-- 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."
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.