- VOSEVI is the First Once-Daily, Single
Tablet HCV Regimen for Re-Treatment, and
Completes Gilead's Portfolio of Sofosbuvir-Based HCV Direct-Acting
Antiviral Treatments -
MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ - Gilead Sciences Canada,
Inc. (Gilead Canada) today announced
that Health Canada has granted a Notice of Compliance for
VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100
mg) tablets, a pan-genotypic single-tablet regimen for the
treatment of chronic hepatitis C virus (HCV) infection in adults
with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A
inhibitor-containing regimen, or with genotype 1, 2, 3 or 4
previously treated with sofosbuvir-containing regimen without an
NS5A inhibitor. The approval is based on data from the Phase
3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI
in direct-acting antiviral-experienced chronic HCV-infected
patients without cirrhosis or with compensated cirrhosis.
"HCV treatment has been transformed by effective direct-acting
antiviral regimens, allowing health care providers the opportunity
to cure many patients. However, for those patients who have
failed with prior therapy, there remains an unmet clinical need for
an effective and well-tolerated option," said Dr. Stephen Shafran, Professor of Medicine, Division
of Infectious Diseases, University of
Alberta. "VOSEVI Phase 3 clinical studies have
resulted in high cure rates among patients who were not previously
cured with several widely-prescribed DAA regimens, providing
physicians with an important new therapeutic option that could
offer hope for their hardest-to-cure patients."
VOSEVI is the latest single-tablet regimen in Gilead's portfolio
of sofosbuvir-based DAA treatments that offer people living with
HCV a short course of therapy to cure their HCV infection, with the
convenience associated with once-daily single-tablet regimens.
Since 2013, Gilead has brought to market four HCV treatments,
including three single-tablet regimens. To date, more than an
estimated 1.5 million patients worldwide have been prescribed
sofosbuvir-based regimens.
"The evolution of Gilead's portfolio of HCV single-tablet
regimens has been driven by our commitment to address previously
unmet needs and put the possibility of cure within reach for as
many HCV patient populations as possible," said Kennet
Brysting, General Manager, Gilead Canada. "The approval of
VOSEVI in Canada completes our HCV
portfolio and this will enable the company to commit to
collaborative partnerships that will help drive progress towards
the goal of eliminating HCV in Canada by 2030."
The approval of VOSEVI is supported by Phase 3 data from the
POLARIS-1 study evaluating 12 weeks of treatment among adults with
HCV genotype 1, 2, 3, 4, 5 or 6 infection with or without
compensated cirrhosis who had failed prior treatment with an NS5A
inhibitor-containing regimen, as well as Phase 3 data from the
POLARIS-4 study evaluating 12 weeks of treatment among adults with
HCV genotype 1, 2, 3 or 4 infection with or without compensated
cirrhosis who had failed prior treatment with a DAA-containing
regimen that did not include an NS5A inhibitor. In these
populations across the two studies, 431 of the 445 patients treated
with VOSEVI (97%) achieved the primary endpoint of SVR12, defined
as maintaining undetectable viral load 12 weeks after completing
therapy.
The most common adverse events (≥10 per cent of patients) among
patients who received VOSEVI were headache, fatigue, diarrhea and
nausea. The proportion of subjects who permanently discontinued
treatment due to adverse events was 0.2 per cent for subjects who
received VOSEVI for 12 weeks.
"As Canada moves forward with its World Health Organization
commitment to eliminate hepatitis C by 2030, it is important for
all patients to have the opportunity to access a cure, regardless
if they are new to treatment, or they have failed a previous
therapy," said Dr. Morris Sherman,
Chairperson, Canadian Liver Foundation and Hepatologist at Toronto
General Hospital. "Treatment should be an option for
everyone, including to those still seeking a cure. The CLF is
pleased to see that additional effective therapies are available,
and are becoming more accessible to all patients, regardless of
where someone lives, or their ability to pay."
Patient Support Program
To assist eligible HCV
patients in Canada with access to
VOSEVI, Gilead Canada has added
VOSEVI to the Gilead Momentum Support Program™, which provides
information to patients and healthcare providers to help facilitate
patient access to medication. For more information regarding
the Momentum Support Program in Canada, please call
1-855-447-7977.
Important Safety Information
The VOSEVI 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
VOSEVI is contraindicated with the
following drugs products: dabigatran etexilate, phenobarbital,
phenytoin, rifampin, rosuvastatin. VOSEVI is also
contraindicated with the herbal product, St. John's wort.
Warnings and Precautions
Serious Symptomatic
Bradycardia When Coadministered with Amiodarone: Amiodarone is
not recommended for use with VOSEVI 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.
Drug Interactions
Coadministration of VOSEVI is not
recommended with carbamazepine, oxcarbazepine, rifabutin,
rifapentine, atazanavir, lopinavir, efavirenz, and cyclosporine due
to changes (decreased or increased) in concentrations of
sofosbuvir, velpatasvir and/or voxilaprevir, and/or the other
agent.
For additional important safety information for VOSEVI,
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 VOSEVI for the treatment of
adults with chronic HCV infection. 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, 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 VOSEVI,
including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.gilead.ca.
VOSEVI 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.