HCV Cure and Clearance Rates Remain Low, Despite New Therapies

A new report from the Centers for Disease Control and Prevention (CDC) indicates that despite the availability of direct-acting antivirals (DAAs), only about one-third of people with hepatitis C viral infection (HCV) are achieving viral clearance.¹

The study’s authors say the report shows there is still much work to be done to increase access to DAAs and improve diagnosis and prevention efforts. The data were published in the CDC’s Morbidity and Mortality Weekly Report.

It’s been nearly a decade since the Food and Drug Administration (FDA) approved the first DAAs for the treatment of HCV. DAAs are recommended for nearly all people with HCV, and 95% of those who complete a course of therapy will achieve viral clearance, noted corresponding author Carolyn Wester, MD, MPH, the director of the CDC’s Division of Viral Hepatitis.

As a result, when the Department of Health and Human Services published its latest Viral Hepatitis National Strategic Plan in 2021, officials set the goal of eliminating viral hepatitis as a public health threat in the United States. More concretely, that translated into a goal of achieving viral clearance in at least 80% of people diagnosed with HCV by the year 2030.

In the new report, Wester and colleagues offered an update on progress toward that goal. Using deidentified data from a large national commercial laboratory, the investigators constructed a database of all people who were ever infected with HCV between January 1, 2013 and December 31, 2021. They then tracked those patients to create a simplified national HCV clearance cascade to see how far patients made it through the recommended continuum of care.

The database showed that a total of 1.7 million people were identified as having HCV between 2013 and 2021. By December 31, 2022, 88% of those patients had received viral testing. Of those tested, 69% were classified as having initial infection. Among those with initial infection, just 34% went on to be classified as cured or cleared, either due to treatment of spontaneous clearance. Of those achieving viral clearance, 7% were classified as having persistent infection or reinfection, the authors said.

In a press release, Wester said the data are concerning, “because nearly a decade after having a breakthrough cure, only 1 out of 3 people diagnosed with Hepatitis C have been cured.”²

The investigators found that people in the 20-29-year-old age range had the lowest rate of cure or clearance (24%), while patients ages 60 and older had the highest rate (42%). In terms of payor type, patients on Medicare had the highest cure or clearance rate (45%). The lowest rate—23%—was recorded for people whose payor type was listed as “other” (meaning they did not list a commercial or government insurer).

Wester cited a variety of hurdles standing in the way of achieving the government’s HCV elimination strategy.

“I think there are multiple factors leading to low cure rates among people with Hepatitis C—certainly, the high cost of treatment and associated insurance restrictions,” she said. “And we also need to ensure that testing and treatment is available in all settings where people with Hepatitis C receive care.”

Wester said the Biden Administration has proposed a national plan to boost access to rapid diagnosis, testing, and treatment.

Though HCV can be transmitted through unsafe injection practices and is commonly associated with injection drug use, Wester noted that people can be at risk of HCV through various other means. For instance, the virus can be transmitted through sexual intercourse, and an expectant mother can pass it on to her child.

“Hepatitis C is a silent killer,” she said. “Most people do not know they have Hepatitis C until they’re in late stages of disease. It’s essential that all Americans get tested at least once in their lifetime.”

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(26):716-720. doi:10.15585/mmwr.mm7226a3

2. Breakthrough cures for hepatitis C still fail to reach the vast majority of Americans who need them. News release. CDC. June 29, 2023. Accessed July 7, 2023. https://www.cdc.gov/media/releases/2023/p0629-hepatitis-c.html