The True Meaning of a Cure | Page 2

BY DAVY JAMES, MANAGING EDITOR
New hepatitis C drugs moved the dream of a cure into a reality that gives patients a new chance at life.
PUBLISHED WEDNESDAY, JUNE 10, 2015
“I had such a horrible experience the first time I took it because nobody told me about the side effects,” he said. “After I gave myself that first shot, I went to go see a movie and I started getting chills and a fever. I really thought I was going to die that night because nobody told me anything about what to expect. When I woke up I thought, ‘My God, I lived to see the next day.’ I called my doctor and he said, ‘Oh yeah, that was just part of the side effects.’ I said, ‘Oh great, thanks for telling me.’”

The psychological side effects from the treatment caused Franciscus to go on antidepressants. He would also develop long-term insomnia for which he still takes sleep medication.

“Had I known I only had a 9% chance of achieving an SVR on that treatment, I never would’ve taken it,” he added.

O’Hara also faced similar difficulties when she began treatment. She started therapy with pegylated interferon, but had to cease treatment five months in after she became anemic. A year-and-a-half later, O’Hara began taking interferon monotherapy, but instead of taking it three times a week, she was prescribed the drug daily.

“I said to my doctor, ‘If I didn’t know better, I’d think you were trying to kill me,’” she recalled. “It was that bad. I lost a lot of hair. I was sick all the time. I don’t know how I made it into work, but I made it most of the time.”

Franciscus was ultimately one of the lucky ones. He would be treated three times over 10 years, first receiving interferon monotherapy. Failing there, he then went on a high daily dose of interferon. Failing there, he began a grueling regimen with pegylated interferon and ribavirin for 70 weeks.

“There were a lot of side effects, and it really exacerbated the symptoms you have with hepatitis C,” he said of the drug regimen. “You have joint pain, muscle pain, and I got a serious rash on my legs from ribavirin. I was getting migraines, itching—basically any side effect you could have on that therapy, I was having.”

Franciscus persevered, however, and at the end of the treatment cycle he defied the odds and cleared the virus.

“Being cured of hepatitis C is talked about now, but it really wasn’t talked about then,” he said. “Being cured of the virus also really cured a lot of the symptoms. The fatigue, the mental confusion, the aches and pains, and all the skin stuff. It was really great.”

Other HCV patients like O’Hara who were unable to clear the virus with the older standard drugs weren’t so lucky. “I was feeling very hopeless. I thought, ‘My God, this is going to kill me.’ That’s the feeling,” she said. “So I swore at that point to just live the healthiest life I could.”

Hope on the Horizon

While millions of patients who saw little improvement with the standard HCV drugs continued living with a silent killer lurking inside them, hope appeared in the form of a significant experimental drug in the pipeline. A New Drug Application was submitted by Gilead Sciences for Sovaldi in April 2013, which was granted Breakthrough Therapy Designation by the FDA before being approved in December 2013.

“I would search for hours on the Internet to try and find new drugs, but you read the release and think, ‘OK, but what’s the real story with these drugs, because they always sound too good to be true,’” Franciscus said. “But then with Sovaldi, we started hearing from patients that these drugs are easier to tolerate, and then you start to hear these drugs are reaching cure rates that are approximating the clinical trial results. So, when Sovaldi was approved by the FDA, I was really hopeful, and [during] the last couple of years the results of the drug have been really amazing.”

With its $1,000-per-pill price tag, a debate soon stormed over Sovaldi as patients lined up to try and obtain access to the treatment. Walgreens senior director of virology Glen Pietrandoni noted that the cost of the new, highly effective HCV drugs has to be evaluated within the big picture of the cost for long-term treatment.

“You have to consider the cost of liver disease, transplantation, and possibly cancer down the road with cirrhotic patients,” he said. “All those things really do come into play when you look at overall savings.”

O’Hara began a 24-week regimen with Sovaldi late last year and has already seen significant progress. Her viral load dropped from 10 million to less than 15 after 8 weeks of therapy.

“It’s amazing to me the difference in the medications in terms of side effects and the ease of taking it,” she said. “It’s one pill, once a day. For the first two weeks I had slight headaches and trouble focusing my vision, but after that, I haven’t had any side effects whatsoever. It’s like a miracle.”

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