In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.
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 Hepatitis, 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 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 Jan. 1, 2013, to Dec. 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, Dr. 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 evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
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 wrote.
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, Dr. 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 payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.
“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.
She 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 health care 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.