Gilead Sciences has received notice of compliance from Health Canada for its once-daily oral nucleotide analog polymerase inhibitor Sovaldi or sofosbuvir 400mg tablets for the treatment of chronic hepatitis C or CHC infection.
Sovaldi is indicated for compensated liver disease, including cirrhosis, to treat genotype 1 or 4 CHC in combination with pegylated interferon and ribavirin, and to treat genotype 2 or 3 CHC in combination with ribavirin.
The company said that the recommended dose of Sovaldi + peginterferon alfa+ ribavirin, should be given to treatment-na?ve patients with genotype 1 or 4 CHC for 12 weeks; Sovaldi + ribavirin for patients with genotype 2 CHC for 12 weeks; and Sovaldi + ribavirin to patients with genotype 3 CHC for 16 weeks.
The company had filed the marketing application for Sovaldi in Canada in May 2013 and secured the Priority Review.
Gilead expects the federal and provincial reimbursement review for Sovaldi under the Canadian Common Drug Review process.
Sovaldi was approved in the US in December 2013, while applications are pending in the EU, Australia and New Zealand, Switzerland and Turkey, and it is expected to be available in Canada in early 2014.
The marketing authorisation for Sovaldi was based on data from four Phase III trials including Neutrino, Fission, Positron and Fusion, which assessed Sovaldi combined with either RBV or RBV plus peg-IFN.
Three of the trials evaluated Sovaldi plus RBV in genotype 2 or 3 patients who were either treatment-na?ˉve (Fission), treatment-experienced (Fusion) or peg-IFN intolerant, ineligible or unwilling (Positron).
Neutrino evaluated Sovaldi in combination with peg-IFN/RBV in treatment na?ˉve patients with genotypes 1, 4, 5 or 6.
