FDA Approves Hepatitis C Combo Drug

The US Food and Drug Administration (FDA) on Oct. 10 approved a new drug combining ledipasvir and sofosbuvir (Harvoni/Gilead) as a treatment for chronic hepatitis C virus (HCV) infection.

The approval is the third drug approved for chronic HCV in the past year. The others are simeprevir (Olysio/Janssen) and sofosbuvir (Sovaldi/Gilead).

“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, MD, MPH, in a news release. Cox is 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, including a combination pill to help simplify treatment regimens.”

The drugs in Harvoni interfere with the enzymes the virus needs to multiply.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 patients who were treatment naive or who had not responded to previous treatment. That including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment, indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for 8 weeks and 96 percent of those who received Harvoni for 12 weeks showed a sustained virologic response (SVR). The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

FDA designated the drug as a breakthrough therapy, making it the seventh new drug approved in that category.

Harvoni is expected to overtake Solvaldi as standard care for hepatitis C patients.

The new drugs all come with controversy because of their prices.

Gilead is based in Foster City, CA and Janssen is in Raritan, NJ.