Treating children with HIV is challenging - Adherence to treatment is vital

KIRKLAND, QC, Jan. 15, 2013 /CNW Telbec/ - Despite significant therapeutic advances in the treatment of HIV/AIDS in Canada and around the world, treating children with HIV can be especially challenging.

"One of the biggest challenges we physicians face in treating people infected with HIV, particularly children, is getting them to take their medications as prescribed. Adherence to HIV therapy is vital to prevent the virus from developing resistance to life-saving drugs," said Christos Karatzios MD, Assistant Professor of Pediatrics in the Division of Infectious Diseases, Montreal Children's Hospital. "When the virus becomes resistant the drug is no longer effective and new ones have to be available, or else treatment fails."

Merck Canada announced today that ISENTRESS^® (raltegravir) is now approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced children and adolescents two years of age and older. Chewable tablets will be available to children two to 11 years of age.¹

"The approval of raltegravir for kids with HIV is important because it provides pediatricians with a new drug that is known from its use in adults and recent studies in children, to be well-tolerated with a good safety profile," continued Dr. Karatzios. "A number of children find that some current HIV drug therapies taste bad and subsequently refuse to take their medications altogether, or vomit after swallowing them."

Raltegravir is a palatable chewable HIV drug available for children
According to Dr. Karatzios, "Taste can be a real barrier to kids taking their meds, especially when they're between the ages of two and ten. If it tastes bad they don't want to take it. Doctors now have a new HIV drug therapy that we expect children will take more readily. This is good news, because no physician wants to see a child and the family suffer with the consequences of untreated HIV."

How children contract HIV
Mother-to-child transmission of HIV can occur during gestation (in utero transmission) or during delivery when the newborn comes into contact with maternal blood and cervical-vaginal secretions. In the absence of any intervention, it is estimated that 25% of pregnant women who are HIV positive will transmit the virus to their infant either during pregnancy or at birth. If a seropositive mother breastfeeds her baby, the risk of transmission increases to an estimated 35%.

Although there has been a decline in the rate of mother-to-child transmission of HIV, the absolute number of infants exposed to HIV in utero or during birth is on the rise.

Clinical data for raltegravir
The pediatric indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of raltegravir through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected treatment-experienced children and adolescents two through 18 years of age.

The study enrolled 126 treatment-experienced children and adolescents who received either the 400 mg tablet formulation (six through 18 years of age) or the chewable tablet formulation (two through 11 years of age) with an optimized background regimen. Of the 126 patients, 96 received the recommended dose of raltegravir.

Ninety-three patients (97 per cent) completed 24-weeks of treatment. At Week 24, 54 per cent of patients achieved a viral load of less than 50 copies/mL and the mean CD4 cell count increase from baseline was 119 cells/mm (3.8 per cent).

The safety profile in children two through 18 years of age was comparable to that observed in adults.

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 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. It is now also available for treatment-experienced children and adolescents two years of age and older.

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. These statements are based upon the current beliefs and expectations of Merck'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; Merck'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 Merck's patents and other protections for innovative products; and the exposure to litigation, including patent 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 2011 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).

The news release is available at www.cnw.ca

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¹ ISENTRESS^® Product Monograph. November 28, 2012.  Available online at:
http://www.merck.ca/assets/en/pdf/products/ISENTRESS-PM_E.pdf. Accessed January 2013
² Public Health Agency of Canada, 2010.  Available online at: http://www.phac-aspc.gc.ca/aids-sida/publication/epi/2010/7-eng.php. Accessed January 2013
³ Public Health Agency of Canada, 2010.  Available online at: http://www.phac-aspc.gc.ca/aids-sida/publication/epi/2010/7-eng.php. Accessed January 2013

SOURCE: MERCK

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