Gilead Sciences announced results from three Phase 2 open-label studies investigating the efficacy and safety of an all-oral pan-genotypic regimen containing Sovaldi (sofosbuvir), a nucleotide analog polymerase inhibitor and GS-5816, a NS5A inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.
The first study, GS-US-342-0109 evaluated 12 weeks of SOF plus GS-5816 with and without RBV in treatment-experienced genotype 1 and 3 patients with and without cirrhosis. The genotype 1 patients had all failed a prior treatment course that included a protease inhibitor.
The second study, ELECTRON 2 evaluated the same combination of SOF plus GS-5816, with and without RBV, for eight weeks in non-cirrhotic, treatment-naïve genotype 3 patients. Patients receiving SOF with GS-5816 100 mg achieved SVR12 rates of 100% (n=26/26) with RBV and 96% (n=26/27) without RBV.
The third study, GS-US-342-0102, evaluated SOF plus GS-5816, with and without RBV, among non-cirrhotic treatment-naïve patients.
All three studies evaluated SOF 400mg plus GS-5816 25mg or 100mg, with and without ribavirin (RBV), for 8 or 12 weeks. Rates of sustained virologic response (SVR12) ranged from 88–100% among those receiving SOF plus GS-5816 100 mg for 12 weeks. The results of Part B, evaluated eight weeks of SOF plus GS-5816, with and without RBV, in patients with genotype 1 or 2 HCV infection. Among genotype 1 patients receiving SOF plus GS-5816 100 mg, SVR12 rates were 81% (n=25/31) and 90% (n=26/29), with and without RBV, respectively. Genotype 2 patients achieved SVR12 rates of 88% (n=23/26) with RBV and 88% (n=23/26) without RBV.
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