- Gilead Sciences (NASDAQ:GILD +1.2%) announces positive results from four international Phase 3 clinical trials (POLARIS-1, -2, -3, -4) assessing its investigational once-daily, fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) for the treatment of genotypes 1-6 chronic hepatitis C virus (HCV) infection. Complete results will be presented next month at The Liver Meeting in Boston.
- POLARIS-1, which enrolled 263 genotype 1-6 patients who had received prior treatment with an NS5A inhibitor, showed a cure rate (SVR12) of 96% (n=253/263) after 12 weeks of treatment with SOF/VEL/VOX.
- POLARIS-2, in direct-acting antiviral (DAA)-naive genotype 1-6 patients including some with cirrhosis, showed a cure rate of 95% (n=476/501) after eight weeks of treatment.
- POLARIS-3, in DAA-naive cirrhotic genotype 3 patients, showed a cure rate of 96% (n=106/110) after eight weeks of treatment.
- POLARIS-4, in DAA-experienced, NS5A-naive genotypes 1-4 patients, 46% with cirrhosis, showed a cure rate of 97% (n=177/182) after 12 weeks of treatment.
- Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor, velpatasvir is a pan-genotypic NS5A inhibitor and voxilaprevir is a pan-genotypic NS3/4A protease inhibitor.
- The company plans to file a New Drug Application (NDA) for Breakthrough Therapy-tagged SOF/VEL/VOX this quarter followed quickly by a marketing application in Europe.