- Gilead Canada recognizes
Québec's Ministry of Health for providing access
to new HIV treatment, listed under the "Régie de
l'assurance maladie du Québec" List of Medications
- According to the most recent Public Health Agency of Canada
data, Québec accounts for 27.9 per cent of total
reported new cases of HIV, and the second highest diagnosis rate of
HIV1
- In clinical trials, BIKTARVY demonstrated high efficacy and
a high barrier to resistance
MISSISSAUGA, ON, Aug. 15, 2019 /CNW/ - Gilead Sciences Canada,
Inc. (Gilead Canada) today announced
that effective today the Québec public drug insurance plan
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.
"To support the long-term health of people living with HIV, it
is ideal that treatment regimens deliver both durable viral
suppression and a demonstrated tolerability profile," said Dr.
Benoit Trottier, Physician and
Director of Research at Clinique de médecine urbaine du Quartier
latin, and a BIKTARVY clinical trial investigator. "In
clinical trials through 96 weeks, BIKTARVY has shown high efficacy
and no new resistance. Access to BIKTARVY is important for
patients in Québec. With its convenient once-a-day dosing of
a small single tablet this option simplifies treatment, requires
minimal monitoring and is a new option 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 longer-term age-related health
matters, including non-HIV comorbidities (such as cardiac, renal,
liver or bone disease), 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.
According to the Plan d'action commun de Montréal sans sida, in
Québec, 86 per cent of people living with HIV know their status
(2016). In Montreal, 97 per cent of people receiving care
were on antiretroviral treatment and 92 per cent of people living
with HIV on treatment had undetectable viral loads.5
In Canada in 2016, it was estimated that 86 per cent of people
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.6
"Gilead Canada is pleased that
Québec 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 therapy. 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 Canada, where Gilead Alberta ULC (Gilead Alberta) supports the development of new
innovative therapies with its process development and manufacturing
facilities. The 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.
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1 Public Health Agency of Canada,
"HIV in Canada—Surveillance Report, 2017", N Haddad, JS Li, S
Totten, M McGuire, December, 6, 2018.
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2 "Managing HIV infection in patients
older than 50" (Canadian Medical Association Journal)
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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
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4 UNAIDS
https://www.unaids.org/en/resources/909090
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5 Plan d'action commun de Montréal
sans sida:
http://www.montrealsanssida.ca/wp-content/uploads/2018/11/Resume-Plan_d-Action-Commun_MSS_ANG.pdf
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6 Public Health Agency of Canada,
https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/hiv-vih/hiv-vih-eng.pdf
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SOURCE Gilead Sciences, Inc.