FDA OKs First Combo Drug (Harvoni) for Hepatitis C


October 10, 2014

The US Food and Drug Administration (FDA) today approved a new antiviral drug to treat chronic hepatitis C virus (HCV) genotype 1 infections that lays claim to two "firsts," the agency announced today.

Ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) is the first combination drug for HCV as well as the first treatment that does not require administration with interferon and ribavirin, according to the FDA.

The novel drug comes with controversy. The previously approved sofosbuvir component (Sovaldi, Gilead Sciences) is one of the nation's most expensive drugs, costing $84,000 for a 12-week course of treatment, or about $1000 per pill. Gregg Alton, the manufacturer's executive vice president of corporate and medical affairs, told Reuters that the company will charge even more for the combination drug. Alton did not specify the price, but he said it would reflect the $95,000 cost of treating someone with sofosbuvir along with interferon and ribavirin, which will no longer be needed, according to Reuters.

The other component of the combo drug, ledipasvir, has never been approved until now.

Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said the new drug changes the "treatment paradigm" for patients with HCV.

"Until last year, the only available treatments for [HCV] required administration with interferon and ribavirin," Dr Cox said in a news release. "Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens."

The FDA based its approval of ledipasvir/sofosbuvir on three clinical trials in which 1518 participants with HCV were randomly assigned to receive the new combo drug with or without ribavirin. The first trial focused on participants who had never been treated for their infection; the second on the same kind of participants, but some with cirrhosis; and the third on participants, again, some with cirrhosis, who had not responded to previous treatment. In each trial, more than 90% of participants taking the new combination drug achieved sustained virologic response, meaning HCV was no longer detectable in their bloodstream, by 12 weeks. In the first trial, 94% of treatment-naive participants reached sustained virologic response in 8 weeks, yielding a faster cure that will reduce treatment cost, according to Gilead Sciences.

"In all trials, ribavirin did not increase response rates in the participants," the FDA stated.

Fatigue and headache were the most common adverse events.

Last month the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval of ledipasvir/sofosbuvir in the European Union.

More information about today's FDA announcement is available on the agency's website.


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