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FDA Approves Harvoni for Expanded Use

On Thursday, Gilead Sciences announced that the FDA has approved expanded use of the hepatitis C treatment Harvoni. Harvonis can now be used to treat patients who have chronic hepatitis C infection genotypes 4, 5 and 6 , as well as patients who are co-infected with HIV.

In addition, the FDA approved a combination therapy of Harvoni plus ribavirin for 12 weeks as an alternate therapy to Harvoni treatment for 24 weeks in treatment-experienced, patients with genotype 1 who also have cirrhosis.

Study results showed that about 93% of the patients with these subtypes of the virus and 96% of patients co-infected with HIV showed a sustained response to the virus within 12 weeks of treatment.

Harvoni was first approved for the treatment of chronic HCV genotype 1 infection in adults in the US in October 2014.1-2

  1. RTT News. Gilead's Hepatitis C Drug Approved For Expanded Use. NASDAQ. November 12, 2015. Available at: http://www.nasdaq.com/article/gileads-hepatitis-c-drug-approved-for-expanded-use-20151112-01519#/ixzz3rL6kNVin
  2. U.S. FDA approves Gilead's hepatitis C drug for expanded use. Reuters, Health. November 12, 2015. Available at: http://uk.reuters.com/article/2015/11/12/us-gilead-sciences-fda-idUKKCN0T12UA20151112

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