Health Canada Issues Notice Of Compliance For Sovaldi(tm) (sofosbuvir) For The Treatment Of Chronic

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." An estimated 250,000 Canadians are living with chronic hepatitis C virus (HCV), but because the disease can progress for many years without causing noticeable symptoms, about 35 percent of these individuals do not know they are infected. HCV disproportionately impacts "baby boomers, " individuals born between 1945 and 1965, and the Canadian Liver Foundation now recommends that all Canadian baby boomers be tested for the virus. The current standard of care for HCV in Canada involves up to 48 weeks of therapy with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing regimen, which may not be suitable for certain types of patients. The marketing authorization is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, which evaluated 12 or 16 weeks of treatment with Sovaldi combined with either RBV or RBV plus peg-IFN. Three of these studies evaluated Sovaldi plus RBV in genotype 2 or 3 patients who were either treatment-naive (FISSION), treatment-experienced (FUSION) or peg-IFN intolerant, ineligible or unwilling (POSITRON). NEUTRINO evaluated Sovaldi in combination with peg-IFN/RBV in treatment naive patients with genotypes 1, 4, 5 or 6. Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent. For full study details, see the Clinical Studies section of the Product Monograph. more things http://online.wsj.com/article/PR-CO-20131216-904155.html












Wait Times for Patients Who Need Gastroenterology Care Are Getting Longer CAG provides 'total wait time'





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