Thursday, May 30, 2024

U.S. Lags Behind Other Countries in Hepatitis-C Cures

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In the 10 years since the drugmaker Gilead debuted a revolutionary 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 during this decade, according to the Center for Disease Analysis Foundation, a nonprofit. Each has pursued a dogged national screening and treatment campaign.

But the arsenal of drugs, which have generated tens of billions of dollars for pharmaceutical companies, has not brought the United States any closer to eradicating the disease.

Spread through the blood including IV drug use, hepatitis C causes liver inflammation, though people may not display symptoms for years. Only a fraction of Americans with the virus are aware of the infection, even as many develop the fatal disease.

A course of medications lasting eight to 12 weeks is straightforward. But the most at-risk, including those who are incarcerated, uninsured or homeless, have difficulty navigating the American health system to get treatment.

Of those diagnosed in the United States since 2013, just 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, who heads the agency’s division of viral hepatitis. “We have models of care that are working, but it is a patchwork.”

Dr. Francis Collins, who headed 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 introduction of the new cures. An outdoorsman, Mr. Boterf 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 just 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 drugs for every patient it enrolled for treatment.

Several states already use similar subscription contracts, with limited success. Louisiana was the first to deploy such a scheme, in 2019, and reported a significant increase in people treated through Medicaid and in correctional facilities. But the state’s treatment numbers dwindled during the pandemic, and have not rebounded. Now, nearing the end of its five-year contract, Louisiana has treated barely half the people it had proposed to reach.

Dr. Collins acknowledged that on its own, a national drug-purchasing agreement like Louisiana’s would not be sufficient to turn the tide.

“Anybody who tries to say, ‘Oh, it’s just the cost of the drug, that’s the only thing that’s gotten 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 clinicians and promote treatment at health centers, prisons and drug treatment programs.

Carl Schmid, who directs the H.I.V. and Hepatitis Policy Institute, a nonprofit, said he worried that the White House proposal was overly focused on drug prices. “The real problem is you have to get money for the outreach, the testing and the providers,” he said.

Advocates say some states have cobbled together robust efforts, like New Mexico, which has been connecting hard-to-reach populations with 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 required to eradicate the disease by the end of this decade. “You can’t do that through just one door.”

In the village of Ruidoso, in southeastern New Mexico, 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 had not been trained to treat hepatitis C and offered to refer the patient to a gastroenterologist. But none practiced in the town, and the patient balked at traveling to Albuquerque, three hours away.

“I didn’t know where to go from there,” Ms. Haase said.

One of the biggest hurdles to eliminating hepatitis C is the specialists most qualified to treat the disease are often the least accessible to patients, especially those who lack insurance or stable shelter, both risk factors for infection.

Even when referrals are possible, they require follow-up visits that patients may miss and co-payments they may be unable to afford.

So instead of handing off the patient, Ms. Haase joined a video conference with other rural providers, where she presented the case, and more experienced clinicians recommended further tests and medications. The meeting was part of a program called ECHO (Extension for Community Healthcare 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 for more than 10,000 patients. “It really changed the game,” he said.

Care behind bars

Few people are at higher risk of hepatitis C infection than those who are incarcerated. A recent study estimated that over 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’s prisons did a good job of screening for hepatitis C and a terrible job 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 needed treatment. Prisons then rationed the drugs, including by denying medication to inmates accused of disciplinary infractions. In 2018, of some 3,000 infected inmates, just 46 received treatment.

That changed in 2020 when state lawmakers appropriated $22 million specifically for treating prisoners with hepatitis C. New Mexico’s corrections department also arranged to buy the medications at a steep discount through the 340 B federal drug pricing program.

But some prisoners continued to decline treatment, so the state enlisted incarcerated people to win them over. Since 2009, the Peer Education Project, a collaboration between Project ECHO and the corrections department, has trained more than 800 people to counsel others about preventing infections and getting treated.

Last May, incarcerated peer educators around the state tuned into a videoconference to discuss the reasons their fellow inmates were reluctant to seek treatment and to share their approaches for assuaging those concerns.

Daniel Rowan, who now manages the Prison Education Program, had himself formerly 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 gauntlet of challenges, to say the least.”

Between 2020 and 2022, the number of imprisoned people receiving treatment for hepatitis C quadrupled, to more than 600. Last year, the New Mexico State Legislature appropriated another $27 million to sustain the effort.

Another group it is crucial to reach are people with a history of IV drug use: Two-thirds of newly infected people had previously injected drugs, according to the C.D.C.

In New Mexico, where opiate addiction is a generational scourge, harm reduction programs are deeply integrated into the state’s public health department. The state legalized needle exchanges 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 paired treatment for hepatitis C with existing services including needle-exchange and prescriptions for buprenorphine, an opioid addiction treatment. Over the next year, a lower-than-expected share of patients in the buprenorphine program tested positive for hepatitis C, which health officer Dr. Michael Bell attributed, in part, to changes in drug use. People who once injected heroin now smoke fentanyl instead, limiting their exposure to unsanitary needles that could transmit the virus. The C.D.C. believes this shift also contributed to a slight decline in new hepatitis C infections nationwide, which fell 3.5 percent in 2022.

Still not enough

Despite statewide efforts, no tracking system exists to accurately measure the number of people cured. A little more than 2,200 people were treated in 2022 by the largest providers. The state estimated it needed to treat 4,000 people that year to stay on track.

As in other states, clinicians in New Mexico also struggle to persuade patients to return and begin treatment. Some countries have approved a rapid test that makes it possible to diagnose and start treatment in one visit. The test is under accelerated review at the National Institutes of Health in the United States, with data 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 few opportunities to pass it before the election in November.

The Congressional Budget Office is evaluating a draft bill for its impact on the budget. Dr. Collins acknowledged that lawmakers in Congress might balk at the price tag, but contended that it would eventually save not just lives, but money.

In a paper published by the National Bureau of Economic Research, a group of scientists calculated that the initiative would prevent 24,000 deaths in the next decade and save $18.1 billion in medical costs for people with untreated hepatitis C.

“This is a deficit reduction program in the long term,” Dr. Collins said. “Just don’t expect it to be deficit reduction this year.”




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