Harvoni ledipasvir regulatory update

The European Commission approved Harvoni ledipasvir/sofosbuvir from Gilead to treat chronic HCV genotype 1, 3 and 4 infection. Gilead said the EC recommended Harvoni in courses of 12 or 24 weeks for both treatment-naive and treatment-experienced patients, with and without cirrhosis, and said 8-week treatment courses could be considered in non-cirrhotic, treatment-naive patients with HCV genotype 1 infection. The EC recommended 24-week courses in combination with ribavirin to treat HCV genotype 3 in patients with cirrhosis or for whom prior treatments have failed. It also recommended the drug in patients co-infected with HIV. ...