Canada: NOC granted to Canada’s first “interferon-free” combo, sofosbuvir/ledipasvir!

Canada’s first “interferon-free combo” for hepatitis C, sofosbuvir+ledipasvir, now known by tradename HARVONI, was granted a “Notice of Compliance” (NOC) by Health Canada on Oct. 16, 2014. The NOC is basically an authorization to the combo’s maker, Gilead Sciences, to market this treatment in the Canadian market. The pill, taken once a day for 8, 12, or 24 weeks (depending on condition of liver and previous treatment history), is only approved for use with genotype 1 patients with chronic hepatitis C. It can now be purchased in Canadian pharmacies with a physician’s prescription.
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Access product monograph at http://www.gilead.ca/pdf/ca/harvoni_pm_english.pdf .

Canadian patients can either pay out-of-pocket or through some private insurance agencies. However HARVONI still is not yet covered (reimbursed) by any of Canada’s Pharmacare public insurance agencies. This step will entail several more months of investigations and reports at the provincial level.

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