FDA Approves Gilead's New Hepatitis C Drug Harvoni

Published: Oct 15, 2014

FDA Approves Gilead Sciences, Inc.'s New Hepatitis C Drug Harvoni

October 13, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration (FDA) has approved the first once-a-day pill for the treatment of hepatitis C, the company that makes the drug, Harvoni, said this week.

Gilead Sciences announced Friday, October 10, that the pill, which is a cocktail of ledipasvir and sofosbuvir (known under the brand name Sovaldi), has been cleared for use in the main subtype of hepatitis, called genotype 1, which accounts for more than two-thirds of the nation’s cases.

Gilead has had high hopes for Harvoni, after clinical trials found that over 90 percent of the patients treated with the drug had no detectable virus in their blood three months after treatment was ended. In medical parlance, that is effectively a cure.

“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” said Nezam Afdhal, director of hepatology at Beth Israel Deaconess Medical Center, professor of medicine at Harvard Medical School and a principal investigator in the Harvoni clinical trials, in a statement.

“For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks,” said Afdhal.

Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi in December 2013. Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load.

Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

The high costs of both drugs remain controversial, however. A 12-week course of Harvoni costs around $94,500, while a similar course of Sovaldi will run as much s $84,000. Those price tags have had insurers and public health plans like Medicaid balking at backing the treatment or offering reimbursement.

Still, the efficacy of the drug cannot be disputed, and Gilead told news outlets Friday that its pricing is reasonable.

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