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ARTICLE | Clinical News

Sofosbuvir: Interim Phase II data

May 6, 2013 7:00 AM UTC

Gilead reported interim data from the 5-arm, open-label, U.S. Phase II LONESTAR trial in 100 patients with chronic HCV genotype 1 infection evaluating a once-daily, oral fixed-dose combination of 400 mg sofosbuvir plus 90 mg ledipasvir. In non-cirrhotic, treatment-naïve patients, sofosbuvir plus ledipasvir for 8 weeks led to an SVR 8 weeks after the end of treatment in 95% of patients (n=20); sofosbuvir plus ledipasvir for 8 weeks with ribavirin led to an SVR8 rate of 100% (n=21); and sofosbuvir plus ledipasvir for 12 weeks led to an SVR4 rate of 100% (n=19). 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 (n=19) and sofosbuvir plus ledipasvir for 12 weeks with ribavirin (n=21) arms achieved an SVR4. All treatment arms were well tolerated. ...