– Gilead's First TAF-based Single Tablet
Regimen Demonstrates High Efficacy with
Improved Renal and Bone Parameters Compared to TDF-based Regimens
–
MISSISSAUGA, ON, May 4, 2017 /CNW/ - Gilead Sciences Canada,
Inc. today recognizes Québec for including GENVOYA® tablets as a
general benefit on the list of the Régie de l'assurance maladie du
Québec (RAMQ), for the treatment of HIV-1 infection.
GENVOYA (150 mg elvitegravir/150 mg cobicistat/200 mg
emtricitabine/10 mg tenofovir alafenamide) is indicated as a
complete regimen for the treatment of human immunodeficiency virus
type 1 (HIV-1) infection in adults and pediatric patients 12 years
of age and older (and weighing ≥ 35 kg) and with no known mutations
associated with resistance to the individual components of
GENVOYA.
"People living with HIV today are increasingly likely to be
receiving treatment for other conditions, such as heart, kidney and
liver disease, because they are living longer than ever before,
exposing them for longer periods of time to the virus and to the
antiviral medications used to treat it," said Dr. Réjean Thomas,
President, Chef Executive Office and Founder/ président-directeur
général et fondateur, Clinique médical L'Actuel, Montréal.
"Therefore, patients need access to new treatments, such as
GENVOYA, that are efficacious, well tolerated and simple to
dose."
GENVOYA received marketing authorization in 2015, and is
Gilead Canada's first tenofovir
alafenamide (TAF)-based single tablet regimen. Since GENVOYA
was granted marketing authorization, Gilead
Canada has received approval two additional TAF-based
regimens, DESCOVY® (emtricitabine/tenofovir alafenamide) tablets
and ODEFSEY™ (emtricitabine/rilpivirine/tenofovir alafenamide)
tablets.
"In clinical studies, TAF has shown improvements in multiple
bone and renal laboratory parameters compared to TDF (tenofovir
disoproxil fumarate)," added Dr. Thomas. "GENVOYA offers a new
treatment option for patients who are new to antiretroviral
treatment, or who may be needing a replacement for an older
antiretroviral regimen in those who are virologically suppressed.
Today, the goal of treatment is beyond achieving an undetectable
status, as we are now able to address longer-term side effects to
help patients live an improved quality of life."
TAF is a novel targeted prodrug of tenofovir that has
demonstrated high antiviral efficacy similar to and at a dose less
than one-tenth that of Gilead's VIREAD® (tenofovir disoproxil
fumarate, TDF). TAF has also demonstrated improvement in surrogate
laboratory markers of renal and bone safety as compared to TDF in
clinical trials in combination with other antiretroviral agents.
Data show that because TAF loads cells, including HIV-infected
cells, more efficiently than TDF, it can be given at a much lower
dose resulting in >90 per cent lower concentrations of tenofovir
in plasma.
"Gilead Canada commends the
continued leadership of Québec to provide access to new treatment
options that help address the evolving needs of a range of HIV
patients," said Kennet Brysting, General Manager, Gilead
Canada. "We will continue to invest in HIV research, and to
work with all public drug plans to ensure equal access to GENVOYA
and other TAF-based regimens that are becoming the cornerstone of
HIV therapy."
GENVOYA does not cure HIV infection or AIDS.
Important Safety Information
GENVOYA has serious
warnings in its Product Monograph regarding the risks of lactic
acidosis/severe hepatomegaly with steatosis, and post treatment
exacerbation of hepatitis. For important safety information
for GENVOYA, including contraindications and additional warnings
and precautions, please see the Canadian Product Monograph.
About Gilead
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
and patients may not see the advantages of GENVOYA over other
therapies and may therefore be reluctant to prescribe 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 Annual Report on Form
10-K for the year ended December 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 Monographs for GENVOYA,
DESCOVY and ODEFSEY are available at www.gilead.ca.
GENVOYA®, DESCOVY®, ODEFSEY™ and VIREAD® 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.