving in the White House Office of Science Technology Policy, detailed the renewed focus of the national plan, following discussions with federal agencies, patient and advocacy groups, manufacturers, insurers and state leaders.

“A large component and a large focus will be working on diagnostic test development, but also accelerating and bringing into the U.S. tests that are currently available outside of the U.S.,” Fleurence said. “These include point-of-care RNA diagnostic tests, as well as core antigen laboratory tests.”

The program also would implement a national subscription model that would make DAAs available to Medicaid beneficiaries, justice-involved populations, uninsured individuals, and American Indian and Alaskan natives who are receiving care through the Indian Health Service. It also involves working with commercial insurers to potentially offer copay assistance for Medicare beneficiaries and decrease barriers to access.

Further, a public health information effort will entail “substantially expanding screening strategies, especially for high-risk populations,” Fleurence said, as well as increasing the number of providers that can screen and treat HCV with telemedicine, ensuring the right incentives are set in place for providers, increasing the linkage of care and the number of community health workers, and supporting vaccine research and development, as well preventive services.

Fleurence noted that the next steps for this program include obtaining funding to support the NIH Radx program to accelerate diagnostic testing and supporting pilot trials conducted by the CDC, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration and Indian Health Service.

Call to Action

Although Collins praised the creation of this program, which he called “one of the more exciting, positive developments of the last 20 years,” he acknowledged that still more needs to be done.

“We need your help,” he implored attendees at The Liver Meeting. “This is a bold initiative. But it’s an opportunity. It’s even a responsibility. If we can succeed at this kind of outreach and save lives and at the same time save money, how can we not do that?”

He emphasized the need for strong partnerships and collaborations, and explained that it is not enough to have more drugs and tests available.

“We’re going to have to work hard on the delivery systems, about how we get these kinds of drugs into populations that are not traditionally easy to reach and working with physicians who are not comfortable with that kind of outreach,” he said.

Collins further stressed the importance of communication and outreach between specialty physicians, primary care providers, community health centers and prison personnel in realizing this vision. “We’re hoping we can count on the experts in AASLD to be our advisers in this regard,” he continued, “and ask you all to reach out in ways that maybe you might not have otherwise done to try to support this program once it gets underway across the country.”

‘Beacon of Hope’

To develop the strongest resources, plans and policies to eliminate HCV, the health care community must first address stigma, racism and discrimination associated with disease, Adrienne Simmons, PharmD, MS, director of programs at the National Viral Hepatitis Roundtable, told attendees. “We’ve seen firsthand the impact that structural barriers have on equitable access to care,” she said. “We often hear about communities that are hard to reach, but the reality is that our health care system is hard to reach.”

According to Simmons, notable barriers to care include the need for multiple appointments with specialists, the inability to access treatment while incarcerated and the paperwork required for insurance to approve treatment. “This plan will only be successful,” she said, “with strong leadership and strategies aimed at eliminating as many structural barriers as possible, including resources and infrastructure for harm reduction, testing and linkage to care.”

Simmons encouraged the AASLD community to imagine a world that is better than the one we live in today — and asked that everyone embrace their role in making that goal a reality.

“This is a historic moment for the hepatitis C community — for patients, loved ones, providers, advocates, researchers, community-based organizations and government partners who have worked tirelessly to lessen the impact of this public health crisis,” she said. “For many, the prospect of a national program is a beacon of hope that follows decades of lives lost to a preventable — and now curable — disease.”