FDA Approves Drug That Can Cure Hepatitis C In Eight Weeks

Pharmaceutical company Gilead Sciences is promising that nearly half of patients infected with hepatitis C can be cured after eight weeks of taking its new drug, Harvoni.

Reuters has reported that the U.S. Food and Drug Administration (FDA) has approved Harvoni, the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.

According to the New York Times, patients will have to pay a hefty price for the wonder pill. With a suggested retail price of $84,000, Harvoni is an improvement upon Gilead’s existing blockbuster hepatitis C drug, Sovaldi, which has become the poster child for those complaining that the cost of medicines is out of control.

Harvoni will serve as a standalone treatment pill for hepatitis C, and will not have to be taken with interferon and ribavirin, as is the case with Sovaldi.

In a release on its website, Gilead’s Chairman and Chief Executive Officer Dr. John C. Martin affirmed the trustworthiness of the pill.

“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks. Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well tolerated. We are now working to ensure rapid and broad access to Harvoni.”

The Inquisitr previously reported on BIT255, an antiviral drug making similar claims about its ability to cure hepatitis C.

The release from Gilead noted that the FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.

Harvoni’s approval is supported by data from three Phase 3 studies which evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 patients with chronic hepatitis C.

Principal investigator in the Harvoni clinical trials, Professor of Medicine at Harvard Medical School Dr. Nezam Afdhal, asserted that the pill is a surefire way to fast track hepatitis C treatment.

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

Harvoni achieved cure rates of 94-99 percent after eight weeks of clinical trials.

[Image via Life Beyond Hepatitis C]