Harvoni Approved to Treat More HCV Patient Populations

Harvoni Approved to Treat More HCV Patient Populations
Harvoni Approved to Treat More HCV Patient Populations

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.

For more information visit Gilead.com.

Loading links....