-- 12-Week Treatment with EPCLUSA Provides
High Cure Rates (SVR12)
For All Six Hepatitis C Genotypes --
MISSISSAUGA, ON, July 14, 2016 /CNW/ - Gilead Sciences
Canada, Inc. (Gilead Canada) has
received a Notice of Compliance (NOC) from Health Canada for
EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg), the first
once-daily, pan-genotypic single tablet regimen for the treatment
of adults with genotype 1-6 chronic hepatitis C virus (HCV)
infection. EPCLUSA - for 12 weeks - is for use in patients
without cirrhosis or with compensated cirrhosis, and in combination
with ribavirin (RBV) for patients with decompensated
cirrhosis. EPCLUSA is the first single tablet regimen approved
for the treatment of patients with HCV genotype 2 and 3, without
the need for RBV. Health Canada had previously granted EPCLUSA
a Priority Review, which is given to a medication that offers a
significant advance in treatment over existing options for a
serious, life-threatening or severely debilitating condition.
"This newly-approved treatment represents an important step
forward in how we treat HCV," said Dr. Jordan Feld, Hepatologist and Research Director,
Francis Family Liver Clinic, Toronto Centre for Liver Disease,
Toronto General Hospital. "We can now cure the majority of
HCV-infected patients with a simple, safe and effective 12-week
treatment, regardless of genotype or treatment history."
The approval of EPCLUSA is supported by data from four
international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and
ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035
patients with genotype 1-6 chronic HCV infection, without cirrhosis
or with compensated cirrhosis (Child-Pugh A) received 12 weeks of
EPCLUSA. The ASTRAL-4 study randomized 267 patients with
genotype 1-6 chronic HCV infection, with decompensated cirrhosis
(Child-Pugh B) to receive 12 weeks of EPCLUSA with or without RBV
or 24 weeks of EPCLUSA. The primary endpoint for each study
was sustained virologic response 12 weeks after completing therapy
(SVR12).
Of the 1,035 patients treated with EPCLUSA for 12 weeks in the
ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent)
achieved SVR12. 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.
"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.
"Having a therapy that works for all genotypes will make treatment
easier for both patients and physicians to manage, but it must be
accessible regardless of where someone lives or their ability to
pay."
"At Gilead, we continue to be motivated by the urgent need to
develop medicines and transform and simplify care for people living
with HCV," said Ed Gudaitis, General
Manager, Gilead Canada. "We
are committed to working with drug plans across the country to help
ensure EPCLUSA is accessible to patients who need treatment for
this life-threatening disease."
Patient Support Program
To assist eligible HCV patients in Canada with access to EPCLUSA, Gilead Canada has added EPCLUSA to the Gilead
Momentum Support Program®, which provides information to
patients and healthcare providers to help ensure patient access to
medication.
For more information regarding the Momentum Support
Program® in Canada,
please call 1-855-447-7977.
Important Safety Information
- When used in combination with RBV, the contraindications to RBV
are applicable to the combination regimen.
- Data to support the treatment of patients with decompensated
cirrhosis who are infected with HCV genotype 2 or 4 are limited,
and there are no data for genotype 5 and 6 HCV-infected patients
with decompensated cirrhosis. The indication for treatment of these
patients is based on extrapolation of relevant clinical and in
vitro data.
- Safety and efficacy has not been established in patients with
severe hepatic impairment (Child-Pugh Class C).
- Should not be administered concurrently with other medicinal
products containing sofosbuvir.
- Should not be used with potent P-glycoprotein (P-gp) inducers
and/or moderate to potent inducers of CYP2B6, CYP2C8, or
CYP3A4.
- Co-administration with amiodarone is not recommended due to
risk of symptomatic bradycardia.
- If administered with amiodarone, cardiac monitoring is
recommended.
- Co-administration with an efavirenz-containing regimen is not
recommended.
For additional important safety information for EPCLUSA,
including the complete warnings and precautions, adverse reactions
and drug-drug interactions, please see the Canadian Product
Monograph for EPCLUSA.
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 risks that physicians and patients may not see advantages
of EPCLUSA over other therapies and may therefore be reluctant to
prescribe the product, and the risk that payers may be reluctant to
approve or provide reimbursement for 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 Quarterly Report on Form 10-Q for
the quarter ended March 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 will be
available at www.Gilead.ca.
EPCLUSA™ and Gilead Momentum Support
Program® are trademarks 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.