-- Alberta Also Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions --
MISSISSAUGA, ON, April 3, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced, effective immediately, Alberta will provide public access to EPCLUSA™ (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030.
EPCLUSA, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV.
The approval of EPCLUSA was supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. Of the 1,035 patients without cirrhosis or with compensated cirrhosis treated with EPCLUSA for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent) achieved SVR12 (sustained virologic response 12 weeks after the end of treatment). In ASTRAL-4, patients with decompensated cirrhosis who received EPCLUSA with RBV for 12 weeks achieved a high SVR12 rate (94 per cent) compared to those who received EPCLUSA for 12 weeks or 24 weeks without RBV (83 per cent and 86 per cent, respectively). The most common adverse events in the four ASTRAL studies were headache and fatigue, and were comparable in incidence to the placebo group included in ASTRAL-1.
The listing in Alberta follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, Alberta will expand access to include patients with less advanced disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement.
For more information on the expanded access criteria:
"We now have the ability to cure almost all patients with chronic HCV with a simple and safe 12-week treatment, regardless of viral genotype or patient history," said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Disease, University of Alberta. "Broader access to EPCLUSA, particularly at the earlier stage of the disease, means that we can move more quickly to help patients achieve a cure, improve their quality of life, and prevent cases of advanced liver disease that is a significant financial burden for the healthcare system."
In Alberta, the Public Health Agency of Canada estimates that more than 24,000 people are living with chronic HCV. In Canada, it is estimated that 250,000 Canadians are living with chronic HCV, with thousands of new cases diagnosed each year. There are six genotypes of hepatitis C. Genotype 1 infection is the most prevalent genotype in Canada representing 64.1 per cent of infected individuals. Genotypes 2 and 3 account for approximately 14.1 per cent and 20.2 per cent of infections in Canada, whereas genotypes 4, 5, and 6 are less prevalent in Canada (0.3 per cent).
"Canada, and other countries, have committed to eliminating hepatitis C by 2030, and to accomplish this goal we need to significantly increase treatment rates," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and hepatologist at Toronto General Hospital. "Treatment regimens are getting shorter, simpler and more widely effective across genotypes meaning that treatment is now easier for both patients and physicians to manage.
"Currently, an estimated 44 per cent still remain undiagnosed, so increasing treatment rates also means improving screening and diagnosis, which is why the Canadian Liver Foundation recommends that all Canadians born between 1945-1975 receive a one-time test for hepatitis C," added Dr. Sherman. "Treatment should be an option for everyone, but the cost of treatment has been an obstacle. We're glad to see that the pCPA and the provinces are taking steps to make these treatments accessible regardless of where someone lives or their ability to pay."
"Gilead Canada is pleased that the pCPA and Alberta Health are recognizing the innovation and clinical value of EPCLUSA for the treatment of all genotypes of hepatitis C in a single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada. "Broader treatment access for patients will potentially have a profound impact on disease elimination efforts in Canada, and supporting such efforts is a key priority for our company. We will continue to work closely with all jurisdictions to bring this simple and cost-effective curative treatment to all eligible patients, regardless of their genotype or stage of fibrosis."
About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc., is the Canadian affiliate of Gilead Sciences, Inc., and was established in Mississauga, Ontario, in 2005.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing EPCLUSA™. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Canadian Product Monograph for EPCLUSA™ can be found at www.Gilead.ca
EPCLUSA™ is a trademark of Gilead Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please visit the company's website at www.Gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE Gilead Sciences, Inc.
For further information: FOR MORE INFORMATION IN CANADA, CONTACT: Karen M. Chow, National Stakeholder Relations and Communications, Gilead Sciences Canada, Inc., (905) 363-8083