Harvoni Approved For The Treatment Of Chronic Hepatitis C, Genotype 1 Infection In Adults; Diplomat To Distribute

U.S. Food and Drug Administration (FDA) announced October 10, 2014 that Gilead Sciences Harvoni® (ledipasvir/sofosbuvir) product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Harvoni® is the first oral combination therapy approved for the treatment of hepatitis C and is also the first treatment regimen that does not require administration with pegylated interferon or ribavirin. Harvoni® is a once-daily, fixed-dose tablet that combines 90 mg of the NS5A inhibitor ledipasvir with 400 mg of the nucleotide analog polymerase inhibitor sofosbuvir. Sofosbuvir was approved by the FDA under the trade name Sovaldi® in December 2013. The duration of treatment with Harvoni® is eight, 12 or 24 weeks, depending on the patient's prior treatment history, cirrhosis status and baseline viral load. Harvoni's® efficacy has been established in patients with chronic hepatitis C in three Phase 3 studies: ION-1, ION-2 and ION-3. Hepatitis C is a viral disease that causes inflammation of the liver, which can lead to diminished liver function or liver failure. Some individuals with chronic hepatitis C infection may develop cirrhosis, in which liver tissue is replaced by scar tissue, eventually preventing the liver from functioning properly. According to the Centers for Disease Control and Prevention, approximately 3.2 million Americans are infected with hepatitis C. Unlike other serious or chronic diseases, hepatitis C can be cured with treatment. Harvoni® was granted priority review and breakthrough therapy designation by the FDA as a medicine with the potential to offer major advances in treatment over available therapies. Harvoni® is a product of Gilead Sciences, based in Foster City, California. Harvoni will be broadly distributed at pharmacies throughout the country and will be continually stocked at Diplomat. For full prescribing information, please visit the manufacturer's website: http://www.gilead.com/medicines.