— Reimbursement of Harvoni Within Five Months of Health Canada Notice of Compliance Brings Patients Earlier Opportunity for a Cure —

MISSISSAUGA, Ontario, Mar 24, 2015 (BUSINESS WIRE) — Gilead Sciences Canada, Inc. (Gilead Canada) today announced that multiple provinces will provide public access to Harvoni™ (ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults. In Canada, it is estimated that more than 250,000 Canadians are living with chronic HCV infection, with thousands of new cases diagnosed each year.1 Genotype 1 infection represents an estimated 65 per cent of patient cases.2

Public reimbursement comes after a positive recommendation from the Common Drug Review, and as a result of a productive collaboration between Gilead Canada and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure participating provinces are able to provide timely access to patients in need of curative treatment. This review, co-led by the BC Ministry of Health and the Ontario Ministry of Health and Long-Term Care, resulted in an agreement with member provinces to fund the innovative therapy for patients.

“We have been waiting for an innovative therapy like Harvoni since interferon was first used to treat the disease,” said Dr. Alnoor Ramji, Clinical Associate Professor of Medicine (Gastroenterology and Hepatology), University of British Columbia. “This is a transformative, interferon-free therapy, with a combination of high cure rates, good tolerability and simplicity of treatment. Harvoni provides patients with the confidence to commit to therapy and a very high probability to achieve a cure.”

Current treatments include interferon and ribavirin that often exclude patients from treatment or lead to early discontinuation of treatment due to associated side effects. Harvoni represents a significant advance in the treatment of genotype 1 HCV infection, the most prevalent genotype in Canada. Harvoni is the only once-daily, single tablet regimen that offers cure rates between 94 and 99 per cent, eliminates the need for interferon and ribavirin, and shortens the duration of treatment to as little as eight weeks for many patients. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL. Recently, the Canadian Association for the Study of the Liver updated the Canadian consensus guidelines on the management of hepatitis C and recommended Harvoni as first-line therapy for all genotype 1 patients.

“Today’s announcement recognizes the significant health-system and societal benefits associated with curing this disease and preventing its complications,” said Dr. Paul Marotta, Associate Professor, University of Western Ontario and with London Health Sciences Centre. “Access to Harvoni will help us confront this serious public health issue and start formulating longer-term solutions that may prove relevant to the hepatitis C disease elimination efforts across Canada.”

In a recent article, “Burden of disease and cost of chronic hepatitis C virus infection in Canada,” (Canadian Journal of Gastroenterology and Hepatology), leading Canadian hepatitis C specialists highlighted an expected 205 per cent increase in cases of liver cancer, a 160 per cent increase in liver-related deaths, and a 60 per cent increase in total healthcare costs over the next 20 years.2 Recently, the article was recognized with a scientific award for its groundbreaking research in Canada.
In addition to Harvoni, Gilead Canada’s Sovaldi® (sofosbuvir) has also been listed for public reimbursement for chronic HCV genotypes 1, 2 and 3 infection in multiple provinces.

“We live in an era of rapid evolution in the treatment of chronic hepatitis C infection, and Gilead Canada is pleased that our collaboration with the pCPA has allowed multiple provinces to recognize the clinical value of Harvoni as a simple, well tolerated and curative therapy for patients living with genotype 1 HCV,” said Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc. “Gilead Canada will continue to work closely with all provinces and territories to bring this cost-effective, once-daily treatment to patients across Canada.”

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