– New Data for First Approved Pan-genotypic
Once-Daily Single Tablet Regimen for
Chronic Hepatitis C Virus Infection –
MISSISSAUGA, ON, Sept. 21, 2017 /CNW/ - Gilead Sciences Canada,
Inc. (Gilead Canada) today announced
that Health Canada has granted a Notice of Compliance (NOC) for
updated labeling of EPCLUSA® (sofosbuvir 400mg/velpatasvir 100mg),
the first all-oral, pan-genotypic, once-daily single tablet regimen
(STR) for the treatment of adults with chronic hepatitis C virus
(HCV) infection, to include use in patients co-infected with HIV-1.
Health Canada granted EPCLUSA an NOC in July
2016, for the treatment of adults with genotype 1-6 chronic
HCV infection without cirrhosis or with compensated cirrhosis, or
with decompensated cirrhosis in combination with ribavirin.
"HCV co-infection remains a major cause of morbidity in
HIV-infected individuals. With this expanded indication,
EPCLUSA provides co-infected patients with a much-needed
one-pill-a-day regimen that works across all HCV genotypes and at
all stages of disease. Being compatible with most widely-used
antiretroviral regimens adds to its convenience," said Dr.
Brian Conway, President and Medical
Director, Vancouver Infectious Diseases Centre. "With EPCLUSA,
physicians have an important new treatment option for their HCV/HIV
co-infected patients."
The supplemental new drug submission was supported by data from
the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of
treatment with EPCLUSA in 106 subjects with genotype 1-4 HCV
infection who were co-infected with HIV and on stable
antiretroviral therapy. In the study, 95 per cent (101/106) of
patients achieved the primary endpoint of SVR12, defined as an
undetectable viral load 12 weeks after completing therapy. The
study also included patients with compensated cirrhosis.
The safety profile of EPCLUSA in HCV/HIV co-infected patients
was similar to that observed in HCV mono-infected patients. The
most common adverse events (in at least 10 per cent of subjects)
were fatigue (22 per cent) and headache (10 per cent).
"Canada has committed to eliminating hepatitis C by 2030. To
accomplish this goal, it is imperative that steps be taken to
increase treatment rates in Canada, including treatment for people who are
co-infected with hepatitis C and HIV," said Dr. Morris Sherman, Chairperson, Canadian Liver
Foundation and Hepatologist at Toronto General Hospital. "Hepatitis
C progresses faster in individuals who are co-infected with HIV,
often increasing and speeding up the onset of liver damage. Today,
with pan-genotypic curative hepatitis C therapies approved for
treatment in hepatitis C and HIV co-infected patients, it is an
important time for patients to discuss treatment options with their
health care providers."
"EPCLUSA has already helped further simplify HCV treatment among
mono-infected patients, and we are pleased that HCV/HIV co-infected
patients can benefit from this pan-genotypic single tablet
regimen," said Kennet Brysting, General Manager, Gilead
Canada. "This approval advances the commitment we've made to the
HCV and HIV communities to deliver innovative new treatments that
address their unmet medical needs."
Patient Support Program
To assist eligible HCV
patients in Canada with access to
EPCLUSA, Gilead Canada operates 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 Gilead Momentum
Support Program in Canada, please call 1-855-447-7977.
Important Safety Information
The EPCLUSA Product
Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX REGARDING
THE RISKS OF HEPATITIS B VIRUS (HBV) REACTIVATION IN HCV/HBV
CO-INFECTED PATIENTS. For further details, please see the
Canadian Product Monograph at www.gilead.ca.
Contraindications
When used in combination with
ribavirin (RBV), the contraindications to RBV are applicable to the
combination regimen. Refer to the Product Monograph containing
information on RBV.
Warnings and Precautions
Serious Symptomatic
Bradycardia When Coadministered with Amiodarone: Amiodarone is
not recommended for use with EPCLUSA due to the risk of symptomatic
bradycardia, particularly in patients also taking beta blockers or
with underlying cardiac comorbidities and/or with advanced liver
disease. A fatal cardiac arrest was reported in a patient taking
amiodarone who was coadministered a sofosbuvir-containing regimen.
In patients without alternative, viable treatment options, cardiac
monitoring is recommended. Patients should seek immediate medical
evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect Due to Concomitant Use of
EPCLUSA with P-gp Inducers and/or Moderate to Potent Inducers of
CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John's wort, and carbamazepine should not
be used with EPCLUSA as they may significantly decrease sofosbuvir
and/or velpatasvir plasma concentrations.
Patients with Decompensated Cirrhosis and HCV Genotype 2, 4,
5 or 6: Data to support the treatment of patients with
decompensated cirrhosis who are infected with HCV genotype 2 or
genotype 4 are limited, and there are no data for genotype 5 and
genotype 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.
EPCLUSA should not be administered concurrently with other
medicinal products containing sofosbuvir.
Drug Interactions
Coadministration of EPCLUSA is not
recommended with oxcarbazepine, phenytoin, phenobarbital,
rifabutin, rifapentine and efavirenz due to changes (decreased or
increased) in concentrations of sofosbuvir and/or velpatasvir,
and/or the other agent.
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 at www.gilead.ca.
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 2006.
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 for the
treatment of chronic HCV infection in patients co-infected with
HIV. 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 June 30, 2017, 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,
including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.Gilead.ca.
EPCLUSA and Gilead Momentum Support Program
are registered 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.