Expensive New Hep-C Drug from Gilead Approved By FDA

By John Lavitt 10/16/14

The new hep-C drug, Harvoni, will combine two medicines while costing a staggering amount of money for treatment.

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Gilead Sciences has won FDA approval for a new combination hepatitis C treatment drug called Harvoni. Harvoni is a combination of sofosbuvir, the active ingredient in Sovaldi, and a new medicine from Gilead called ledipasvir, which is not available as a stand-alone product.

The two drugs attack the virus in different ways. Although the new drug promises to cure most hepatitis C patients without requiring other medicines, the close to six-figure cost of the treatment will exacerbate tensions between the drug companies and the health insurers over spiraling prices.

The cost of the treatment is a staggering $94,500 for the most typical patients, who will be treated for 12 weeks. Still, the new single orange pill needs to be taken just once a day and will cure most patients. American citizens with hepatitis C who cannot convince their insurance carriers to cover the new treatment will certainly be angry to be placed in a dangerous holding pattern due to expense.

Gilead Sciences recorded the biggest drug launch in history with Sovaldi this past year, making the company a lightning rod for critics of drug prices. Sovaldi alone costs $84,000 for a typical course, but it must be combined with other therapies that have definite side effects. The new drug regimen has very limited side effects, particularly in comparison to past treatments for HCV like pegylated interferon and ribavirin. Wall Street analysts estimate the company racked up roughly $9 billion in sales since the launch earlier this year.

Tensions between insurers and pharmaceutical companies have risen as the drug makers have increased prices repeatedly and then priced new drugs higher than the older therapies. Steven Miller, chief medical officer at Express Scripts, a pharmacy-benefits manager, explained that, “If pharma continues to price based on what the market will bear, I promise you it’s not sustainable.”

To control costs, insurers have been trying to restrict the use of Sovaldi to sicker patients, keeping many out in the cold. Harvoni can be taken without the injections that Sovaldi is supposed to be taken with. The injections can cause bad side effects like depression, fatigue, and headaches. In clinical trials, Harvoni performed better than regimens containing Sovaldi, curing a slightly higher percentage of patients.

Donald Jensen, director of the University of Chicago’s Center for Liver Diseases, who has done clinical-trial research for Gilead and other pharmaceutical companies, expressed his excitement about the approval of Harvoni. “To get an even better cure rate without the injections and with therapy as short as eight to 12 weeks is clearly revolutionary,” he said.

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.