Isentress Shown to Be More Effective in Ongoing Head-to-Head HIV Study

Favourable long-term tolerability and metabolic profile

MONTREAL, Oct. 20, 2011 /CNW Telbec/ - For the first time, after 192 weeks of the ongoing STARTMRK head-to-head study comparing Merck's integrase inhibitor ISENTRESS® (raltegravir) used in combination therapy to an efavirenz-based combination therapy, a product has demonstrated superior antiretroviral efficacy in previously untreated HIV-infected patients. These data are being presented at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Boston, Massachusetts from October 20-23, 2011.

"The new STARTMRK results show that raltegravir was more effective, better tolerated and had less impact on lipids, including cholesterol, in treatment-naïve patients," said Dr. Colin Kovacs, a Canadian STARTMRK investigator and a primary care physician with 17 years of HIV/AIDS clinical care experience. "These results demonstrate just how much HIV treatments continue to evolve."

STARTMRK is an ongoing multicenter, double-blind, active-controlled, Phase III non-inferiority study, with 563 patients randomized to receive either raltegravir or efavirenz, both in combination with the backbone therapy tenofovir/emtricitabine. Primary analysis was at week 48 and secondary analysis at week 96. In this new pre-specified exploratory analysis after 192 weeks, 76.2% (n=214/281) of raltegravir patients versus 67% (n=189/282) of efavirenz patients (95% confidence interval (CI) 1.6, 16.4) had HIV RNA concentration ("viral load") of less than 50 copies per mL - the goal of therapy. The regimen containing raltegravir also showed a greater immunological effect with a greater increase in CD4 cell count from baseline (360.7 cells/mm3 for raltegravir vs. 300.9 cells/mm3 for efavirenz; 95 percent CI 24.1, 95.4). CD4 cells are a subset of white blood cells that help fight HIV infection.

Fewer adverse events and drug discontinuations
Drug-related clinical adverse events occurred less often with raltegravir than efavirenz (50% vs. 80%; p<0.001). Raltegravir was generally well tolerated with fewer discontinuations due to clinical adverse events (5% for raltegravir vs. 8% for efavirenz). At week 192, raltegravir also had less impact on fasting lipids.

30th anniversary of HIV/AIDS epidemic
"When the HIV/AIDS epidemic struck 30 years ago, HIV was a death sentence. Then triple therapy emerged, but the early drugs were associated with very challenging side effects," stated Dr. Réjean Thomas, who founded in 1987 the Montreal-based Clinique médicale l'Actuel, a pioneer in the treatment of HIV/AIDS. "Today the treatment paradigm has evolved to lifelong therapy and we are more concerned with managing the potential development of other chronic diseases. In this context, it is important to note that raltegravir has little effect on the kidney, liver, blood sugar and cholesterol."

An estimated 65,000 Canadians were living with HIV infection at the end of 2008 and non-AIDS related events are becoming a prominent cause of sickness and death in this population.2

In 2009, Ontario accounted for 41.9% of all positive HIV tests reported to the Public Health Agency of Canada (PHAC), followed by Quebec (21.4%), British Columbia (14.0%), Alberta (9.1%) and Saskatchewan (8.2%).3

Men who have sex with men (MSM) accounted for over 80% of all HIV cases in 1985, but just 41.8% in 2009.4 Women accounted for approximately 25% of HIV diagnoses in Ontario between 2002 and 2008, compared to 3% prior to 2001.5 Also, Aboriginals continue to be overrepresented in the HIV epidemic in Canada and are making up a growing percentage of prevalent HIV infections, increasing by 24% from 2005 to 2008.

About ISENTRESS®
ISENTRESS® (raltegravir) is the only integrase inhibitor approved in Canada. By blocking the action of the integrase enzyme, raltegravir limits the ability of the HIV virus to replicate and infect new cells.

Raltegravir is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV−1) infection in adult patients. This indication is based on the evidence of efficacy of ISENTRESS® from the analysis of 96-week data from three ongoing, randomized, double-blind, controlled trials. Two of these studies, BENCHMRK 1 and BENCHMRK 2, were conducted in antiretroviral treatment-experienced HIV-1 infected adult patients and one, STARTMRK, was conducted in treatment-naïve adults.7

Raltegravir has been available in Canada for use in treatment-experienced patients since November 2007 and for adults starting HIV treatment for the first time since October 2009.

About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our medicines, vaccines, biologic therapies, and consumer and animal 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 healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca.

Forward Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions. Merck 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 Merck's 2009 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).

ISENTRESS® is a Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.

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1 Public Health Agency of Canada. HIV/AIDS EPI Updates June 2010. Chapter 1: National HIV Prevalence and Incidence Estimates in Canada for 2008. Accessed at: http://www.phac-aspc.gc.ca/aids-sida/publication/epi/2010/1-eng.php
2 Therapeutic Guidelines. Antiretroviral treatment (ARV) of adult HIV infection. British Columbia Centre for Excellence in HIV/AIDS. January 2011. Page 33.
3 Public Health Agency of Canada. Surveillance Report to December 2009. Accessed at: http://www.phac-aspc.gc.ca/aids-sida/publication/survreport/2009/dec/0-eng.php
4 Public Health Agency of Canada. Surveillance Report to December 2009. Accessed at: http://www.phac-aspc.gc.ca/aids-sida/publication/survreport/2009/dec/0-eng.php
5 Ontario Women's Health Equity Report. Accessed at: http://www2.catie.ca/sites/default/files/pdf/POWER_Study_Chapter_11_lores.pdf
6 Public Health Agency of Canada. HIV/AIDS EPI Updates June 2010. Chapter 8: HIV/AIDS Among Aboriginal People in Canada. Accessed at: http://www.phac-aspc.gc.ca/aids-sida/publication/epi/2010/1-eng.php
7 ISENTRESS® Product Monograph. September 8, 2010. Accessed at: http://www.merck.ca/assets/en/pdf/products/ISENTRESS-PM_E.pdf

 

For further information:

Sheila Murphy
Merck
514-428-2748

Roch Landriault/Stephanie Lyttle
NATIONAL Public Relations
514-843-2345/514-843-2365

 

Posted: October 2011

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