Gilead's Harvoni gains European approval

The European Commission approved Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV genotype 1, 3 and 4 infection.

Gilead said the Commission recommended Harvoni in courses of 12 or 24 weeks for both treatment-naive and treatment-experienced patients, with and without cirrhosis, and said eight-week treatment courses could be considered in non-cirrhotic, treatment-naive patients with HCV genotype 1. The Commission recommended 24-week courses in combination with ribavirin to treat HCV genotype 3 patients with cirrhosis or for whom prior treatments have failed. It also recommended the drug to treat HIV patients with HCV. ...