New FDA-Approved Hepatitis C Drug Treats Disease with Pills Instead of Needles

New FDA-Approved Hepatitis C Drug Treats Disease with Pills Instead of Needles
October 10, 2014

The U.S. Food and Drug Administration (FDA) approved the first combination pill to treat hepatitis C.

Harvoni is the first approved regimen that doesn't require administration with interferon or ribavirin, two other FDA-approved drugs that are used to treat hepatitis C.

According to a statement from the FDA, both drugs in Harvoni interfere with the enzymes needed by hepatitis C to multiply. Sofosbuvir is a previously approved drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

Harvoni is the third drug approved by the FDA in the past year to treat hepatitis C infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Harvoni and Sovaldi are both marketed by Gilead.

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

The Costs

While the drug comes in a convenient form and requires less treatment time than other regimes, it comes with a heavy price tag.

Forbes is reporting that a 12-week treatment will cost $94,500.

That's more than Gilead's Sovaldi, which comes in at $1,000 a pill, totaling $84,000 for a full treatment. In response to Solvaldi's high cost, 35 states require prior authorization before Medicaid patients can get the drug. In this case, prior authorization means a liver biopsy to determine the disease's severity.

Baby Boomers at Risk

About 3.2 million people are infected with hepatitis C, which is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Generally a quiet disease, most people infected with hepatitis C don't know they have it until their liver is already damaged. A simple blood test can detect the disease, but without proper treatment, 15-30 percent of people will go on to develop cirrhosis.

About 75 percent of those infected are baby boomers, who contracted the disease before the blood supply was tested for it.

Until recently, hepatitis C treatment included interferon-based injections that often made patients feel ill with flu-like symptoms. The treatment lasted up to a year and cured only 40 to 50 percent of patients. The new treatments have a much higher success rate and take less time.