FDA Approves Gilead's Harvoni, Sovaldi/Ledipasvir Combination For HCV

The Food and Drug Administration (FDA) has approved Gilead’s Harvoni, a combination of sofosbuvir (brand name Sovaldi) and ledipasvir for hepatitis C (HCV) genotype 1. Gilead announced the approval in a press release, stating that the treatment consists of 90 mg of ledipasvir and 400 mg of sofosbuvir in a once-daily single tablet, the first combination drug approved by the FDA to treat chronic HCV genotype 1 infection.

Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products at the FDA, said, “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.”

Ledipasvir/Sofosbuvir

The FDA approved Sofosbuvir, a nucleotide analog polymerase inhibitor, in December 2013 to treat HCV. Ledipasvir is a new drug, an NS5A inhibitor. Both agents interfere with the enzymes HCV needs to multiply. For some treatment-naïve patients, effective treatment can be achieved in only eight weeks.

John C. Martin, PhD, Chairman and CEO of Gilead Sciences, said, “Unlike other serious chronic diseases, hepatitis C can be cured.” His comment echoes previous statements from Gilead emphasizing that sofosbuvir provides a cure, and is therefore worthy of the high cost that has caused a controversy. Medscape reports that the ledipasvir/sofosbuvir combination will cost even more than the $84,000 that Gilead charges for Sovaldi.

FDA Action

The FDA states in its press release that Harvoni is the third drug for HCV approved in the past year, including Sovaldi and Janssen’s Olysio (simeprevir). The FDA gave Harvoni priority review and designated it a breakthrough therapy. The federal agency based its approval on three clinical trials with 1,518 patients. The participants received Harvoni with ribavirin or Harvoni alone. Ribavirin did not increase response rates. The trials showed that 94 to 99 percent of patients achieved a sustained virologic response (SVR) at week 12 as the virus was no longer detected in the blood.

Gilead’s Regulatory Activities

Gilead announced in September that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), gave the ledipasvir/sofosbuvir regime a positive opinion. Also in September, Gilead submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for the approval of ledipasvir/sofosbuvir. Gilead has also moved to make low-cost versions of sofosbuvir available to developing countries.