In the 10 years since drugmaker Gilead launched a breakthrough treatment for hepatitis C, a wave of new therapies have been used to cure millions of people around the world from 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 Center for Disease Analysis Foundation, a nonprofit organization. Each pursued a dogged national screening and treatment campaign.
But the arsenal of drugs, which have brought tens of billions of dollars to pharmaceutical companies, has not brought the United States any closer to eradicating the disease.
Spread through the blood including intravenous drug use, hepatitis C causes inflammation of the liver, although people may not show symptoms for years. Only a fraction of Americans with the virus are aware of the infection, although many develop the deadly disease.
A course of medication lasting 8-12 weeks is simple. But those most at risk, including those who are incarcerated, uninsured or homeless, have difficulty navigating the American health care system to get care.
According to a recent Centers for Disease Control and Prevention analysis, of those diagnosed in the United States since 2013, only 34 percent have been treated.
“We are not making progress,” said Dr. Carolyn Wester, who heads the agency's viral hepatitis division. “We have care models that work, but it's a patchwork.”
Dr. Francis Collins, who ran the National Institutes of Health for decades until he retires in 2021, has led a White House initiative aimed at eliminating the disease.
In an interview he said he was motivated by the memory of his brother-in-law Rick Boterf, who died of hepatitis C shortly before the new treatments were introduced. An outdoorsman, Boterf endured five years of liver failure while waiting for a transplant, and not even that procedure was enough to save him from the destructive virus.
“The more I looked at this, the more it seemed impossible to leave,” Dr. Collins said.
The initiative, included in President Biden's latest budget proposal, provides about $5 billion to establish a five-year “subscription” contract. The federal government would pay a flat fee and, in exchange, receive drugs for each patient enrolled for treatment.
Several states already use similar subscription contracts, with limited success. Louisiana was the first to implement such a scheme, in 2019, and reported a significant increase in people treated through Medicaid and in correctional facilities. But the number of state treatments has declined during the pandemic and not increased. Now, nearing the end of its five-year contract, Louisiana has treated barely half the people it set out to reach.
Dr. Collins acknowledged that, alone, a national drug purchasing agreement like Louisiana's would not be enough to reverse the trend.
“Anyone who tries to say, 'Oh, it's just the cost of the drug, that's the only thing that's in the way,' hasn't carefully considered those lessons,” 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 HIV and Hepatitis Policy Institute, a nonprofit, said he was concerned that the White House proposal was overly focused on drug prices. “The real problem is you have to get money for outreach, testing and suppliers,” he said.
Supporters say some states have put together robust efforts, such as New Mexico, which has connected 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 runs the state's hepatitis C program, said about 25,800 residents need treatment and that multiple strategies will be needed to eradicate the disease by the end of this decade. “You can't do it through just one door.”
In the village of Ruidoso in southeastern New Mexico, Christie Haase, a registered nurse, 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 no one 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 hepatitis C. 'infection.
Even when hospitalizations 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 attended a video conference with other rural providers, where she presented the case, and more experienced doctors 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 physicians 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. “He really changed the game,” he said.
Be careful behind bars
Few people are at greater risk of hepatitis C infection 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 have done a good job of screening for hepatitis C and a poor job of treating it. More than 40% of prisoners were infected, the highest prevalence of any state prison system, but no funds were available for necessary treatment. Prisons then rationed drugs, including denying drugs to inmates accused of disciplinary infractions. In 2018, of approximately 3,000 infected prisoners, only 46 received treatment.
That changed in 2020, when state lawmakers allocated $22 million specifically for the treatment of prisoners with hepatitis C. The New Mexico Department of Corrections also arranged to purchase the drugs at a steep discount through the federal program on drug prices 340 B.
But some prisoners continued to refuse treatment, so the state enlisted inmates to convince 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 infection prevention and treatment.
Last May, incarcerated peer educators across the state tuned into a video conference to discuss the reasons their incarcerated peers were reluctant to seek treatment and to share their approaches to alleviating those concerns.
Daniel Rowan, who now runs the Prison Education Program, had himself been incarcerated in the past. He said the program has done much to improve the relationship between inmates and their healthcare providers, although it remains “a challenge full of challenges, to put it mildly.”
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 appropriated an additional $27 million to support the effort.
Another group that is critical to reach are people with a history of intravenous drug use: According to the CDC, two-thirds of newly infected people had previously used intravenous drugs.
In New Mexico, where opioid addiction is a generational plague, 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 distribution of naloxone.
Early last year, a Las Cruces County public health clinic combined hepatitis C treatment with existing services, including needle exchange and prescriptions for buprenorphine, a treatment for opioid addiction. Over the next year, a lower-than-expected percentage of patients in the buprenorphine program tested positive for hepatitis C, which health officer Dr. Michael Bell attributed, in part, to changes in the use of the drugs. People who once injected heroin now smoke fentanyl instead, limiting their exposure to unsanitary 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 by 3.5% in 2022.
Still not enough
Despite efforts at the state level, there is no tracking system to accurately measure the number of people who have recovered. 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 in line.
As in other states, doctors in New Mexico struggle to convince patients to return and begin treatment. Some countries have approved a rapid test that allows you to diagnose and start treatment in one visit. The test is under accelerated review at the National Institutes of Health in the US, 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 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 congressional lawmakers might balk at the price tag, but argued that it would ultimately save not just lives, but money.
In an article published by the National Bureau of Economic Research, a group of scientists calculated that the initiative could 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 deficit reduction this year.”