-- British Columbia Also Broadens Access
for Patients with Less Advanced Disease Who Have Other Health
Conditions --
MISSISSAUGA, ON, March 21, 2017 /CNW/ - Gilead Sciences
Canada, Inc. (Gilead Canada) today
announced, effective March 21, 2017,
British Columbia 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 British Columbia
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,
BC PharmaCare 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. In 2018-19, PharmaCare plans to provide
coverage for any resident of the province living with chronic
hepatitis C, regardless of the type or severity of their
disease.
For more information on the expanded access criteria:
http://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/limited-coverage-drug-program/limited-coverage-drugs-sofosbuvir-velpatasvir
"We now have the ability to cure almost all patients with
chronic HCV with a simple, safe and effective 12-week treatment,
regardless of genotype or patient history," said Dr. Alnoor Ramji, Clinical Associate Professor of
Medicine, Gastroenterology and Hepatology, University of British
Columbia. "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 British Columbia, the Public
Health Agency of Canada estimates that more than 53,200 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 British Columbia Ministry of 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.