- Gilead Canada recognizes the
Government of Alberta for providing access to new treatment for
people living with HIV
- In 2017, Alberta accounted for 11.7 per cent of reported HIV
cases in Canada1
- In clinical trials, BIKTARVY demonstrated high efficacy and
a high barrier to resistance
MISSISSAUGA, ON, Aug. 26, 2019 /CNW/ - Gilead Sciences Canada,
Inc. (Gilead Canada) today announced
that, effective August 22, the
Province of Alberta will provide eligible patients with access to
Biktarvy® (bictegravir 50 mg/emtricitabine 200
mg/tenofovir alafenamide 25 mg) tablets, a once-daily single tablet
and complete regimen for the treatment of HIV-1 infection in
adults. Health Canada granted a Notice of Compliance for
BIKTARVY in July 2018.
"BIKTARVY offers many benefits to patients living with HIV,"
said Dr. Stephen Shafran, Professor
of Medicine, Division of Infectious Diseases, University of Alberta. "As one small pill daily,
with or without food, it offers a very high barrier to resistance
(no treatment-emergent resistance seen in clinical trials
or after more than 17 months on the U.S. market), is
extremely well tolerated, has almost no drug-drug interactions and
requires minimal monitoring."
Dr. Shafran added, "BIKTARVY is also well suited for rapid start
and for many patients on older antiretroviral regimens, including
those with non-HIV comorbidities such as cardiac, renal, liver or
bone disease."
Treatment for people living with HIV is evolving, with an
increasing focus on dealing with age-related, non-HIV comorbidities
and drug related issues that develop at younger ages and more often
among people living with HIV than among those without HIV
infection.2
Canada Strives to Achieve 90-90-903
UNAIDS
has set a goal of 90-90-90 by 2020 meaning: 90 per cent of all
people living with HIV will know their HIV status; 90 per cent of
all people with diagnosed HIV infection will receive sustained
antiretroviral therapy, and 90 per cent of all people receiving
antiretroviral therapy will have viral
suppression.4 According to the most recent data
from the Public Health Agency of Canada (2016), 63,110 people were
living with HIV in Canada. In 2016, it was estimated that 86
per cent of Canadians living with HIV are diagnosed, 81 per cent of
patients diagnosed are on treatment, and 91 per cent of positive
Canadians on treatment have achieved viral
suppression.5
"Gilead Canada is pleased that
Alberta will provide access to new treatment options that help
address the evolving needs of a range of people living with HIV,"
said Kennet Brysting, Vice President and General
Manager, Gilead Canada. "Gilead is committed to
improving care and simplifying therapy for people living with HIV,
providing new treatments to support Canada to achieve its 90-90-90
goals, and continuing to invest in research in next-generation
treatments, including the ultimate goal of therapies that could
potentially cure HIV infection in patients."
BIKTARVY AND TAF
BIKTARVY is Gilead Canada's fourth tenofovir alafenamide
(TAF)-based single tablet regimen. The TAF-based therapies
include: Genvoya® (elvitegravir 150 mg/cobicistat 150
mg/ emtricitabine 200 mg/tenofovir alafenamide 10 mg),
Descovy® (emtricitabine
200 mg/tenofovir alafenamide 10 mg and 25 mg) tablets and
Odefsey® (emtricitabine
200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) tablets.
Process and analytical development of bictegravir, one of the
components of BIKTARVY, took place in Edmonton, Alberta where Gilead Alberta ULC
(Gilead Alberta) supports the
development of new innovative therapies with its process
development and manufacturing facilities. With close to 400
highly-skilled employees, the Alberta facility produces active
pharmaceutical ingredients (APIs) for the company's investigational
compounds as well as for some commercial products including those
APIs used in BIKTARVY for HIV.
The approval of BIKTARVY was supported by data from four Phase 3
studies: Studies 1489 and 1490 in treatment-naïve HIV-1
infected adults and Studies 1844 and 1878 in
virologically-suppressed adults. The trials were comprised of a
diverse population of 2,414 participants, including a wide range of
adult age groups and races/ethnicities. BIKTARVY met its
primary objective of non-inferiority at 48 weeks across all four
studies. Through 48 weeks, no participants in any of the four
studies failed BIKTARVY with treatment-emergent virologic
resistance, no patients discontinued BIKTARVY due to renal adverse
events and there were no cases of proximal renal tubulopathy or
Fanconi syndrome. The most common adverse reactions in
patients taking BIKTARVY were diarrhea, nausea and headache.
BIKTARVY does not cure HIV infection or AIDS.
Important Safety Information
BIKTARVY has serious
warnings and precautions box in its product label including the
risk of post-treatment acute exacerbation of hepatitis B (HBV) in
patients who are co-infected with HIV-1 and HBV and have
discontinued products containing emtricitabine (FTC) and/or
tenofovir disoproxil fumarate (TDF) and may occur with
discontinuation of BIKTARVY. Prior to, or when initiating
BIKTARVY, healthcare professionals should test for hepatitis B
virus infection, and closely monitor hepatic function with both
clinical and laboratory follow-up for at least several months in
patients who are co-infected with HIV-1 and HBV and discontinue
BIKTARVY. Patients with chronic hepatitis B or C and treated
with antiretroviral therapy are at increased risk for severe
hepatic adverse events.
BIKTARVY should not be co-administered with any other
antiretroviral products including those containing bictegravir,
emtricitabine and tenofovir alafenamide, or those containing
lamivudine or tenofovir disproxil fumarate. BIKTARVY should not be
administered with adefovir dipivoxil.
BIKTARVY is contraindicated with the following drug products:
dofetilide, rifampin. BIKTARVY is also contraindicated with the
herbal product, St. John's
wort.
For all important safety information, including
contraindications, additional warnings and precautions, adverse
reactions and drug interactions, please see the Canadian Product
Monograph at www.gilead.ca.
About Gilead Sciences
Gilead Sciences, Inc. 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 35 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.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention,
testing and linkage to care, and cure research. Today, it's
estimated that 11.5 million people living with HIV globally receive
antiretroviral therapy provided by Gilead or one of the company's
manufacturing partners.
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 BIKTARVY and the
possibility of unfavourable results from additional clinical trials
involving BIKTARVY. 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,
2019, 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.
The Canadian Product Monograph for BIKTARVY,
including Boxed Warning, is available at
www.gilead.ca.
BIKTARVY, GENVOYA, DESCOVY, and ODEFSEY 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.
1
|
Public Health Agency
of Canada, "HIV in Canada—Surveillance Report, 2017", N
Haddad, JS Li, S Totten, M McGuire, December, 6, 2018.
|
2
|
"Managing HIV
infection in patients older than 50" (Canadian Medical Association
Journal)
|
3
|
Government of Canada:
https://www.canada.ca/en/public-health/services/publications/diseases-conditions/summary-measuring-canada-progress-90-90-90-hiv-targets.html
|
4
|
UNAIDS
https://www.unaids.org/en/resources/909090
|
5
|
Public Health Agency
of Canada,
https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/hiv-vih/hiv-vih-eng.pdf
|
SOURCE Gilead Sciences, Inc.