Gilead Wins U.S. Approval for Hepatitis C Combo Pill

Gilead Sciences Inc. won U.S. approval for the first all-oral hepatitis C drug for the majority of people infected with the virus, potentially marking an end to injections as a mainstay of treatment.

The Food and Drug Administration cleared Gilead’s once-daily medicine that combines the active ingredient in the Foster City, California-based company’s Sovaldi with a drug called ledipasvir, the agency said yesterday in a statement. The therapy was studied for its ability to cure patients in 12 weeks, four times faster than older treatments, and some can be treated in eight weeks, Gilead said in a statement. It will cost $94,500 for a typical 12-week treatment.

The FDA approved the pill, which Gilead will call Harvoni, for patients with genotype 1 hepatitis C, the most common form that infects about 75 percent of people with the virus. Drugmakers are competing to develop hepatitis C therapies that don’t require the use of interferon injections that can cause flu-like symptoms. Gilead’s Harvoni is the first that can treat the vast majority of patients without injections or another standard therapy called ribavirin, the FDA said.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options.”

Liver Damage

About 3.2 million people in the U.S. have hepatitis C, according to the Centers for Disease Control and Prevention. The virus attacks the liver and can lead to cirrhosis or cancer. Both active ingredients in Gilead’s new pill inhibit the ability of the virus to replicate.

The FDA in November approved Olysio from Johnson & Johnson and Medivir AB. The therapy requires interferon injections though it works in 24 weeks, cutting interferon shots in half compared with older treatments that are given for 48 weeks.

The FDA approved Gilead’s Sovaldi in December as an all-oral treatment for some patients and for genotypes 1 and 4 as part of a cocktail including interferon injections and ribavirin. The cocktail cured 90 percent of patients in a clinical trial in 12 weeks that hadn’t been treated before.

Price Criticized

Sovaldi’s $84,000 price tag for a 12-week course of treatment has attracted the ire of insurance companies and lawmakers who claim the cost makes the drug inaccessible for many who need it. For as many as half of genotype 1 patients who may benefit after just eight weeks of therapy, a Harvoni regimen will cost $63,000, Gilead said in an e-mail.

The $94,500 price for 12 weeks of treatment is about $200 less than the cost of Sovaldi, interferon and ribavirin together. America’s Health Insurance Plans, the lobby group for insurers, criticized the pricing.

“Gilead had an opportunity to demonstrate that it wants to be part of the affordability solution, but the company still seems to believe it has a blank check,” Brendan Buck, an AHIP spokesman, said in a statement. “Pricing like this drives up premiums for everyone, decimates public programs, threatens jobs, and most importantly, puts promising treatments -- like this one -- out of reach for many in our society.”

Gilead said it has programs to help patients with limited or no health insurance options access Harvoni.

Drug’s Value

“The price of Harvoni reflects the value of the medicine,” Gilead said. “Unlike long-term or indefinite treatments for other chronic diseases, Harvoni offers a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant health-care savings to the health-care system over the long-term.”

Gilead, the world’s biggest seller of HIV medicines, reported Sovaldi revenue of $5.75 billion in the first half of this year, according to data compiled by Bloomberg.

Olysio generated sales of about $1.2 billion during the same time period for New Brunswick, New Jersey-based J&J, the world’s biggest seller of health-care products.

Sovaldi prescriptions have declined since April, CVS Health Corp. said Sept. 17. The Woonsocket, Rhode Island-based company also found that 8.1 percent of patients stopped taking the pills before they finish the course, almost four times more than in Gilead’s clinical trials.

AbbVie Inc. and Enanta Pharmaceuticals Inc. are awaiting an FDA decision later this year on whether they can sell their hepatitis C treatment. J&J is seeking approval to sell Olysio in combination with Sovaldi and may learn the FDA’s decision in November.

The FDA designated Gilead’s combination pill as a breakthrough therapy, a status reserved for medicines for serious or life threatening conditions that affords a drugmaker additional access to agency reviewers to speed the drug to market.

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