- The number of people living with HIV in Canada (prevalence) is
increasing1
- An estimated 75,500 Canadians were living with HIV at the end
of 20141
- This represents an increase of 6,700 people (9.7%) since the
end of 20111
- ISENTRESS® (raltegravir) was originally launched in
Canada in 2007
KIRKLAND, QC, Sept. 12, 2017 /CNW Telbec/ - Merck (NYSE:
MRK), known as MSD outside Canada
and the United States, today
announced the availability of ISENTRESS® HD, a new 1200
mg once-daily dose of the company's integrase strand transfer
inhibitor, ISENTRESS®, to be administered orally as two
600 mg film-coated tablets with or without food, in combination
with other antiretroviral agents, for the treatment of HIV-1
infection in adults and adolescents with body weight of at least 40
kg, who are either treatment-naïve or virologically suppressed on
an initial regimen of ISENTRESS® 400 mg twice daily. The
400 mg tablet should not be substituted for the new 600 mg tablet
to create a 1200 mg once-daily dose. Raltegravir once-daily
recently received notice of compliance from Health Canada.
"For the past decade, raltegravir has been used as a component
of treatment regimens for Canadian patients with HIV-1," said Dr.
Shariq Haider, Professor of Medicine
at McMaster University in Ontario. "For these patients, reducing their
pill burden is increasingly important. The addition of this new
convenient once-daily version with a comparable efficacy and safety
to the existing twice-daily version provides physicians with a
welcome therapeutic option. For people living with HIV, reducing
their daily pill management burden is important to their quality of
life and simplifies their ability to be compliant to their chosen
therapy."
This indication for once-daily raltegravir is based on data from
the pivotal Phase 3 ONCEMRK trial, which evaluated the safety and
antiretroviral activity of raltegravir 1200 mg (2 x 600 mg) once
daily versus raltegravir 400 mg twice daily, both in combination
with emtricitabine (+) tenofovir, in treatment-naïve HIV-infected
patients with HIV RNA ≥ 1000 copies/mL. Through 48 weeks of
treatment, the raltegravir 1200 mg (2 x 600 mg) once-daily regimen
was non-inferior to the raltegravir 400 mg twice-daily regimen: 89%
(N=531) of patients receiving raltegravir 1200 mg (2 x 600 mg) once
a day achieved viral suppression of HIV RNA <40 copies/mL
compared to 88% (N=266) of patients receiving raltegravir 400 mg
twice a day, with a 95% confidence interval of 0.5 [-4.2, 5.2].
This was consistent across demographic groups at initiation of
therapy and a variety of patient populations, including those with
high viral load (HIV RNA >100,000 copies/mL).
In ONCEMRK, the rates of discontinuation of therapy due to
clinical and laboratory adverse experiences were 0.8% and 0.4% in
patients receiving raltegravir 1200 mg (2 x 600 mg) once daily and
2.3% and 0% in patients receiving raltegravir 400 mg twice daily.
The most commonly reported clinical adverse reactions (>10% in
either treatment group), of all intensities and regardless of
causality, were headache, nausea, and diarrhea. There were no
drug-related clinical adverse reactions of moderate to severe
intensity occurring in ≥2% of patients in either treatment
group.
This product can be co-administered with a wide range of
antiretroviral agents and non-antiretroviral agents. The potential
for drug-drug interactions must be considered prior to and during
therapy. For complete information, please consult the product
monograph here.
About ISENTRESS®
(raltegravir)
Approved in 2007, raltegravir was the first
integrase strand transfer inhibitor developed for the treatment of
HIV-1 infection. ISENTRESS® is indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and in treatment-experienced children and
adolescents 2 years of age and older with body weight at least 7
kg.
Raltegravir works by inhibiting the activity of HIV integrase,
which prevents the insertion of the HIV genome into the host cell
genome. Inhibiting integrase from performing this essential
function prevents propagation of the viral infection.
Raltegravir is approved as part of combination therapy in 112
countries for treatment of HIV-1 infection in adult patients.
ISENTRESS®, in combination therapy, for use in children
and adolescents with HIV-1 aged two years and older has also been
approved for use in 69 countries. To consult the full Canadian
product monograph for complete prescribing information and
contraindications, warnings, precautions, adverse reactions,
interactions, dosing, and conditions of clinical use regarding
raltegravir, please click here.
About Merck
For over a century, Merck, a leading
global biopharmaceutical company known as MSD outside Canada and the
United States, 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.
For more information about our operations in Canada, visit www.merck.ca and connect with us
on YouTube and Twitter.
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. There can be no guarantees
with respect to pipeline products that the products will receive
the necessary regulatory approvals or that they will prove to be
commercially successful. 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 2016
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).
____________________________
1Public Health Agency of Canada. Summary: Estimates of HIV incidence,
prevalence and proportion undiagnosed in Canada, 2014. Available at
http://www.catie.ca/sites/default/files/2014-HIV-Estimates-in-Canada-EN.pdf
(accessed September 2017).
SOURCE Merck Canada Inc.