Two-Thirds of Americans with Hepatitis C Have not Cleared Disease

Carolyn Wester, MD

Credit: CDC

Just one-third of US patients diagnosed with hepatitis C virus (HCV) achieved disease clearance or curation in the last decade, according to new Centers for Disease Control (CDC) data.¹

A new longitudinal data analysis from a team of CDC investigators showed the country is significantly behind its Viral Hepatitis National Strategic Plan goal for ≥80% HCV clearance in the affected patient population by 2030. The findings come despite a robust and widely available class of oral direct-acting antiviral (DAA) regimens being associated with a ≥95% curative rate in treated patients; the investigators believe there remain significant gaps in patient access to diagnostic, therapeutic and preventive resources for their HCV.

Led by Carolyn Wester, MD, of the division of viral hepatitis at the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, investigators sought to provide a national report of HCV clearance cascade rates during “the DAA era,” defined as 2012 – 2022 in relation to the drug class’s initial availability on the US market. A 5-step clearance cascade, tracked via national laboratory results, was guided by the CDC to help track the progression of patients from initial diagnosis, to eventual treatment, and hopeful disease clearance.

“Characterizing the HCV clearance cascade is critical for monitoring progress toward national elimination goals, identifying gaps in care and program effectiveness, and prioritizing public health resource allocations,” Wester and colleagues wrote. “Previous HCV care cascades have required using data from a variety of sources (e.g., household surveys, cohort studies, laboratory testing, and pharmacy claims) to inform distinct steps in the cascade.”

The team used data from patients living in all 50 US states and the District of Columbia who received HCV testing results via Quest Diagnostics. The 5-step cascade was characterized as these stages of disease:

1. Ever infected, per positive HCV test result
2. Viral testing for a person having ever been infected
3. Initial infection
4. Cured or cleared
5. Persistent infection or reinfection

Investigators reported the frequency of persons at each step of the cascade, with conditional proportions calculated by the number of persons identified meeting the step, divided by the number of people identified meeting the previous step of the cascade. They additionally assessed proportions of each step based on patient age, sex and payor type.

The final analysis included 1.7 million persons having ever been infected with HCV. Patients were primarily 40 – 59 years old (43%) and 60% were male. Approximately half were covered by commercial health insurance; 19% received either Medicaid or Medicare.

Among the cohort, approximately 1.5 million (88%) had received viral testing. Just more than 1 million (69%) of those patients with viral testing were categorized as having an initial infection. Of the initially infected patients, 356,807 (34%) were cured or cleared of HCV. Of the cured and cleared population, 23,518 (7%) had a persistent infection or reinfection.

Investigators noted that initial HCV infection rates was lowest among those aged 0 – 19 years old (41%). Just 63% of patients with commercial insurance reported initial infection. Only one-fourth (24%) of patients aged 20 – 29 years old had achieved clearance or cured disease. Additionally, 45% of patients receiving Medicare achieved cleared or cured disease.

The team noted their findings were consistent with recently published HCV treatment coverage data among insured adults that showed a similarly “large gap between current viral clearance and the nation’s goal of ≥80% viral clearance” by 2030.

In a recent interview with HCPLive, Kris V. Kowdley, director of the Liver Institute Northwest and professor of medicine at Elson S. Floyd College of Medicine at Washington State University, said that a major hurdle impeding the 2030 HCV clearance goal is the opioid epidemic—wherein approximately 1 in 3 patients injecting drugs are developing the virus.

“I think we have to recognize that if we don’t treat that population, we’re not going to eliminate hepatitis C,” Kowdley said. “And that needs to come along with awareness, funding and support. You only cure the people you treat.”²

Kowdley additionally advocated for the continued research and development of prophylactic or vaccination options, as well as long-acting forms of DAA therapy.

“I think we’ve got to get a better handle on virology to be able to develop effective vaccines,” Kowdley explained. “It’s a very unstable virus and it mutates very rapidly.”

Wester and colleagues noted from their analysis that each of diagnostics, treatment and preventive care needs to be better addressed in patients with HCV to achieve national elimination goals.

“Overcoming these barriers requires implementation of universal hepatitis C 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,” they concluded.

References

1. ^{Wester C, Osinubi A, Kaufman HW, et al. Hepatitis C Virus Clearance Cascade — United States, 2013–2022. MMWR Morb Mortal Wkly Rep 2023;72:716–720. DOI: http://dx.doi.org/10.15585/mmwr.mm7226a3}
2. ^{Kunzmann K. Kris Kowdley, MD: The Opioid Epidemic is Burdening Hepatitis C Elimination. HCPLive. Published May 13, 2023. https://www.hcplive.com/view/kris-kowdley-md-opioid-epidemic-burdening-hepatitis-c-elimination}