The Cost Of A Cure: New Drugs May Eradicate Hepatitis C But Are They Worth It?

 @ZoeMintzz.mintz@ibtimes.com
on April 11 2014 3:00 PM
pills
Two recently approved "miracle drugs" show potential to cure hepatitis C in about 90 percent of their targeted patients. They come with a hefty price tag that two patients reveal is small compared to the results they have achieved. Flickr

John DiFazio has been to war, fought fires and beat cancer – but his battle with hepatitis C has been the longest.

The 62-year-old Vietnam War veteran and retired firefighter has lived with the virus for more than two decades. With six unsuccessful treatments under his belt, he did not expect two tiny pills to cure him of the chronic disease. Known under the brand names of Sovaldi and Olysio, the new “miracle drugs” have been shown to cure about 90 percent of their targeted patients without producing any of the harsh side effects seen from older medications. They also carry a hefty price tag – roughly $150,000 for a 12-week course of treatment for the two drugs. The high cost has left some questioning whether curing hepatitis C is worth it.

“All my blood work is normal right now. I have never been normal for 20 years,” DiFazio told International Business Times on his second-to-last day of treatment on Sovaldi and Olysio. “I’m amazed. You really want to jump up for joy.”

Sovaldi and Olysio, which are known as sofosbuvir and simeprevir, respectively, are made by two pharmaceutical companies: Gilead Sciences Inc. (NASDAQ:GILD) and Janssen Therapeutics (NYSE:JNJ). Each blocks the hepatitis C virus from replicating. The pills, which were approved by the U.S. Food and Drug Administration in December, are administered orally and can be used combination with existing hepatitis C treatments to eradicate the virus. A 12-week regimen of Sovaldi has an estimated cost of $84,000 or $1,000 a day in the United States. Olysio can cost more than $66,000.

“Hepatitis C is a huge medical problem in the world and in the United States. About 1.6 percent of the U.S. population has it, and the treatment for hepatitis C has been difficult for many years,” Dr. William Carey, a liver doctor at the Cleveland Clinic who co-authored one of the seminal papers identifying the virus in 1992, told IBTimes. 

In the United States an estimated 3 million people are infected with the virus that attacks the liver and leads to liver failure, liver cancer and in some cases death. Since 70 to 80 percent of people infected do not have symptoms, the virus can go undetected for decades until liver damage appears on standard medical tests.

This was the case for DiFazio, whose liver enzymes appeared high on a regular blood test. This led to his hepatitis C diagnosis, which he attributed to his time served in the Vietnam War nearly 25 years earlier.

“I remember blood on me many times,” DiFazio said, recalling his experience as an 18-year-old combat medic suturing wounded soldiers and administering penicillin shots while dodging bullets on the field. He also questions an inoculation method used during the time – air gun injectors – where a single device would administer shots to soldiers standing in a line without any visible needle replacement each time.

Hepatitis C is contagious and is transmitted through contact with contaminated blood. Sharing needles during illegal drug use is one of the most common ways the virus has been known to spread. It is also the main reason why hepatitis C has a social stigma attached to it.

Paul Bolter witnessed this firsthand. The 49-year-old Boston man was diagnosed in 2001. At the time, he was 12 years sober after abusing alcohol and illegal drugs in his early 20s.

“I know how I got the virus; I know when I got it,” Bolter said, referring to a three-month period in his life when he experimented with illegal drugs. But Bolter doesn’t let himself become a victim to his former life.

“I don’t allow myself to feel less than or shamed or it’s my fault,” Bolter told IBT. “I don’t think that way. I just keep moving on.”

He worked as a hairdresser before entering the health care field. He began as a receptionist and later got the opportunity at 45 years old to earn his degree at the University of Massachusetts to become a substance abuse counselor. At the time of his diagnosis, Bolter had just accepted a job as a hepatitis C educator.

“For a minute I thought was really dirty,” Bolter said, describing his first thoughts when he learned of his infection. “I thought, ‘Who is going to want to love me? Who is going to want to hang with me?’ All those things have happened. People have loved me; people do hang with me because I didn’t turn it into an issue.”

Like most hep C patients, Bolter and DiFazio were initially treated with interferon – an injection containing a naturally occurring protein that is known to “interfere” with viral replication. Until 2001, when a treatment breakthrough occurred, the standard protocol for hepatitis C treatment was to give interferon injections three times a week for 48 weeks. For those with genotype 1of hepatitis C, the most common subtype of the virus in the United States, just 9 percent were rid of the disease six months after interferon treatment.

Today, thanks to medical advances, interferon is given once a week in combination with other drugs. But these treatments also yield relatively few outcomes where the virus is undetectable – ranging from 14 to 51 percent depending on the type of interferon.

Regardless, interferon is an experience that is best described by those who have taken it. The host of side effects includes flu-like symptoms, joint pain, low blood counts and depression that can persist throughout treatment, which is at least 24 weeks or longer.

“I wasn’t sleeping for weeks. I was like a zombie,” DiFazio said, recalling his experience on interferon. He battled depression that made him unrecognizable to those who knew him.

“I like to fish, and I didn’t take my boat out in two years. I didn’t want to look at it,” he said. “Life was so much different.”

Bolter can relate. He remembers his life taking both interferon and ribavirin – a drug approved by the FDA in 1998 that proved to work well in combination with interferon to treat hepatitis C. At the time, the two-drug combination was considered a breakthrough therapy even though just 29 percent of those with genotype 1 had undetectable viral levels after treatment. Ribavirin is still prescribed today in combination with Sovaldi and interferon.  

“I was so dehydrated that I was consuming about a gallon of water a day and I was putting out just as much,” Bolter said, describing a point in his life where he saw an ear, nose and throat specialist, a neurologist and a urologist just to treat the side effects from the drugs. “There were times I was taking 30 pills day,” he said, adding that there were additional lotions and creams he was prescribed for skin rashes and irritations. He says his skin color changed dramatically and to this day continues to have problems with fatigue and colitis as a result from his first treatment.

Bolter and DiFazio were dubbed "non-responders" after multiple therapies they tried over the years that did not eliminate the virus from their systems – until they were prescribed Sovaldi and Olysio.

“Out of all the years I’ve been on treatment I’ve never had a sustained virological response,” Bolter said, describing the numerous times over his 13-year bout with the illness where his viral loads would decrease only to spike weeks later. “Right now I’ve remained undetectable for the first time ever.”

For Dr. Michael Saag, the director of the Center for AIDS Research at the University of Alabama at Birmingham, the new drugs eliminate the need to use interferon altogether.

“I don’t plan on using interferon again unless I can help it,” he told IBT, pointing to the drug’s harsh side effects, toxicity and relative inefficacy.

The two new drugs are considered breakthroughs -- not only for their effectiveness but also their low chances of producing severe side effects -- but some have criticized their high cost as a major barrier to patients that need a cure.

Steven Miller, chief medical officer of Express Scripts, a pharmacy benefit manager based in St. Louis, says the high cost for Sovaldi will burden the U.S. health care system. According to his estimates, if every hepatitis C patient in the country was treated with Sovaldi the cost would exceed $300 billion -- more than the U.S. currently spends on all prescription drugs.

Dr. Hillel Tobias, a liver doctor at New York University Medical Center who treats DiFazio, sees the situation differently. He suggests the treatment be viewed in terms of a patient’s overall health, not the cost of the individual pills.

“When the actual cost of treating the HCV patients with the new meds is calculated again on cost per cure rather than cost per pill, we are way ahead by far,” Tobias told IBT, pointing to the number of patients that need to be retreated, hospitalized or transfused – all of which require multiple doctor visits that add up. “That is not counting all who are saved from a $250,000 liver transplant.”

A cure may also encourage untreated and undiagnosed hepatitis C patients to seek medical help that will result in major savings that will surpass the cost of the medications, Tobias added.  

For patients in the early stages of the infection, an option may be to wait until newer drugs are approved in the near future that could drive down the treatment cost, Saag said.

“For people without advanced fibrosis, I would just as soon wait for the next wave of drugs to come that can be used in combination with sofosbuvir or some other kind of way and move forward then,” he said. “There’s no kind of urgency to treatment for those who have early stage infection or very little fibrosis.”

Both pharmaceutical companies, Gilead Sciences and Janssen Therapeutics, offer extensive patient assistance programs for patients who need help funding their treatment. In some cases Sovaldi can cost as little as $5 or nothing to patients without insurance options. One Olysio program offers the drug at $25 a month for a total of $75 for the three-month treatment. Both DiFazio's and Bolter’s insurances covered the cost of their medications.

Tobias says he hasn’t seen one patient who needed the medication denied since it was released.

“If you have someone that needs it now, you have to go through some hoops, but typically we have been able to get the drug for patients,” Saag said about his experience prescribing the medication.

While a life without hepatitis C may be in sight for both men, it will take time to get used to.

“There’s a chance that this will actually cure me,” Bolter said. “It looks like the light is here, but I’m not convinced yet.”

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