Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved 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. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.

The supplemental new drug application (sNDA) approval for HCV genotypes 4, 5, and 6 was supported by data from the open-label 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 sNDA approval for patients with HCV/HIV-1 co-infection was supported by data from the Phase 3 open-label ION-4 study, which evaluated Harvoni for 12 weeks for the treatment of genotypes 1 or 4 chronic HCV infection among patients co-infected with HIV. Data demonstrate that 96% (321/335) of patients achieved SVR12. The study included HCV treatment-naïve (45%) and treatment-experienced (55%) patients, including patients with compensated cirrhosis (20%). The majority of patients were taking one of three HIV antiretroviral regimens: tenofovir disoproxil fumarate and emtricitabine with efavirenz, raltegravir or rilpivirine.

The sNDA approval of Harvoni with ribavirin for 12 weeks for genotype 1 treatment-experienced HCV patients with cirrhosis was supported by data from the Phase 2 SIRIUS study, which evaluated Harvoni plus ribavirin for 12 weeks or Harvoni without ribavirin for 24 weeks in genotype 1 HCV-infected patients with compensated cirrhosis who failed prior therapy. Ninety six percent (74/77) of patients treated with Harvoni plus ribavirin for 12 weeks, and 97% (75/77) of patients treated with Harvoni for 24 weeks without ribavirin, achieved SVR12.

Harvoni previously received FDA approval for the treatment of chronic HCV genotype 1 infection in adults in October 2014.

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