Health Canada Issues Notice Of Compliance For Sovaldi™ (Sofosbuvir) For The Treatment Of Chronic Hepatitis C

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has issued a Notice of Compliance for Sovaldi™ (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection. Sovaldi is indicated for use in adult patients with compensated liver disease, including cirrhosis, for the treatment of genotype 1 or 4 CHC in combination with pegylated interferon and ribavirin, and for the treatment of genotype 2 or 3 CHC in combination with ribavirin. The recommended dose and treatment duration for Sovaldi combination therapy is as follows:
         
    Treatment   Duration
Treatment-naïve patients with genotype 1 or 4 CHC   Sovaldi + peginterferon alfa

+ ribavirin
  12 weeks
Patients with genotype 2 CHC   Sovaldi + ribavirin   12 weeks
Patients with genotype 3 CHC   Sovaldi + ribavirin   16 weeks*

* Consideration should be given to extending the duration of therapy beyond 16 weeks and up to 24 weeks guided by an assessment of the potential benefits and risks for the individual patient (these factors may include cirrhosis status and treatment history).

Treatment regimen, duration and response to Sovaldi are dependent on viral genotype and patient population, and associated baseline factors. Sovaldi must not be administered as monotherapy. The Canadian Product Monograph is available at www.Gilead.ca.

Gilead submitted the marketing application for Sovaldi in Canada on May 17, 2013 and was granted Priority Review by Health Canada. Gilead is awaiting federal and provincial reimbursement review for Sovaldi under the Canadian Common Drug Review process. Gilead anticipates that Sovaldi will be available to patients in Canada early next year . Sovaldi was approved in the United States on December 6, 2013 and applications are pending in the European Union, Australia and New Zealand, Switzerland and Turkey.

“I believe sofosbuvir has the potential to transform HCV treatment in Canada as it addresses many unmet patient needs,” said Jordan Feld, MD, MPH, Staff Hepatologist, Toronto Western Hospital, Department of Medicine, Division of Gastroenterology. “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.”

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