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Gilead’s Harvoni Approved for New Indications

Once-daily breakthrough therapy expanded for use in genotype 4, 5 and 6 chronic HCV

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By: Kristin Brooks

Managing Editor, Contract Pharma

Gilead Sciences has received approval from the FDA for Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. Also, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received approval for chronic HCV genotype 1 infection in the U.S. in October 2014.
 
The approval was supported by data from two trials 1119 and ELECTRON-2. Study 1119 evaluated Harvoni for 12 weeks in patients with HCV genotype 4 or 5 who were treatment-naïve and treatment-experienced with or without cirrhosis. Results showed that 93% (41/44) of those with genotype 4 and 93% (38/41) of those with genotype 5 achieved SVR12. ELECTRON-2 evaluated Harvoni for 12 weeks in treatment-naïve or previously-treated patients with genotype 6 HCV infection with or without cirrhosis. In this study, 96% (24/25) of patients achieved SVR12.
 
The most common adverse events were asthenia, headache and fatigue.

Worldwide Harvoni sales were $10.5 billion nine months ended Sept. 30, 2015 and is significantly outpacing all other competion currently on the market.

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