FDA Approves New Combo Rx for Hepatitis C

Harvoni is the first combination treatment for chronic hepatitis C

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) US regulators have approved a new pill to treat hepatitis C. That pill, which is a combination of two medications, could simplify treatment for patients.

On Friday, the US Food and Drug Administration (FDA) approved Harvoni (ledipasvir and sofosbuvir) to treat people with chronic hepatitis C.

According to an FDA press release, Harvoni is the first complete treatment for hepatitis C. That is, it's the first approved treatment that doesn't require patients to also take interferon or ribavirin — two FDA-approved medications also used to treat hepatitis C.

Harvoni is also the first combination pill for hepatitis C.

"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, director of the FDA's Office of Antimicrobial Products, in the FDA press release.

"Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin," Dr. Cox said. "Now, patients and health care professionals have multiple treatment options, including a combination pill to help identify treatment regimens."

Hepatitis C is a contagious liver disease caused by the hepatitis C virus. This virus is mainly spread through contact with the blood of an infected person.

Chronic hepatitis C is a long-term illness that can lead to serious liver problems like cirrhosis (scarring of the liver) or liver cancer. The Centers for Disease Control and Prevention (CDC) reports that about 3.2 million people in the US have chronic hepatitis C. Most of these people, the CDC says, do not know they are infected.

Harvoni's approval comes after three clinical trials testing the medication. Those trials comprised 1,518 hepatitis C patients who had never before received treatment or who had not responded to past treatments. The patients received Harvoni with or without ribavirin.

At least 12 weeks after the patients finished treatment, researchers tested whether they could detect the hepatitis C virus in the patients' blood. If they could not detect the virus, then the patient was said to have reached "sustained virologic response," or SVR. SVR basically means that they have been "cured" of the virus.

In all three trials, at least 94 percent of patients, and as much as 99 percent, achieved SVR.

Ribavirin did not improve response rates in any of the trials.

Fatigue and headache were the most common side effects of Harvoni in these trials.

Harvoni is developed by Gilead Sciences, which also markets sofosbuvir under the brand name Sovaldi. Sovaldi is also approved by the FDA to treat hepatitis C.

According to The New York Times, Harvoni may be less expensive than treatment with Sovaldi, which requires patients to take additional medications at an additional cost.

The New York Times reports that Sovaldi costs about $1,000 per pill, or about $84,000 for the typical 12 weeks of treatment. Although 12 weeks of Harvoni will have a price tag of $94,500, that amount is about on par with the cost of Sovaldi plus the other medications used with it. Some patients will be able to take Harvoni for only eight weeks, which will cost about $63,000.


Review Date: 
October 10, 2014
Last Updated:
October 13, 2014