Harvoni Takes the Sting Out of Hepatitis C Treatment

Finally, there’s a medication to cure hepatitis C that doesn’t require use of the dreaded drugs interferon or ribavirin.

The U.S. Food and Drug Administration earlier this month approved Harvoni, a once-daily tablet manufactured by Gilead Sciences. Harvoni is a combination medication that includes sofosbuvir (Sovaldi), another Gilead breakthrough treatment approved late last year, and ledipasvir, which is also made by Gilead.

The new medication costs $95,000 for a 12-week course of treatment. On the surface it appears even more expensive than Sovaldi, which costs $84,000 for a 12-week supply. Both medications have been proven to cure hepatitis C in a majority of people with genotype 1 hepatitis C within that time frame.

But Sovaldi cannot be used alone, said Dr. David Bernstein, chief of hepatology and the Center for Liver Disease at North Shore-LIJ Health System and a fellow of the American College of Gastroenterology. Sovaldi was highly celebrated upon its approval last December for curing most people with genotype 1 with far fewer side effects than the use of ribavirin and interferon alone. However, it still had to be used with either those mainstays or another new drug called Olysio.

Prior to Sovaldi and other recently approved drugs, interferon-ribavirin cure rates were about 50 percent or lower. Many patients complained that the side effects — including nausea, diarrhea, itchy skin rashes, insomnia, and severe depression — were worse than the disease itself.

Harvoni is much less expensive than using Sovaldi with Olysio, Bernstein told Healthline. It is also about the same price as using Sovaldi with interferon and ribavirin.

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Be Ready to Rip Through Red Tape

While the same access issues have arisen with Harvoni as with Sovaldi — pharmacy benefit managers and Medicaid programs telling patients they’re not sick enough for the medication — they don’t appear to be any worse, Bernstein told Healthline.

“It takes time for things to be processed by any carrier,” he said, adding that some patients currently complaining of delays simply need to get through the approval process.

Yet he joined the chorus of gastroenterologists, hepatologists, and infectious disease doctors who have expressed dismay about patients being told they must try less expensive and less effective medications first. “You’re not going to wait for a diabetic to develop eye or kidney problems,” he said. “Why wait until cirrhosis? It’s just a cost issue.”

Hepatitis C is spread mainly by blood-to-blood contact. Injection drug users, people who snort drugs and share straws or rolled dollar bills, and men who have sex with men are at risk.

However, the disease can also be spread in tattoo and piercing parlors that do not use proper sterilization techniques. Prior to HIV and AIDS, sterilization procedures in hospitals and other healthcare settings were not as stringent as they are now.

The disease could also have been spread via blood transfusions, as it was not even identified until 1989. For all of the above risk factors, baby boomers have been designated as especially at risk. The U.S. Centers for Disease Control and Prevention (CDC) has called for all people born between 1945 and 1965 to be tested for the virus. The CDC estimates that more than 3 million Americans have the disease, and most don’t know they have it. Hepatitis C can linger for decades before presenting symptoms such as jaundice and fatigue. If left untreated, it can cause cirrhosis, or scarring of the liver, and eventually death.

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Old Treatments Worse than Disease Itself

Military veteran John Shutts, 56, fits the bill as an American at risk for hepatitis C. A baby boomer, he tested positive more than 12 years ago after spotting yellow streaks in his eyes and experiencing chronic fatigue. Veterans in general have been identified as at higher risk than most people.

Shutts underwent the standard pre-Sovaldi treatment, interferon and ribavirin, but found it unbearable and asked his doctor to stop after 14 months. “I told them, ‘This is enough,'” he said. Although treatment had reduced his viral load to 500,000, it has now rebounded to 7 million, he said.

The disease caused him to lose his management position working for the Transportation Security Administration at the airport in Corpus Christi, Texas, Shutts said. Now he works in a parts warehouse for far less money. He said the work is menial and not satisfying, and he misses being a manager.

He was denied access to Harvoni earlier this week but has filed an appeal. “I have good health insurance with the federal government,” Shutts told Healthline. “I have been working for over 40 years. I deserve better than this. All of this doesn’t make sense to me. I want to be cured and start a fresh life. My family and myself deserve this.”

Many patients in online patient communities for people with hepatitis C have already reported success obtaining Harvoni and have said they received a considerable amount of assistance, both financial and with obtaining approvals, through Gilead’s assistance program.

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