Ontario Becomes First Province To List EPCLUSA™ On Public Drug Plan To Treat All Six Genotypes Of Chronic Hepatitis C Infection

Feb. 22, 2017
Ontario Becomes First Province To List EPCLUSA™ On Public Drug Plan To Treat All Six Genotypes Of Chronic Hepatitis C Infection

-- Ontario Also Broadens Access for Patients
with Less Advanced Disease with Co-Factors --

MISSISSAUGA, ON, Feb. 22, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced, effective February 28th, 2017, Ontario 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 with compensated disease 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 receiving 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, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

The Ontario listing 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, Ontario 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: http://www.health.gov.on.ca/en/pro/programs/drugs/formulary42/summary_edition42_20170228.pdf

"We now have the ability to cure the majority of patients with chronic HCV with a simple, safe and effective 12-week treatment, regardless of genotype or patient history," said Dr. Curtis Cooper, Associate Professor of Medicine, University of Ottawa, and Director, The Ottawa Hospital and Regional Hepatitis Program. "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 and improve their quality of life, while saving valuable funds associated with the significant long-term burden of illness and costs to the healthcare system."

In Ontario, the Public Health Agency of Canada estimates that more than 102,000 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 the Ontario Ministry of Health and Long-Term Care 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."

Related
ZEPATIER^®
Feb. 22, 2017
Ontario and British Columbia expand treatment access to chronic hepatitis C (CHC) patients
Effective February 28, Ontario will become the first province to reimburse ZEPATIER^®  (elbasvir/grazoprevir), a simple one pill, once daily, 12 week no ribavirin regimen for most patients, and will be followed by British Columbia on March 21

In addition to patients with liver fibrosis stage F2+, patients with liver fibrosis stage F0 and F1 with poor prognostic factors, who had no public access to a potential cure under existing public plans, are now eligible for treatment

Patients with CHC genotypes 1 and 4, with chronic kidney disease (CKD) and intraveinous drug users - representing the highest number of new cases¹ - will have access to treatment

KIRKLAND, QC, Feb. 22, 2017 /CNW Telbec/ - An estimated 185,000 people in Ontario and

British Columbia have hepatitis C, a chronic liver disease that, if left untreated, can lead to cirrhosis, liver cancer and liver transplants.² Merck Canada Inc. today announced that the Government of Ontario and of British Columbia are strengthening their commitment in the global fight against hepatitis C by becoming the first provinces to reimburse ZEPATIER^® (elbasvir/grazoprevir). Zepatier is indicated in the treatment of chronic hepatitis C genotypes 1, 3 or 4 infections in adults patients.³ The product monograph with detailed product indication is available online by clicking here.
"We're pleased to have worked with the pan-Canadian Pharmaceutical Alliance (pCPA) and participating jurisdictions to provide access to Zepatier to patients who need it, including those at higher risk," says Chirfi Guindo, President and Managing Director, Merck Canada Inc. "Hepatitis C is a curable disease, and today's announcement brings us one step closer to eradicating the virus in Canada."

For the first time special populations, including hepatitis C patients with fibrosis stage F0 and F1 who are co-infected with human immunodeficiency virus (HIV) or hepatitis B virus or who have chronic kidney disease (CKD), will be eligible for treatment as of February 28^th under the Ontario Drug Benefit Program (ODB), and as of March 21^st under B.C.'s PharmaCare program.

"The publicly funded availability of Zepatier in Canada for hepatitis C treatment represents a major milestone in the access to care for patients; not only those patients with advanced liver damage or cirrhosis have access to treatment but now those who may progress to more serious liver damage in the future can be cured. The dedication of Merck to addressing clinical studies in targeted and specific populations in need such as those with cirrhosis, advanced kidney disease and those who inject drugs, allow all treaters to use this treatment regimen to cure their patients safely," said Dr. Sergio Borgia, Medical Director and Corporate Division Head of the Infectious Disease Program at William Osler Health System.

These provincial public funding announcements follow the World Health Organization's (WHO) adoption of  the first global health strategy on viral hepatitis, which includes a goal of 30% reduction in new cases of hepatitis B and C by 2020 and a 10% reduction in mortality, as well as increased access to treatment for hepatitis B and C.⁴ In June 2016, the Government of Canada announced its commitment in the global fight against viral hepatitis with the adoption of the Global Strategy on Viral Hepatitis. It has for objective to eliminate hepatitis B and C by 2030.⁵

Feb. 22, 2017
More patients to benefit from hepatitis C treatments
Thousands of British Columbians living with hepatitis C will have better access to treatment as a result of successful negotiations brokered by the pan-Canadian Pharmaceutical Alliance (pCPA).
“This agreement changes the landscape for hepatitis C patients living in B.C.,” said Health Minister Terry Lake. “Not only are there four new treatment options for what is now a curable virus, but the savings that were negotiated will allow us to cover treatment options for all hepatitis C patients – rather than just those in more advanced stages of the disease.”
British Columbia and Ontario co-led the negotiations with the drug manufacturers on behalf of the pCPA. The alliance helps provinces and territories leverage their collective buying power and negotiate better prices for new drugs.....

Daklinza (daclatasvir) – new
Epclusa (sofosbuvir/velpatasvir) – new
Harvoni (ledipasvir/sofosbuvir)
Sovaldi (sofosbuvir)
Sunvepra (asunaprevir) – new
Zepatier (elbasvir/grazoprevir) – new

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