- Although treatment progress has been made, human
immunodeficiency virus (HIV) is still one of the world's most
serious public health challenges.i In 2018,
approximately 37.9 million people were living with HIV
worldwide.ii During that same year, an estimated 1.7
million people became newly infected globally.iii
- For more than 30 years, Merck has been committed to scientific
research and discovery in HIV that addresses unmet medical needs
and helps people living with HIV have a long and healthy life.
KIRKLAND, QC, Nov. 18, 2019 /CNW/ - Merck Canada Inc., an
affiliate of Merck & Co., Inc., known as MSD outside
the United States and
Canada, announced today that reimbursement will be provided to
PIFELTRO® and DELSTRIGO®, a once-daily NNRTI
regimen for the treatment of HIV-1 infection, effective
October 31st for the
Ontario Drug Benefit Program and November
14th for la Régie de l'assurance maladie du
Québec, RAMQ. Ontarians and Quebecers aged 18 years or older who
are living with an HIV-1 infection will be eligible for
reimbursement under the public program.
"While living well with HIV infection is now a reality for most
people, HIV remains a major public health challenge and identifying
individuals with infection and ensuring access to effective
treatment and care is a priority," says Dr. Fiona Smaill, Infectious Diseases and Medical
Microbiology, McMaster University.
"These two new products, from the class of drugs known as NNRTIs,
provide another simple, effective and well tolerated treatment
choice for patients."
Merck's PIFELTRO® and DELSTRIGO® were
approved for the treatment of HIV-1 by Health Canada in 2018. Both
treatments provide additional options to adults infected with HIV-1
to help manage their disease.
"We're pleased to see both products now reimbursed for patients
living with HIV in Ontario and
Quebec," says Anna Van Acker, President, Merck Canada. "At
Merck, we are committed to scientific research and discovery of new
treatment options that address the unmet medical needs and bring
hope and quality of life to patients living with the consequences
of this devastating disease. This includes ensuring that effective
therapies are accessible to many patients as quickly as
possible."
About HIV-1 Infection
HIV is a virus which causes HIV infection, with acquired
immunodeficiency virus (AIDS) being the most advanced stage of HIV
infection.iv HIV attacks the body by targeting and
dismantling the immune system's infection-fighting CD4
cells.v As the body loses CD4 cells, the immune system
struggles to fight off infections and certain cancers.vi
If left untreated, the immune system can be broken down further by
HIV and result in AIDS.vii
HIV-1 is the most predominant type of HIV infection, accounting
for approximately 95 per cent of all infections
worldwide.viii
About PIFELTRO®
PIFELTRO® is a new non-nucleoside reverse
transcriptase inhibitor (NNRTI) of HIV-1 to be administered in
combination with other antiretroviral medicines. The approval of
this therapy is based on data from two randomized, international,
multicenter, double-blind, and active-controlled pivotal Phase 3
trials entitled DRIVE-FORWARD and DRIVE-AHEAD. PIFELTRO®
is indicated, in combination with other antiretroviral medicinal
products for the treatment of adults infected with HIV-1 without
past or present evidence of viral resistance to doravirine.
In DRIVE-FORWARD, once-daily PIFELTRO, demonstrated non-inferior
efficacy to darunavir + ritonavir (DRV+r), each in combination with
two nucleoside reverse transcriptase inhibitors (NRTI) at 48 weeks
(84% in the PIFELTRO group achieved viral suppression of HIV-1 RNA
<50 copies/mL vs. 80% in the DRV+r group). The most frequently
reported adverse reactions considered possibly or probably related
to PIFELTRO were nausea (6%) and headache (5%).ix
About DELSTRIGO®
DELSTRIGO® is a once-daily fixed-dose combination
tablet of doravirine, lamivudine and tenofovir disoproxil fumarate,
designed as a complete regimen for the treatment of HIV-1 infection
in appropriate patients. The approval of this therapy is based on
data from two randomized, multicenter, double-blind and active
controlled pivotal Phase 3 trials entitled DRIVE-AHEAD and
DRIVE-SHIFT. DELSTRIGO® is indicated as a complete
regimen for the treatment of human immunodeficiency virus-1 (HIV-1)
infection in adults without past or present evidence of viral
resistance to doravirine, lamivudine or tenofovir. In DRIVE-AHEAD,
once-daily DELSTRIGO demonstrated non-inferior efficacy to the
combination of efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF)
at 48 weeks (84% in the DELSTRIGO group achieved viral suppression
of HIV-1 RNA <50 copies/mL vs. 81% in the EFV/FTC/TDF group).
The most frequently reported adverse reactions considered possibly
or probably related to DELSTRIGO were dizziness (7%) and nausea
(5%).x
About Merck
For over a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the
United States and Canada,
has been inventing for life, bringing forward medicines and
vaccines for many of the world's most challenging diseases. Through
our prescription medicines, vaccines, biologic therapies and animal
health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships.
Today, Merck continues to be at the forefront of research to
advance the prevention and treatment of diseases that threaten
people and communities around the world - including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer's
disease and infectious diseases including HIV and Ebola.
In Canada, Merck markets a
broad range of vaccines, pharmaceutical and animal health products
and is one of the top R&D investors in Canada, with investments totaling $69 million in 2018 and more than $1 billion since 2000. Based in Kirkland, Québec, Merck employs approximately
765 people across the country. For more information about our
operations in Canada, visit
www.merck.ca and connect with us on YouTube and Twitter
@MerckCanada.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes
"forward-looking statements" within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995. These statements are based upon the current beliefs and
expectations of the company's management and are subject to
significant risks and uncertainties. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States
and internationally; global trends toward health care cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; the company's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the company's patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company's 2017
Annual Report on Form 10-K and the company's other filings with the
Securities and Exchange Commission (SEC) available at the SEC's
Internet site (www.sec.gov).
Please see the product monograph for PIFELTRO®
(doravirine) at:
https://www.merck.ca/static/pdf/PIFELTRO-PM_E.pdf
Please see the product monograph for DELSTRIGO®
(doravirine/lamivudine/tenofovir disoproxil fumarate) at:
https://www.merck.ca/static/pdf/DELSTRIGO-PM_E.pdf
References
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|
i
U.S. Department of Health & Human
Services. Global statistics. Available at
https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics
|
ii
UNAIDS. Global HIV & AIDS statistics
– 2019 fact sheet. Available at
https://www.unaids.org/en/resources/fact-sheet
|
iii
UNAIDS. Global HIV & AIDS statistics
– 2019 fact sheet. Available at
https://www.unaids.org/en/resources/fact-sheet
|
iv
Aids Info – U.S. National Library of
Medicine. HIV/Aids: The Basics Available at
https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/19/45/hiv-aids--the-basics
|
v
Aids Info – U.S. National Library of
Medicine. HIV/Aids: The Basics Available at
https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/19/45/hiv-aids--the-basics
|
vi
Aids Info – U.S. National Library of
Medicine. HIV/Aids: The Basics Available at
https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/19/45/hiv-aids--the-basics
|
vii
Aids Info – U.S. National Library of
Medicine. HIV/Aids: The Basics Available at
https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/19/45/hiv-aids--the-basics
|
viii Avert. Global information and education on HIV and
AIDS. HIV Strains and Types. Available at
https://www.avert.org/professionals/hiv-science/types-strains
|
ix
Product Monograph. PIFELTRO®.
2018.
|
x
Product Monograph. DELSTRIGO®.
2018.
|
SOURCE Merck