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Harvoni® (ledipasvir and sofosbuvir) and Hepatitis C

What is Harvoni®?

harvoniOn October 10, 2014 the U.S. Food and Drug Administration approved the prescription medication Harvoni® (ledipasvir and sofosbuvir) as a fixed-dose tablet combining ledipasvir, an HCV NSA5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, for the treatment of adults with chronic Hepatitis C genotype 1 infection.

The active ingredients of this tablet include 90 mg ledipasvir and 400 mg sofosbuvir.

Gilead Sciences, Inc., the U.S. manufacturer of Harvoni recently announced that their newly created subsidiary, Asegua Therapeutics LLC will be producing a generic form of this prescription medication that will be available in January 2019.

Last Updated: December 2018

"FDA Drug Safety Communication: FDA Warns of Serious Slowing of the Heart Rate When Antiarrhythmic Drug Amiodarone is Used with Hepatitis C Treatments Containing Sofosbuvir (Harvoni) or Sovaldi in Combination with Another Direct Acting Antiviral Drug." U.S. Food and Drug Administration, Retrieved April 10, 2015.

"Full Prescribing Information." Gilead Sciences, Inc., Retrieved April 10, 2015.

"Harvoni® Coupon and Savings." Gilead Sciences, Inc., Retrieved April 13, 2015.

"Patient Information: Harvoni®." Gilead Sciences, Inc., Retrieved April 13, 2015.

"Support Path Harvoni® and Sovaldi® Tablets Treatment Support." Gilead Sciences, Inc., Retrieved April 13, 2015.