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Gilead's (GILD) HCV Drug Harvoni's Label Expanded in U.S.

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Gilead Sciences, Inc.GILD announced a label expansion for its hepatitis C virus (HCV) infection drug, Harvoni, in the U.S. With the label expansion, Harvoni can now be used for the treatment of patients with chronic HCV genotypes 4, 5 and 6 infection and in patients co-infected with HIV. Additionally, Harvoni, in combination with ribavirin as a 12-week regimen, was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced genotype 1 patients with cirrhosis.

We remind investors that in the U.S., Harvoni is available for the treatment of chronic HCV genotype 1 infection in adults. We are encouraged by the label expansion of the drug. Harvoni is the key revenue driver at the company. However, Gilead's HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.'s ABBV Viekira Pak among others. Harvoni witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. In this scenario, the label expansion of Harvoni is a major win for the company. It should boost the drug's sales.

Meanwhile, competition in the HCV market is intensifying as several companies like Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.

Gilead currently carries a Zacks Rank #2 (Buy). Baxalta Incorporated BXLT is another well-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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