In the decade since pharmaceutical company Gilead introduced an innovative treatment for hepatitis C, new treatments have been used to treat millions of people around the world infected with the blood-borne virus. It has been.
Fifteen countries, including Egypt, Canada and Australia, are now on track to eliminate hepatitis C within the next decade, according to the nonprofit Center for Disease Analysis. Each has doggedly pushed for a national testing and treatment campaign.
But the drug stockpiling, which has generated tens of billions of dollars in profits for pharmaceutical companies, is not bringing the United States any closer to eradicating the disease.
Hepatitis C is spread through the blood, including through intravenous drug use, and causes inflammation of the liver, but symptoms may not appear for years. Only a small percentage of Americans infected with the virus are aware of their infection, even though many Americans develop the deadly disease.
The course of medication over 8 to 12 weeks is simple. But those most at risk, such as the incarcerated, the uninsured, and the homeless, have difficulty accessing the U.S. health care system to receive treatment.
Only 34 percent of patients diagnosed in the U.S. since 2013 have been cured, according to a recent analysis from the U.S. Centers for Disease Control and Prevention.
“We're not making progress,” said Dr. Carolyn Wester, director of the agency's viral hepatitis division. “There are care models that are working well, but they are patchy.”
Dr. Francis Collins, who headed the National Institutes of Health for decades before retiring in 2021, has been at the forefront of the White House's efforts to eliminate the disease.
He said in an interview that he was motivated by the memory of his brother-in-law, Rick Beauturf, who died of hepatitis C just before new treatments were introduced. Mr Beauturf, an outdoorsman, endured liver failure for five years while waiting for a transplant, but even that surgery wasn't enough to save him from the devastating virus.
“The more I looked, the more it seemed impossible to walk away,” Dr. Collins said.
The initiative, included in President Biden's latest budget proposal, calls for about $5 billion to establish five-year “subscription” agreements. The federal government would pay a flat fee and in return, every patient who enrolled in treatment would receive the drug.
Some states already use similar subscription agreements, but with limited success. Louisiana first introduced such a program in 2019 and reported significant increases in the number of people receiving treatment through Medicaid and in correctional facilities. But the number of patients in the state has declined during the pandemic and has not recovered. Now nearing the end of a five-year contract, Louisiana has treated just half of the people it was offering to serve.
Dr. Collins acknowledged that national drug purchase agreements like Louisiana's are not enough to turn the tide.
“People who say, 'Oh, it's just the drug costs, that's the only thing that's getting in the way,' are not looking at these lessons carefully,” he says. To that end, the proposal also calls for a $4.3 billion campaign to raise awareness, train clinicians, and facilitate treatment in health centers, prisons, and drug treatment programs.
Carl Schmidt, director of the nonprofit HIV and Hepatitis Policy Institute, said he was concerned that the White House's proposal focused too much on drug prices. “The real problem is we have to raise money for outreach, testing and health care providers,” he says.
Advocates say they are mobilizing a powerful effort, with some states like New Mexico connecting hard-to-reach people to treatment with little federal aid.
“New Mexico is one of our superstars,” said Boatemaa Ntiri-Reed, a health policy expert with the National Association of State and Territorial AIDS Directors.
Andrew Gans, who runs the state's hepatitis C program, said an estimated 25,800 residents need treatment and multiple strategies will be needed to eliminate the disease by the end of the decade. He said he was deaf. “You can't do it through just one door.”
Nurse Kristi Haas had been working in a small private clinic in the southeastern New Mexico village of Ruidoso for just two weeks when a patient with abnormal liver enzymes tested positive for hepatitis C.
Like many primary care providers, Haas has no training in treating hepatitis C and offered to refer the patient to a gastroenterologist. But no one was practicing in town, so patients were reluctant to travel to Albuquerque, three hours away.
“I didn't know where to go from there,” Haase said.
One of the biggest obstacles to eliminating hepatitis C is that the experts best suited to treat hepatitis C are the most accessible to patients, especially those without insurance or stable shelter, risk factors for infection. This is often difficult to do.
Even if a referral is possible, a follow-up visit is required, which means patients may not be able to see the doctor and be unable to pay their co-payments.
So instead of handing over the patient, Haas participated in a video conference with other local health care providers, where she presented her case and a more experienced clinician recommended further tests and medication. The conference was held as part of a program called ECHO (Extension for Community Healthcare Outcomes). The program was developed by gastroenterologist Dr. Sanjeev Arora in the early 2000s to connect primary care physicians and specialists in sparsely populated areas.
Dr. Arora, who later founded the nonprofit Project ECHO to promote this model around the world, estimated that the New Mexico program 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 hepatitis C infection than people who are incarcerated. A recent study estimates that more than 90,000 people in state prisons in the United States are infected, which is 8.7 times the number of people infected outside the correctional system.
For years, New Mexico prisons have done a poor job of screening for and treating hepatitis C. More than 40 percent of prisoners were infected, the highest infection rate in the state's correctional system, but there was no funding available for needed treatment. The prison then rationed drugs, including denying medication to inmates accused of disciplinary violations. In 2018, only 46 of the approximately 3,000 infected prisoners received treatment.
That changed in 2020 when the state Legislature earmarked $22 million specifically to treat inmates with hepatitis C. New Mexico's Department of Corrections also arranged to purchase drugs at deep discounts through the $340 billion federal drug pricing program.
However, some prisoners continued to refuse treatment, so the state recruited inmates to persuade them. 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 infectious disease prevention and treatment.
Last May, educators in prisons across the state participated in a video conference to discuss the reluctance of their fellow inmates to seek treatment and share approaches to allay those concerns. did.
Daniel Rowan, who currently manages the prison education program, was previously incarcerated himself. He said the program has made a significant contribution to improving relationships between inmates and health care providers, but “challenges abound, to say the least.”
Between 2020 and 2022, the number of inmates receiving treatment for hepatitis C quadrupled to more than 600. Last year, the New Mexico Legislature appropriated an additional $27 million to sustain the effort.
Another group that is important to approach is people with a history of IV drug use. According to the CDC, two-thirds of new infections have previously injected drugs
In New Mexico, where opiate addiction is a generational scourge, harm reduction programs are deeply embedded in 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, the county public health clinic in Las Cruces combined hepatitis C treatment with existing services such as needle exchanges and prescribing buprenorphine, an opioid addiction treatment drug. In the following year, a lower proportion of patients in the buprenorphine program tested positive for hepatitis C than expected, which health officer Dr. Michael Bell attributed in part to changes in drug use. People who once injected heroin are now smoking fentanyl instead, limiting exposure to unsanitary needles that can transmit the virus. The CDC believes this change also contributed to a slight decline in the number of new hepatitis C infections nationwide, resulting in a 3.5% decline in 2022.
Still not enough
Despite statewide efforts, no tracking system exists to accurately measure how many people have been cured. In 2022, just over 2,200 people will be treated by the largest healthcare providers. The state estimated it needed to treat 4,000 people that year to get the program off the ground.
Like other states, New Mexico clinicians are having a hard time convincing patients to return and start treatment. Some countries have approved rapid tests that allow diagnosis and initiation of treatment in a single visit. The test is under expedited review at the National Institutes of Health, and data is expected to be completed this summer, an agency spokeswoman said.
The president's initiative was included in last year's budget, but lawmakers have yet to introduce a bill to finance it and there may be little chance of passing it before November's election.
The Congressional Budget Office is evaluating the bill for its budgetary impact. Dr. Collins acknowledged that members of Congress may balk at the price tag, but argued that in the end it would save not only lives but money.
In a paper published by the National Bureau of Economic Research, a group of scientists say the initiative could prevent 24,000 deaths and save $18.1 billion in medical costs for untreated hepatitis C patients over the next 10 years. I calculated it.
“This is a long-term deficit reduction program,” Dr. Collins said. “Don’t expect deficit reduction this year.”