In the 10 years since drugmaker Gilead first introduced a breakthrough treatment for hepatitis C, a wave of new therapies have been used to cure millions of people around the world of the blood-borne virus.
Today, 15 countries, including Egypt, Canada and Australia, are on track to eliminate hepatitis C within this decade, according to the nonprofit Center for Disease Analysis Foundation. Each of them has carried out a tenacious national detection and treatment campaign.
But the arsenal of drugs, which has generated tens of billions of dollars for pharmaceutical companies, has not brought the United States any closer to eradicating the disease.
Hepatitis C, which is transmitted through blood, including through intravenous drug use, causes inflammation of the liver, although people may not have symptoms for years. Only a fraction of Americans who have the virus are aware of the infection, although many develop the deadly disease.
A course of medication lasting eight to 12 weeks is easy. But those most at risk, including those who are incarcerated, uninsured or homeless, have difficulty navigating the American healthcare system for treatment.
Of those diagnosed in the United States since 2013, only 34 percent have been cured, according to a recent analysis by the Centers for Disease Control and Prevention.
“We’re not making progress,” said Dr. Carolyn Wester, director of the agency’s viral hepatitis division. “We have models of care that are working, but it is a mosaic.”
Dr. Francis Collins, who led the National Institutes of Health for decades until retiring in 2021, has been spearheading a White House initiative aimed at eliminating the disease.
In an interview, he said he was motivated by memories of his brother-in-law, Rick Boterf, who died of hepatitis C just before the new cures were introduced. Boterf, a nature lover, endured five years of liver failure waiting for a transplant, and even that procedure wasn’t enough to save him from the destructive virus.
“The more I looked at this, the more it seemed impossible to walk away,” Dr. Collins said.
The initiative, which was included in President Biden’s latest budget proposal, calls for about $5 billion to establish a five-year “subscription” contract. The federal government would pay a flat fee and, in return, receive medications for each patient it signed up for treatment.
Several states already use similar underwriting contracts, with limited success. Louisiana was the first to implement such a plan, in 2019, and reported a significant increase in people treated through Medicaid and in correctional facilities. But treatment numbers in the state declined during the pandemic and have not recovered. Now, nearing the end of its five-year contract, Louisiana has treated just half the people it set out to reach.
Dr. Collins acknowledged that a national drug purchasing agreement like the one in Louisiana alone would not be enough to change the situation.
“Anyone who tries to say, ‘Oh, it’s just the cost of the drug, that’s the only thing that gets in the way,’ hasn’t looked at those lessons carefully,” he said. To that end, the proposal also calls for a $4.3 billion campaign to raise awareness, train doctors and promote treatment in health centers, prisons and drug treatment programs.
Carl Schmid, who directs the nonprofit HIV and Hepatitis Policy Institute, said he was concerned that the White House proposal focused too much on drug prices. “The real problem is that you have to find money for outreach, testing and providers,” he said.
Advocates say some states have cobbled together robust efforts, like New Mexico, which has been connecting hard-to-reach populations to treatment, largely without federal support.
“New Mexico is one of our superstars,” said Boatemaa Ntiri-Reid, a health policy expert with the National Alliance of State and Territorial AIDS Directors.
Andrew Gans, who manages the state’s hepatitis C program, said an estimated 25,800 residents needed treatment and that multiple strategies would be needed to eradicate the disease by the end of this decade. “You can’t do that through just one door.”
In the southeastern New Mexico town of Ruidoso, Christie Haase, a nurse practitioner, had been working at a small private clinic for just two weeks when a patient with abnormal liver enzymes tested positive for hepatitis C.
Like many primary care providers, Ms. Haase was not trained to treat hepatitis C and offered to refer the patient to a gastroenterologist. But none of them practiced in the city and the patient was reluctant to travel to Albuquerque, three hours away.
“I didn’t know where to go from there,” Ms. Haase said.
One of the biggest obstacles to eliminating hepatitis C is that the specialists most qualified to treat the disease are often the least accessible to patients, especially those who lack insurance or stable housing, both risk factors for infection.
Even when referrals are possible, they require follow-up visits that patients may miss and copays they may not be able to afford.
So instead of handing over the patient, Ms. Haase joined a video conference with other rural providers, where she presented the case and more experienced doctors recommended more tests and medications. The meeting was part of a program called ECHO (Extension for Community Health Care Outcomes), which Dr. Sanjeev Arora, a gastroenterologist, developed in the early 2000s to connect primary care doctors in sparsely populated areas with specialists. .
Dr. Arora, who later founded the nonprofit Project ECHO to promote the model around the world, estimated that the New Mexico program had provided hepatitis C treatment to more than 10,000 patients. “It really changed the game,” he said.
Care behind bars
Few people are at greater risk of contracting hepatitis C than those who are incarcerated. A recent study estimated that more than 90,000 people in U.S. state prisons are infected, 8.7 times the prevalence of people outside the correctional system.
For many years, New Mexico prisons did a good job of screening for hepatitis C and a terrible job of treating it. More than 40 percent of prisoners were infected, the highest prevalence of any state correctional system, but no funds were available for the necessary treatment. Prisons then rationed medications, even denying medications to inmates accused of disciplinary infractions. In 2018, of about 3,000 infected inmates, only 46 received treatment.
That changed in 2020, when state lawmakers allocated $22 million specifically to treat prisoners with hepatitis C. The New Mexico Department of Corrections also arranged to purchase the drugs at a deep discount through the federal drug pricing program. 340 B.
But some prisoners continued to refuse treatment, so the state recruited incarcerated people to win them over. Since 2009, the Peer Education Project, a collaboration between Project ECHO and the department of corrections, has trained more than 800 people to advise others on how to prevent infections and receive treatment.
Last May, incarcerated peer educators across the state tuned into a video conference to discuss the reasons their fellow inmates were reluctant to seek treatment and share their approaches to alleviating those concerns.
Daniel Rowan, who now runs the Prison Education Program, had previously been incarcerated. He said the program had gone a long way toward improving the relationship between inmates and their medical providers, although it remains “a set of challenges, to say the least.”
Between 2020 and 2022, the number of incarcerated people receiving treatment for hepatitis C quadrupled, to more than 600. Last year, the New Mexico State Legislature allocated another $27 million to sustain the effort.
Another group that’s crucial to reach are people with a history of intravenous drug use: Two-thirds of newly infected people had previously injected drugs, according to the CDC.
In New Mexico, where opioid addiction is a generational scourge, harm reduction programs are deeply integrated into the state’s public health department. The state legalized needle exchange more than 25 years ago and was the first to allow the distribution of naloxone.
Early last year, a county public health clinic in Las Cruces combined hepatitis C treatment with existing services, including needle exchanges and prescriptions for buprenorphine, a treatment for opioid addiction. Over the next year, a smaller-than-expected proportion of patients in the buprenorphine program tested positive for hepatitis C, which health official Dr. Michael Bell attributed, in part, to changes in drug use. People who once injected heroin now smoke fentanyl, limiting their exposure to unsafe needles that could transmit the virus. The CDC believes this change also contributed to a slight decline in new hepatitis C infections nationwide, which fell 3.5 percent in 2022.
It’s still not enough
Despite efforts at the state level, there is no tracking system to accurately measure the number of people cured. In 2022, the largest providers treated just over 2,200 people. The state estimated it needed to treat 4,000 people that year to stay on track.
As in other states, New Mexico doctors also struggle to persuade patients to return and begin treatment. Some countries have approved a rapid test that allows diagnosis and initiation of treatment in a single visit. The test is under accelerated review at the U.S. National Institutes of Health and data is expected to be ready this summer, an agency spokesperson said.
The president’s initiative was also in last year’s budget, but lawmakers have not yet introduced legislation to fund it, and there may be little opportunity to pass it before the November elections.
The Congressional Budget Office is evaluating a bill for its impact on the budget. Dr. Collins acknowledged that lawmakers in Congress might oppose the price tag, but argued that it would eventually save not only lives but money.
In a paper published by the National Bureau of Economic Research, a group of scientists estimated that the initiative would prevent 24,000 deaths over the next decade and save $18.1 billion in medical costs for people with untreated hepatitis C.
“This is a long-term deficit reduction program,” Dr. Collins said. “Just don’t expect any deficit reduction this year.”
