Health Canada has issued a notice of compliance for Gilead Sciences’ once-daily oral nucleotide analogue polymerase inhibitor Sovaldi (sofosbuvir) 400mg tablets to treat adult patients with chronic hepatitis C (CHC) infection.
The tablets are 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.
According to the company, the recommended dose of Sovaldi + peginterferon alfa+ ribavirin, should be given to treatment-naïve patients with genotype 1 or 4 CHC for 12 weeks; Sovaldi + ribavirin should be administered for patients with genotype 2 CHC for 12 weeks; and Sovaldi + ribavirin to patients with genotype 3 CHC for 16 weeks.
Gilead submitted the marketing application for Sovaldi in Canada on May 17 and was granted Priority Review by Health Canada. The company is now awaiting federal and provincial reimbursement review for Sovaldi under the Canadian Common Drug Review process.
Expected to be available in Canada in early 2014, Sovaldi is already approved in the US with other applications pending in the EU, Australia and New Zealand, Switzerland and Turkey.
Toronto Western Hospital Department of Medicine staff hepatologist Jordan Feld said sofosbuvir has the potential to transform HCV treatment in Canada.
"The high cure rates, shortened treatment duration, and potential to eliminate or reduce interferon injections give us our best opportunity to successfully treat Canadians with hepatitis C," Feld said.
The marketing authorisation was supported by data secured 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 four trials evaluated Sovaldi plus RBV in genotype 2 or 3 patients who were either treatment-naÃ¯ve (Fission), treatment-experienced (Fusion) or peg-IFN intolerant, ineligible or unwilling (Positron).
Neutrino assessed Sovaldi in combination with peg-IFN/RBV in treatment naÃ¯ve patients with genotypes 1, 4, 5 or 6.
While patients who achieve SVR12 are considered cured of HCV, trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90%.
An oral nucleotide analogue inhibitor of the HCV NS5B polymerase enzyme, Sovaldi is a direct-acting agent that interferes directly with the HCV lifecycle by suppressing viral replication.