Health Canada approved Gilead’s Vosevi for treating patients with chronic hepatitis C with genotypes 1 through 6 previously treated with an NS5A inhibitor-containing regimen, or with genotypes 1 through 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor, according to a press release.
“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” Kennet Brysting, general manager of Gilead Canada, said in the release. “The approval of Vosevi in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030.”
Phase 3 data from the POLARIS-1 study and the POLARIS-4 study supported the approval. Both studies evaluated the safety of efficacy of Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences) in patients with chronic HCV without cirrhosis or with compensated cirrhosis.