Sallie Wickens’ life followed a death-defying narrative that traced the medical arc of hepatitis C:
A blood-transfusion infection after a car accident in 1959, when she was 5; a positive test for the virus when she was 30; 10 years of deteriorating health; a debilitating course of interferon drug treatments that didn’t work; a liver so damaged she needed a transplant. And then…
Last month her doctor, hepatologist Laura Alba, walked into an exam room at St. Luke’s Hospital and gave Wickens, 60, a big smile.
Six months after she finished taking a new drug called Sovaldi, along with an old antiviral, ribavirin, Wickens remains free of the virus.
Never miss a local story.
“You are cured,” Alba told her.
When Sovaldi hit the market in December 2013, it was welcomed as the first in a series of wonder drugs that would revolutionize treatment of hepatitis C, a chronic disease that can lead to cirrhosis and liver failure.
Earlier hepatitis C drugs had wretched side effects and offered at best a 50-50 shot at a cure. Sovaldi, when used in combination with other drugs, cures more than 90 percent of patients with relatively mild side effects.
By last summer, some medical researchers were predicting the new drugs could help turn hepatitis C into a rare disease by 2036.
But Sovaldi also became known as “the $1,000 pill,” with a list price of $84,000 for a three-month course of treatment. Adding other drugs, tests and a doctor’s care put the total cost of a cure at about $150,000. That’s roughly double what the previous course of treatment cost.
With an estimated 3.2 million Americans suffering chronic hepatitis C infections, the expense would be staggering. State Medicaid programs and commercial insurance plans quickly restricted Sovaldi to the sickest patients.
A year later, Sovaldi and other new hepatitis C drugs appear to be living up to their promises, while the anxieties about their prices are easing.
“This is one of the most exciting events in modern medicine,” said Emalie Huriaux, director of federal and state affairs for Project Inform, an advocacy group for people with hepatitis C and HIV.
Meanwhile, new hepatitis C drugs just as effective as Sovaldi have entered the market, setting off a price war. Insurers have been able to extract discounts from drug companies. That’s expected to cut the cost of these drugs by about $4 billion this year, according to Express Scripts, a St. Louis-based pharmacy benefits management company.
Sovaldi’s manufacturer, Gilead Sciences, said this week that discounts on its hepatitis C drugs would average 46 percent this year.
Many uninsured or underinsured patients are getting their medications at little or no cost through manufacturers’ assistance programs. Patient advocates say these programs have been generous, at least to doctors and patients with the savvy and persistence to get through the paperwork.
“Doctors have gone from spending their time managing the side effects of the old medications to doing paperwork to get the new ones,” Huriaux said.
At the University of Kansas Hospital, liver specialist Richard Gilroy is constantly running interference for his hepatitis C patients. Just last month, an insurance company asked him to try the old hepatitis C therapy, the antiviral drug interferon, first.
“They wanted me to fail him on interferon before they would approve the standard of care,” Gilroy said. “The side effects of interferon can even be life-threatening.”
The Kansas City CARE Clinic, which treats many uninsured and low-income patients, has been able to circumvent the hurdles of Medicaid and commercial insurance plans by going through patient assistance programs. Much of the paperwork is handled by Albers Medical Pharmacy, a local independent pharmacy.
“I think we’ve had almost 100 percent success in obtaining medications for patients, regardless of their insurance,” clinic physician Blair Thedinger said.
Hepatitis C is part of an alphabetic list of distinct viral diseases that inflame the liver. Hepatitis A and B usually go away on their own, and there’s a vaccine that protects against them.
Hepatitis C can be far more dangerous and insidious. The virus usually is spread when an infected person’s blood enters the body of someone who isn’t infected. This commonly happens when intravenous drug users share needles. Risky sexual practices also may pass the virus. But some people, such as Wickens, acquired the infection from blood transfusions before tests excluded infected donors.
Hepatitis C is most common in the baby boom generation, and a government task force recommended in 2013 that everyone born between 1945 and 1965 be tested for the virus. Even though new hepatitis cases are declining, many boomers have long-smoldering chronic infections.
Until just a few years ago, the only treatment was injections of interferon in combination with other antiviral drugs. Practically all patients suffered severe side effects that included flulike symptoms, diarrhea and nausea, depression and anxiety. Many quit taking the drugs.
Two drugs introduced in 2011, Incivek and Victrelis, bumped up the odds of a cure to nearly 80 percent. But the drugs also more than doubled treatment costs and still had to be taken with interferon.
Many doctors, like Gilroy at KU Hospital, knew a third generation of hepatitis C drugs would soon be available and advised their patients to wait.
“Basically, we were warehousing patients,” Gilroy said.
When Sovaldi was introduced, it immediately became the drug of choice. But it comes at an even steeper cost than any of the drugs it replaced.
In a position statement, Gilead Sciences has said that pricing of its hepatitis C treatments “reflects the significant clinical, economic and public health value of these drugs, and is comparable to, or in many cases less than, the cost of older, less effective regimens.”
The drugs are also cost effective over the long term, Gilead said. The quick cure they provide “may lessen the frequency of healthcare visits and hospitalizations, and lower the need for medications to manage side effects and complications.”
Such explanations did not persuade Steve Miller, chief medical officer of Express Scripts and a leading critic of Gilead’s pricing.
Second-generation hepatitis C drugs already were priced at a premium, he said. Gilead was charging a premium over the second-generation prices for Sovaldi.
“We believe you shouldn’t take a premium on a premium,” Miller said.
In December, AbbVie introduced a competitor drug called Viekira Pak. Days later, Express Scripts announced it had made a deal with AbbVie for a discount on its new drug. In return, Viekira Pak would become the exclusive option for most hepatitis C patients covered by the Express Scripts National Preferred Formulary. The formulary covers about 25 million people.
Aetna, the nation’s third largest insurer, then negotiated a discount with Gilead. The deal includes both Sovaldi and Gilead’s newest hepatitis C drug, Harvoni, which combines Sovaldi with a second drug for a one-pill-per-day treatment.
And last week, Missouri announced that it was part of a 25-state consortium that has struck a deal with AbbVie to make Viekira its preferred choice for treating Medicaid patients. Missouri estimated this would save about $4.2 million in fiscal 2016.
The price war could continue. Merck has said it is planning to seek approval for its own Sovaldi competitor, possibly this year.
Wickens’ first treatment for hepatitis C, in 2007, proved unbearable.
The Climax Springs, Mo., woman sailed through treatment — interferon and ribavirin — until the fourth month, when the side effects kicked in.
“It was making me crazy,” she said. “I was having horrible hallucinations, seeing guns pointed at my head. I was hearing voices.”
Treatment was stopped. The drugs also caused her hair to fall out, but the virus survived.
By 2012, Wickens’ liver was failing. After four months on the transplant list, she received a liver graft.
But transplants don’t eradicate the virus, and last year her doctors at St. Luke’s told her she was ready for the new treatment. Her insurance covered the cost. Side effects were a minor rash and fatigue.
Six months after the treatment, her viral load remained undetected.
Even now, Wickens’ liver must be monitored, and she’ll continue to need medication to keep her body from rejecting it. But her liver won’t be battling hepatitis C, and in what seems like a miracle to her, neither will she.
“That hammer isn’t hanging over my head,” she said. “The reason I’m interested in telling the story goes back to when I was 5 years old, riding in the back seat of my mother’s car. The focus now must be on getting everybody tested.”
St. Luke’s Hospital (Plaza) offers free screening to the community. Go to www.saintlukeshealthsystem.org/hepatitis-c-screening or call 816-932-5483.
‘Chance for a new life’
Sovaldi came as a godsend to Lesia McWilliams, 49, of Independence, a patient at the Kansas City CARE Clinic.
Infected years ago with hepatitis C, she was slowly dying as the virus destroyed her liver.
But now, just eight weeks after she started taking a daily dose of Sovaldi and another new hepatitis C drug, Olysio, her bloodstream contains no trace of the virus.
“I know what that means for me,” McWilliams said. “That means I have a chance for a new life.”
Alan Bavley, firstname.lastname@example.org