The powerful new hepatitis C drug that sent Gilead Sciences Inc. (GILD)’s sales soaring last quarter is doing the same for the hopes of millions of patients.
Sandra Cabrera and Ted Tabor both suffered devastating damage from hepatitis C. After just weeks of taking Gilead’s Sovaldi, they feel much better and tests suggest the lethal virus is disappearing from their blood.
“This is only the third week and I am like almost completely cured,” said Cabrera, a 44-year-old from Newark, New Jersey, who had a liver transplant in 2012 due to hepatitis damage. “It is amazing.” Cabrera found out this year that the disease had come roaring back, putting her new liver at risk.
Cabrera’s doctor recommended Sovaldi -- which the company yesterday reported reaped $3.48 billion in second-quarter sales -- but met with resistance from her insurance company at first, she said. Priced at $1,000 a pill, the drug is drawing comparisons with the HIV treatment cocktails that turned AIDS from a death sentence into a chronic disease. One big difference this time: Sovaldi in combination with other drugs is a cure.
Like with AIDS almost two decades ago, patients’ tales may help broaden access to treatment, said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a San Francisco-based nonprofit organization. For now, worry about the drug’s high cost prevents some people from getting it, he said.
“The stronger the voice of patients, the sooner we will reach a solution to the problem and ensure that everyone with hepatitis C will be treated,” Clary said. “That is what we learned from HIV.” He is working with other advocacy groups on a petition demanding that payers and drugmakers come together to find a way to ensure better access.
Gilead is facing complaints from doctors, patients and insurers for the price it charges. One study from the University of Liverpool concluded that 12 weeks’ worth of Sovaldi could be manufactured for $136. The Foster City, California-based company charges $84,000.
“Ensuring patient access to Sovaldi has been a top priority,” John Martin, Gilead’s chief executive officer, said on a conference call yesterday after the earnings were released. The company has been “actively engaging with payers.”
Sovaldi has been prescribed to more than 80,000 patients in the U.S. and Europe so far, according to Gilead. The U.S. Centers for Disease Control and Prevention estimates that hepatitis C affects 2.7 million people in the U.S. At least 130 million have the virus worldwide, according to the World Health Organization.
Sovaldi’s second-quarter sales of $3.48 billion beat expectations of $3 billion, according to an average of 12 analysts’ estimates compiled by Bloomberg. The company also doubled its product sales forecast for the year, including the hepatitis drug for the first time.
Gilead’s stock has gained 52 percent in the past 12 months through yesterday, putting it among the best performers of the 10 biggest global drugmakers by market value.
Since first winning U.S. regulatory approval in December, Sovaldi has forced old-fashioned patient triage, kindling envy among healthier sufferers while leaving some of the sickest patients with the best healing prospects. For those who get it, it can bring a new lease on life.
“We have people breaking down in tears,” said Mitchell Shiffman, a doctor at the Liver Institute of Virginia. The patients often have been treated four or five times without success over 15 years “and now they’re cured,” he said. “It’s absolutely amazing. You just turn people’s lives around.”
Tabor, a retired Royal Philips NV (PHIA) executive living in Paris, received an e-mail from his doctor on July 4 with the good news: his blood no longer harbors any trace of the hepatitis virus that has been gnawing at his liver for years.
“I’m doing a happy dance,” Tabor said in a telephone interview from Paris. “The miracle meds worked.”
Tabor is receiving Sovaldi and the other medicine in his regimen, Bristol-Myers Squibb Co. (BMY)’s daclatasvir, under a special program approved by the French government in March for hepatitis patients with the most advanced disease.
He was diagnosed in 2012 after promising his wife he would go for a health checkup after turning 60. He hadn’t felt that anything was amiss.
“You can’t really tell whether it’s symptoms of an ongoing malady or whether you’re getting old,” he said. “Fatigue, joint pain, skin discoloration, it’s very subtle and occurs over a long time. People just don’t know they have it.”
When they find out, the damage is sometimes advanced. Hepatitis C slowly attacks the liver and over many years, it can lead to cirrhosis, liver cancer and liver failure.
Tabor, a veteran who worked as a battlefield medic in Vietnam, doesn’t know for certain how he was infected, but suspects it was when he and other soldiers were vaccinated with unsterilized air gun injectors.
Before starting on his most recent regimen, Tabor spent two years taking injections with an immune system-booster called interferon, combined with an older drug called ribavirin that stops the hepatitis virus from spreading in the body. The side effects of the cocktail can include fatigue, depression, insomnia and severe mood swings.
“I turned into a raving lunatic, and would scream at people on the street for no reason,” Tabor said. “They call it riba-rage. The slightest little thing will set you off.”
‘Plagues of Job’
He also tried some of the first drugs developed to target the hepatitis virus directly: Vertex Pharmaceuticals Inc. (VRTX)’s Incivek and Merck & Co. (MRK)’s Victrelis. Those pills boosted cure rates, but added yet more side effects.
“They’re all the plagues of Job rolled into one,” Tabor said. “I was covered in boils.”
For all that, they didn’t work. The virus persisted in Tabor’s liver until this month.
Tabor still has to take Sovaldi for another 12 weeks, and wait for another 12 before he’s officially considered cured. Cabrera, meantime, says she expects to stay on the drug for months until all traces of the virus are gone.
Cabrera, who grew up in a housing project in the Ironbound section of Newark, found out she was infected from a routine blood test in 2008. She doesn’t know how she got it.
A year later, Cabrera started getting unexplained symptoms including severe bloating in her legs, nosebleeds, dizziness, and internal bleeding. Doctors in Pennsylvania, where she was living at the time, misdiagnosed her with kidney disease, even as the symptoms gradually got worse and she had to quit her job working at a door factory, she said.
In 2011, after moving back to Newark, a primary care doctor finally connected her symptoms to liver problems from hepatitis. He sent her to a nearby emergency room and told her to refuse to leave until she was seen by a liver disease expert.
To her shock, the doctors there told her liver was failing and put her on the list for a transplant the morning after she arrived, she said. They also diagnosed her with liver cancer, she said.
For months, she slept with her mobile phone by her bed, ready to rush to the hospital whenever an organ became available. After three false alarms, she finally received a new liver in a 16-hour operation in January 2012 that left her with a scar all the way across her belly. The complications of the operation were so bad she was in and out of the hospital for a year.
After she found out early this year that the virus had returned, she was terrified she might have to get a second transplant -- especially after she got a letter from her insurer in late May saying it wouldn’t pay for Sovaldi.
After her doctors appealed, the insurer approved the drug in late June, she said.
Kristin Binns, a spokeswoman for WellPoint Inc. (WLP), which operates Cabrera’s Medicaid plan, said in an e-mail that the company was unable to approve the initial requests for coverage because it hadn’t received key clinical information. Her request was approved once the company received more information, she said.
Within days of starting on Sovaldi and a second drug, Cabrera felt more energetic than she had in years. In mid-July, she found out that levels of virus in her bloodstream had plummeted to almost nothing. She is thinking about going back to work part time after the treatment ends.
Getting the drugs “shouldn’t have been so hard,” said Cabrera. “It is a big relief because now I can go on with my life.”
To contact the editors responsible for this story: Phil Serafino at firstname.lastname@example.org Elyse Tanouye, Marthe Fourcade