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Now Available in Canada: ISENTRESS® HD (raltegravir), a New Once-Daily Option, in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients

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.

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