In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only 1 in 3 US patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention (CDC).
The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.
Lead author Carolyn Wester, MD, with the CDC's Division of Viral Hepatis, called the low numbers "stunning" and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.
The article was published online June 30 in the CDC's Morbidity and Mortality Weekly Report.
Outcomes Vary by Age and Insurance
Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from January 1, 2013, to December 31, 2022.
Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.
Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.
Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.
Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20–39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Wester said. Persistent infection or reinfection was also highest in the 20–39 age group.
With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20–39 age group.
The investigators only evaluated people who had been diagnosed with HCV, Wester said. "It's estimated about 40% of people in the US are unaware of their infection." Because of this, the numbers reported in the study may vastly underestimate the true picture, she told Medscape Medical News.
Barriers to Treatment "Insurmountable" Without Major Transformation
Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors write.
The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Wester added.
Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payor, and prevention services for persons at risk for acquiring new HCV infection, the authors conclude.
"The current barriers are insurmountable without a major transformation in our nation's response," Wester noted.
Wester expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration's 2024 budget proposal. She said that the initiative "is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of healthcare dollars."
The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.
Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
What Can Physicians Do?
Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Wester said.
Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.
Recommendations include curative treatment "for nearly everybody who is living with hepatitis C," Wester added.
These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, Wester noted.
Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Wester said.
Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Wester said.
Prior Authorization a Problem
Stacey Trooskin MD, PhD, MPH, assistant professor of medicine at the Perelman School of Medicine in Philadelphia, Pennsylvania, told Medscape Medical News that prior authorization has been a major barrier for obtaining medications. Prior authorization requrements differ by state.
The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the healthcare system may be lost, said Trooskin, who is chief medical adviser to the National Viral Hepatitis Roundtable.
"We know that about half of all Medicaid programs have removed prior authorization for most patients entirely," she said, "but there are still half that require prior authorization."
Action at the federal level is also needed, Trooskin said.
The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.
Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.
"It's not enough to want patients to come into their primary care provider and for that primary care provider to screen them," Trooskin said. "This is about creating healthcare infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing."
Co-author Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Co-author William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.
MMWR Morb Mortal Wkly Rep. 2023;72:716–720. Full text
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.
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Cite this: A Decade After First DAA, Only 1 in 3 Are HCV Free - Medscape - Jul 11, 2023.