-- Quebec Broadens Access for Patients with
Less Advanced Disease Who Have Other Health Conditions
--
MISSISSAUGA, ON, March 20, 2017 /CNW/ - Gilead Sciences
Canada, Inc. (Gilead Canada)
commends the continued leadership of Quebec in the treatment of hepatitis C with
the listing of EPCLUSA™ (sofosbuvir/velpatasvir) tablets effective
on March 22, 2017. EPCLUSA is
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 in Quebec, and is
a significant contribution to advancing 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.
New médicament d'exception criteria for SOVALDI® (sofosbuvir),
HARVONI® (ledipasvir/sofosbuvir) and EPCLUSA will increase access
to patients with a lower stage of disease and poor prognosis.
These new criteria are available on the RAMQ website.
For more information on the expanded access criteria:
http://www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/liste_med_2017_03_22_fr.pdf
"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. Peter Ghali, Hepatologist, and Program Director,
Hepatology training, McGill University
Health Centre. "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."
The Institut national de la santé publique du Québec (INSPQ)
estimates that between 40,000 to 75,000 people in the province
could have chronic hepatitis C infection. Between 1990 and
2014, 39,700 individuals were identified with hepatitis C. In
2015, an additional 1,073 cases were identified, thus supporting
the importance of access to treatment to prevent the future
complications of the disease.1 There are six
genotypes of hepatitis C. Genotype 1 infection is the most
prevalent genotype representing 62 per cent of infected
individuals. Genotypes 2 and 3 account for approximately 6.9
per cent and 25 per cent of infections, whereas genotypes 4, 5, and
6 are less prevalent in Québec at 6.1 per cent.2
"We are very pleased that access to treatments is now expanded
to a broader population of hepatitis C patients in our province,"
said Laurence Mersilian, Executive Director, The Centre and
Association for People Living with Hepatitis C (CAPAHC). "We
wish to thank and congratulate the Government of Quebec for its continued leadership and
commitment to care for those living with hepatitis C."
"Gilead Canada is pleased that
INESSS (Institut national d'excellence en santé et services
sociaux) and the Ministry of Health and Social Services 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.
References:
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https://www.inspq.qc.ca/formation/institut/itss/hepatite-c-se-mobiliser-pour-accroitre-depistage-et-traitement
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https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Fevrier_2017/Epclusa_2017_02.pdf
SOURCE Gilead Sciences, Inc.