Gilead reports more HCV data, 1Q13 earnings

Gilead Sciences Inc. (NASDAQ:GILD) reported interim data from the Phase II LONESTAR trial evaluating a once-daily, oral fixed-dose combination of sofosbuvir plus ledipasvir ( GS-5885) to treat chronic HCV genotype 1 infection. In non-cirrhotic, treatment-naïve patients, sofosbuvir plus ledipasvir for eight weeks led to a sustained virologic response (SVR) eight weeks after the end of treatment in 95% of patients, and sofosbuvir plus ledipasvir for eight weeks with ribavirin led to an SVR8 rate of 100%. In treatment-experienced patients who had previously failed therapy with an HCV-specific protease inhibitor-based regimen, 95% of patients in both the sofosbuvir plus ledipasvir for 12 weeks and sofosbuvir plus ledipasvir for 12 weeks with ribavirin arms achieved an SVR4.

Gilead is evaluating the fixed-dose combination of sofosbuvir -- a single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor -- plus ledipasvir -- an HCV NS5A protein inhibitor -- in the Phase III ION-1 and ION-2 trials. Gilead plans to start a third Phase III trial -- ION-3 -- of the combination this quarter. ...