Harvoni ledipasvir regulatory update

The U.K.’s NICE issued a preliminary appraisal recommending Harvoni ledipasvir/sofosbuvir from Gilead as a cost-effective treatment for certain subpopulations of patients with HCV genotypes 1 and 4 at a list price of L38,980 ($60,017) for a 12-week course. Comments are due March 23, with a second appraisal meeting scheduled for April 1.

NICE recommended an 8-week course of Harvoni for treatment-naive, non-cirrhotic patients with HCV genotype 1. The committee recommended a 12-week course for treatment-naive genotype 1 and 4 patients with cirrhosis and for previously treated, non-cirrhotic patients with genotypes 1 or 4. The draft guidance did not recommend Harvoni for previously treated patients with cirrhosis, nor to treat genotype 3. ...