- Gilead Canada recognizes the Ontario Ministry of Health for
providing access to new treatment for people living with HIV
- According to the most recent Public Health Agency of Canada
data, Ontario accounts for the highest number and proportion of
reported HIV cases (38.9 per cent)1
- In clinical trials, BIKTARVY demonstrated high efficacy and a
high barrier to resistance
Gilead Sciences Canada, Inc. (Gilead Canada) today announced
that effective July 31, the Ontario Drug Benefit Program 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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190806005045/en/
(Photo: Business Wire)
“To help 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.
Jason Brunetta, Director at Maple Leaf Research, a treating
physician at Maple Leaf Medical Clinic (Toronto), and a Principal
Investigator on BIKTARVY clinical trials. “In clinical trials
through 96 weeks, BIKTARVY has shown high efficacy and zero
resistance. With convenient once-a-day dosing of a small single
tablet and few pre-screening or ongoing monitoring requirements,
BIKTARVY has simplified treatment initiation, and follow-up, over
time.”
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. 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 Ontario 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 March 31, 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190806005045/en/
FOR MORE INFORMATION IN CANADA: Karen M. Chow, National
Stakeholder Relations and Communications Gilead Sciences Canada,
Inc. (905) 363-8083
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Sep 2023 to Sep 2024