(RTTNews) – Gilead Sciences, Inc. (GILD) announced Thursday the approval in Canada for expanded indication of EPCLUSA (Sofosbuvir/Velpatasvir) for the treatment of Chronic Hepatitis C in patients co-infected with HIV.
Gilead Sciences Canada, Inc. received from Health Canada a Notice of Compliance or NOC for updated labeling of EPCLUSA (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen or STR for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV-1.
The supplemental new drug submission was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with EPCLUSA in 106 subjects.
Health Canada granted EPCLUSA an NOC in July 2016, for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.
Brian Conway, President and Medical Director, Vancouver Infectious Diseases Centre, said, “HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded indication, EPCLUSA provides co-infected patients with a much-needed one-pill-a-day regimen that works across all HCV genotypes and at all stages of disease. Being compatible with most widely-used antiretroviral regimens adds to its convenience.”