Today’s hepatitis C medications are highly effective, but only a third of people with the virus have been successfully treated, hampering efforts to eliminate the life-threatening disease, according to a new report from the Centers for Disease Control and Prevention (CDC). The numbers are even worse for young people and those without health insurance.
While this study looked at cure rates, increased screening and diagnosis are also needed, according to Carolyn Wester, MD, of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention. “Everyone with hepatitis C deserves the chance to be cured,” she said at a June 29 media briefing.
A new @CDCMMWR reports that cures for hepatitis C fail to reach most Americans who need them—a decade after breakthrough treatments were first approved. Learn more: https://t.co/lgQKy6Cod7 pic.twitter.com/F8vXHFdVEL— CDC (@CDCgov) June 29, 2023
Estimates suggest that more than 2 million people in the United States have hepatitis C. Over time, chronic hepatitis C virus (HCV) infection can lead to liver fibrosis, cirrhosis, liver cancer and the need for a liver transplant. Available for a decade, modern direct-acting antivirals—including Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir)—can cure more than 95% of people with HCV in two or three months, but treatment remains out of reach for many.
“Tens of thousands of Americans with hepatitis C are getting liver cancer, suffering liver failure or dying because they can’t access lifesaving medicine,” Jonathan Mermin, MD, MPH, director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in a press release. “In our nation, no one should have to live knowing a cure for their potentially deadly disease is available, but out of reach.”
The Viral Hepatitis National Strategic Plan for the United States calls for at least 80% of people with hepatitis C to be cured by 2030. To evaluate progress toward this goal, Wester and colleagues analyzed the HCV clearance cascade using data from Quest Diagnostics, a large national commercial laboratory, collected between 2013—when the first direct-acting antiviral was approved—and 2022.
A total of 1,719,493 people were identified as ever having been infected with HCV, as indicated by a positive antibody, HCV RNA or HCV genotype test. Most (88%) received follow-up HCV RNA testing, and 1,042,082 people (69%) were found to have initial active infection with a detectable viral load. Within this group, 34% were considered cured, having either naturally cleared the virus or been successfully treated—a “jarringly low” rate, Wester said. Of these, 7% subsequently experienced viral rebound and were considered to have persistent HCV infection or reinfection.
However, the likelihood of being diagnosed, treated and cured varied widely by age and health insurance status.
Among people who ever had HCV, 60% were men, 29% were ages 20 to 39, 43% were ages 40 to 59 and 27% were ages 60 or older. These figures show that hepatitis C is no longer primarily a concern for baby boomers. People ages 20 to 29 were least likely to be cured (24%) and those 60 or older were most likely (42%). Those ages 20 to 39 were most likely to have persistent infection or reinfection after being cured, suggesting ongoing risk.
Half of people who ever had HCV were covered by commercial health insurance, 11% by Medicaid and 8% by Medicare. This left about 30% covered by other payers, self-payment, an unspecified payer or uninsured. People on Medicare were most likely to be cured (45%), followed by those with commercial insurance (40%), those on Medicaid (31%) and those who relied on other payers or were uninsured (23%). The cure rate was only 16% for inaequately insured people under age 40.
“This simplified national HCV clearance cascade identifies substantial gaps in cure nearly a decade since highly effective direct-acting antiviral agents became available,” the study authors concluded. “It is essential that increased access to diagnosis, treatment and prevention services for persons with hepatitis C be addressed to prevent progression of disease and ongoing transmission and achieve national hepatitis C elimination goals.”
Barriers to hepatitis C treatment include inadequate screening and diagnosis (such as a cumbersome two-step process of antibody and HCV RNA testing), the high cost of medications and restrictive treatment coverage policies. These include, for example, treating only people with advanced fibrosis, requiring a period of abstinence from drugs and alcohol, limiting treatment to liver specialists or requiring prior authorization from insurers. “All of these restrictions can delay or even prohibit access to these life-saving medications,” according to Wester.
“We have a cure for a serious infectious disease, but people who have taken the time to get tested and know they have hepatitis C are not being cured,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “The vast majority of these people have health coverage but payers such as private insurers, state Medicaid programs and Medicare are erecting barriers to patient access by not covering medications or requiring cumbersome prior authorizations or imposing high patient cost-sharing. If the federal government is serious about ending hepatitis C, it needs to provide the leadership, particularly at [the Centers for Medicare & Medicaid Services], and address these payer barriers.”
Lack of awareness about the effectiveness and tolerability of modern treatment may also be a barrier for some. “The cure that’s been around for 10 years is very simple,” said former National Institutes of Health director Francis Collins, MD, PhD, who heads up the White House National Hepatitis C Elimination Program. “A lot of people remember the bad old days when the treatment for hepatitis C [interferon-based therapy] was very toxic and didn’t always work."
To achieve elimination, the White House has requested $11 billion in funding to increase testing and treatment. The administration aims to lower the cost by purchasing a large quantity of the medications at a negotiated price. The drugs would then be made available for free, for example, to incarcerated people, uninsured people and those served by Native American health services. Making this investment now could save not only tens of thousands of lives but also billions of dollars over the next two decades as timely antiviral therapy reduces the need to treat liver cancer and liver failure, according to Collins.
“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 study authors wrote. “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.”
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