Gilead receives approval in Canada for Epclusa (sofosbuvir/velpatasvir), the first once-daily pan-genotypic (genotypes 1-6) single tablet regimen for the treatment of chronic hepatitis C

Business Wire

14 July 2016 - Two week treatment with Epclusa provides high cure rates for all six hepatitis C genotypes.

Gilead Canada has received a notice of compliance from Health Canada for Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa - for 12 weeks - is for use in patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin for patients with decompensated cirrhosis.

Epclusa is the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Health Canada had previously granted Epclusa a priority review, which is given to a medication that offers a significant advance in treatment over existing options for a serious, life-threatening or severely debilitating condition.

"This newly-approved treatment represents an important step forward in how we treat HCV," said Dr. Jordan Feld, Hepatologist and Research Director, Francis Family Liver Clinic, Toronto Centre for Liver Disease, Toronto General Hospital. "We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history."

View Gilead Sciences press release

Michael Wonder

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Michael Wonder