FDA Expands Label of Gilead’s Harvoni

November 19, 2015

The FDA has expanded the label of Gilead Sciences’ Harvoni in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV.

Harvoni’s (ledipasvir/sofosbuvir) sNDA for genotypes 4, 5 and 6 was supported by clinical trials that showed 93 percent of those with genotype 4 achieved sustained viral response at 12 weeks (SVR12),  93 percent of those with genotype 5 achieved SVR12 and 96 percent of those with genotype 6 achieved SVR 12.

The sNDA for patients co-infected with HIV was supported by data that showed 96 percent of patients with genotypes 1 and 4 HCV infection achieved SVR12. The majority of patients were taking one of three HIV antiretroviral regimens.

The agency also approved Harvoni in combination with ribavirin for 12 weeks as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.

Harvoni was approved in October 2014 in the U.S. for the treatment of chronic HCV genotype 1 infection.