AZARD, Ky. — The patients here ask about the treatment by name. They’ve seen the crisp, alluring ads on TV and heard the soothing spots on the radio: Harvoni, they know, could cure their hepatitis C.
But in this town, carved into the Appalachian mountains, in a state beset by hepatitis C rates seven times the national average, Harvoni and other new hepatitis C drugs remain largely out of reach. Over the past year, only 3 percent of the state’s Medicaid beneficiaries with the disease received treatment.
“It’s very hard to see the patient and just tell them, ‘I can’t treat you,’” said Dr. Fares Khater, an infectious disease doctor in nearby Whitesburg.
A major reason is cost, with list prices for some 12-week treatment courses approaching $100,000. But a series of other forces helps explain why Kentucky is struggling to respond to the hepatitis C crisis, including a growing opioid epidemic that is fueling new cases and a changing patient base that is demanding hard choices be made about who gets treatment first.
With opioid use seeding the spread of infectious disease across the country, this state could be a case study in how hepatitis C affects other areas, and what happens when demands for specialists, surveillance, and treatment outstrip the ability of health systems to respond.
“We don’t have the capability to deal with this because we don’t have the resources,” said Doug Thoroughman, Kentucky’s acting state epidemiologist.
Hepatitis C is a viral disease that attacks the liver and, when the condition becomes chronic, causes liver cancer and scarring called fibrosis or, when it’s severe, cirrhosis. The disease is the leading cause of liver transplants in the country, and an estimated 19,000 people die from hepatitis C-related complications each year.
Most people with the disease experience symptoms only when their livers suffer damage, which can take years after they contract the virus. That leaves many of the 2.7 million to 3.9 million Americans with hepatitis C carrying it unknowingly.
Three years ago, the first of the innovative hepatitis C drugs marched onto the market, signaling a new era for patients who could be cured in a shorter time and with fewer side effects. But the reality is that many of the people who need the drugs are uninsured or depend on Medicaid, and many state Medicaid programs can’t afford the medications for their thousands of infected beneficiaries.
In fiscal 2016, hepatitis C treatments — delivered to fewer than 900 of the 29,000 hepatitis C patients covered by Kentucky’s Medicaid program — ate up 5 percent of the program’s pharmacy budget.
Access to the drugs could grow more limited. Kentucky has so many beneficiaries with hepatitis C because it expanded Medicaid coverage under the Affordable Care Act to more than 425,000 additional residents. But those residents stand to lose their coverage if President-elect Donald Trump and congressional Republicans repeal President Obama’s health law without offering a replacement.
Even if the Medicaid expansion remains in place, state proposals could impose new restrictions. Republican Governor Matt Bevin has asked the federal government to allow Kentucky to make many beneficiaries pay premiums, framing it as a way to sustain the expensive expansion.
Advocates for underserved populations are raising alarms, arguing even small fees would be too expensive for many to keep their insurance.
“Our population here are people that dig change to buy a gallon of gas, maybe to get to work, maybe to get to a doctor’s appointment,” said Mary Meade-McKenzie, the executive director of Kentucky River Community Care, a mental health and substance abuse organization based in Hazard. “For people who already have nothing, $2 is a huge deal. It may mean the difference between buying dinner, whether that’s a loaf of bread or bologna or whatever.”
Hepatitis C was once associated with baby boomers, many of whom were infected through blood transfusions before the blood supply started being screened for the virus in 1992. Later, the virus was seen as a scourge of urban drug use.
Drug users who share needles or other injection tools still account for most new cases of hepatitis C.
But with the opioid epidemic steamrolling through Appalachia and New England, the new face of the disease is increasingly young, white, and rural. From 2006 to 2012, hepatitis C infections rose 364 percent among young adults in Kentucky, Tennessee, West Virginia, and Virginia, with rates in rural areas twice as high as those in urban areas, according to the Centers for Disease Control and Prevention.
Because state Medicaid programs are unable to cover all beneficiaries with hepatitis C, they have had to make choices. To qualify for treatment, some beneficiaries in Kentucky, for example, must have stage 3 or 4 liver fibrosis (on a four-stage scale) and show they have not used alcohol or drugs for six months, in part to reduce the chances that someone treated gets reinfected.
Liver specialists and infectious disease experts have endorsed treating the sickest patients first, although they recommend that everyone who isn’t going to die of another cause within a year should be treated.
“You need everybody to be cured,” said Dr. Uday Shankar, a Hazard gastroenterologist who estimated that only 10 percent to 20 percent of his patients have been approved for treatment. “If you don’t cure them today, one person will transmit to five people. Especially youngsters — they have a long way to go.”
Shankar said he spends chunks of his days helping patients appeal denials for insurance coverage, scanning clinical trial listings, and asking companies what they offer patients who can’t afford their medications. He and Khater are the only specialists who treat hepatitis C for at least seven counties.
Up the road from Hazard, crossing from Perry County into Knott County, Laura Combs has given more than her fair share of hepatitis C diagnoses.
Combs, a family nurse practitioner, takes the opportunity to do what she calls “extreme teaching,” explaining to patients the factors that exacerbate the disease; the risks of cirrhosis, liver failure, and liver cancer; and the importance of safely cleaning up blood if they cut themselves.
“They need to know how this virus is going to attack their body,” she said. “They need to know how it could attack their loved ones if their loved ones come in contact with their blood.”
When Thomas Payne, 38, was told he had hepatitis C, it didn’t come as a surprise. He said he had abused alcohol and drugs for over two decades — “You name it, I did it” — and shared needles with people he knew had the virus, as well as HIV. But he said it still was a crushing blow, making him wonder if others would want to date him or even be near him.
“I was never going to be able to have what normal people have,” he said.
Payne, who abused drugs and recovered in the Louisville area, now lives in the Hazard area doing peer support. He was also one of the lucky 20 percent of people who get an acute hepatitis C infection, but then clear the virus and do not develop chronic disease.
“I’m really grateful,” he said. “It gives me another reason to stay sober.”
Health officials here say they were woken up to the area’s vulnerability by something that happened more than 200 miles away: an HIV outbreak in Austin, Ind. Not only did the outbreak show that diseases could vault through close networks of drug users in small towns, but by coincidence, the towns are closely linked.
Decades ago, a crowd of people from Hazard moved to Austin for work but kept family ties in Kentucky. The fear was that someone from Austin infected with HIV would come to Hazard and pass the virus to someone here, igniting another viral conflagration in this tight-knit community of 5,000 people. High hepatitis C rates can also portend an HIV outbreak, but eastern Kentucky has so far been spared from that.
“There was a direct connection,” said Sharon Dunaway, the nursing administrator for the Kentucky River District Health Department, which provides health services in seven counties in this area.
Since then, the department has joined with clinicians, mental health providers, and law enforcement to raise awareness about the diseases in the community. Officials have ramped up testing for both HIV and hepatitis C, including at drug courts. They’ve considered testing at county jails in the area, but there is concern that the counties would then be responsible for covering their inmates’ treatments. Now officials are thinking of doing the tests as people are released.
They are also working to establish the region’s first needle exchange, possibly a mobile one so people do not have to travel far to reach it. Going from one end of a county to the other here can take some time, the roads weaving around the mountains and many people living in hollows, small pockets tucked into the hillsides.
But new headwinds are complicating efforts to control the spread of the disease. The decline of the coal industry, which residents say accelerated in the past two years, has hit the tax base and sent many people seeking work elsewhere. Some health workers said they feared that the only young adults who would stick around would be people who abuse drugs.
Then there are the drugs that are driving the spread of disease. People here have primarily been injecting painkillers or, in some cases, non-opioids. But heroin — which emerged in Louisville, Lexington, and northern Kentucky four or five years ago — has started popping up recently in rural eastern Kentucky, posing new health problems.
“If people have been abusing prescription pills, that’s a known quantity,” said Van Ingram, executive director of the Kentucky Office of Drug Control Policy. “With heroin and fentanyl-laced heroin and fentanyl disguised as heroin, it makes people very susceptible to overdoses.”
The concentration of hepatitis C cases among young adults poses another problem: In roughly 6 percent of pregnancies, the virus is passed from mother to child. This summer, state and federal health officials reported that the infection rate in Kentucky women of childbearing age increased more than 200 percent from 2011 to 2014 and that the proportion of infants born to infected mothers rose 124 percent.
“We have seen an outrageous number of babies who are exposed,” said Dr. Claudia Espinosa, a pediatric infectious disease expert at the University of Louisville. She said she and colleagues track about 100 babies a year with potential exposure compared to a few dozen in prior years.
At the University of Kentucky, doctors saw 13 babies born to mothers with hepatitis C in 2010, said Dr. Sean McTigue, a pediatric infectious disease expert. In 2015, it was 65 babies, and through August of this year, they had already seen 61 babies.
“It doesn’t really seem to be leveling off,” McTigue said.
Now, Kentucky is the only state in the country to require clinicians to report cases of infected pregnant women to the state.
None of the new medications are approved for children, although clinical trials are underway. Officials also fear that children could spread the virus.
“They bite, they scrape their knees, they lose their teeth,” said Kathy Sanders, Kentucky’s hepatitis C program coordinator. “We’re worried about potential exposures to day care workers and teachers and classmates.”
As health officials struggle to treat hepatitis C cases, others here are hoping that they can get better at preventing them in the first place.
Jennifer Havens, an epidemiologist at the University of Kentucky, has been tracking hundreds of drug users in Perry County since 2008. Along with the help of local interviewers, she has detailed what drugs they use, with whom they use drugs, and if they can get substance abuse and medical treatment.
Their research, as well as work done in Austin, Ind., suggests it is possible to track how diseases like HIV and hepatitis C spread through close networks of drug users and to pinpoint the people most likely to infect others. That raises the possibility that one day health officials will be able to focus treating the hepatitis C patients who are most at risk of infecting others as a form of prevention.
“We could potentially find people who are injecting with the highest number of partners, those who are injecting regularly, those who are injecting with dirty syringes,” Havens said.
It may not be realistic at this point, she said, but “there’s got to be a way to come up with a formula in the future to find out who would be best to treat in a limited resource setting.”