Good news flowed in at Gilead Sciences (GILD) with the FDA approving the company’s Harvoni for treating patients affected with chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is a once-daily combination treatment of Gilead’s highly successful HCV drug Sovaldi (sofosbuvir 400 mg) and ledipasvir (a NS5A inhibitor 90 mg).

Following the FDA approval, Harvoni becomes the first single tablet regimen to treat HCV (genotype 1). The approval of the cocktail therapy eliminates the need for interferon or ribavirin administration, which are associated with serious side-effects. Moreover, the duration of the treatment comes down significantly.

Although the recommended duration of therapy in treatment naïve genotype 1 HCV patients with or without cirrhosis is 12 weeks, it can be shortened to 8 weeks in case of patients (without cirrhosis) with baseline HCV viral load below 6 million IU/mL. The FDA also cleared the drug in treatment experienced patients with cirrhosis (24 weeks) and without cirrhosis (12 weeks).

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The FDA approval, which was widely expected, was gained on the basis of encouraging data from three phase III studies (ION-1, ION-2 and ION-3). These studies evaluated Harvoni over 8, 12 or 24 weeks, with or without ribavirin, in nearly 2,000 patients suffering from genotype 1 chronic HCV with compensated liver disease.

According to media reports, Gilead has priced Harvoni at $94,500 for a 12-week period. We are positive on Harvoni’s approval. We expect the cocktail therapy to record strong sales given its advantages in simplifying HCV treatment.

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The European approval of the combination therapy is on track with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending its approval last month AbbVie (ABBV) is also looking to bring its all-oral HCV combination therapy into the market. If approved, the U.S. launch could take place later this year and the EU launch in the first quarter of 2015.

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