FDA: Harvoni Approved for Chronic Hepatitis C
Combination pill, taken once a day, blocks enzymes that virus needs to multiply
FRIDAY, Oct. 10, 2014 (HealthDay News) -- Harvoni, a daily pill that treats chronic hepatitis C virus (HCV) genotype 1 infection, was approved by the U.S. Food and Drug Administration on Friday.
It's the first combination pill (ledipasvir and sofosbuvir) approved to treat chronic HCV genotype 1 infection, and the first medication that doesn't require that the antiviral drugs interferon or ribavirin be taken at the same time, the FDA said in a news release. Both drugs in the combination pill interfere with the enzymes needed by HCV to multiply. One of the drugs, sofosbuvir (Sovaldi) was approved in December 2013.
"With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease," Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "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, including a combination pill to help simplify treatment regimens."
Harvoni was evaluated in three clinical studies involving 1,518 people who either hadn't been treated previously or hadn't responded to prior treatment. The most common side effects were fatigue and headache. However, price has been an issue with some of the new treatments for hepatitis C. For example, Sovaldi alone costs $1,000 a day and not all insurance companies cover the cost of treatment, experts have noted. Harvoni will cost $1,125 a pill, the Associated Press reported Friday.
The drug is marketed by Gilead, based in Foster City. Calif.