-- Nova Scotia Also Broadens Access for
Patients
with Less Advanced Disease Who Have Other Health Conditions
--
MISSISSAUGA, ON, May 1, 2017 /CNW/ - Gilead Sciences Canada, Inc.
(Gilead Canada) today announced,
effective immediately, Nova Scotia
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 Nova Scotia
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,
Nova Scotia will expand access to
include patients with less advanced liver 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:
https://novascotia.ca/dhw/pharmacare/pharmacists_bulletins/Pharmacists_Bulletin_April_17-02.pdf
"We now have the ability to cure the vast majority of persons
living with chronic HCV infection using a simple, safe and
effective 12-week treatment, regardless of genotype or treatment
history," said Dr. Lisa Barrett,
Clinician Scientist, Infectious Diseases at NSHA and Dalhousie
University. "Broader access to EPCLUSA, including some people
with early stages of liver disease, means we can cure HCV and
improve quality of life, while saving valuable funds associated
with the significant long-term burden of illness and costs to the
healthcare system."
In Nova Scotia, the Public
Health Agency of Canada estimates that more than 4,252 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 Nova Scotia 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 and patients may not see the
advantages of EPCLUSA over other therapies and may therefore be
reluctant to prescribe the product. 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 Annual Report on Form 10-K for the
year ended December 31, 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.