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The Merck Manuals
Oncology Information Center
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and the ADAP Crisis Task Force (ACTF) today announced that the company will extend its commitment to support state AIDS Drug Assistance Programs (ADAPs), which have struggled to meet growing needs in recent years due to funding shortfalls. Through the new agreement, which extends through Dec. 31, 2014, Merck will:
ADAPs reach approximately one-third of people with HIV estimated to be receiving care nationally. The renewal of the existing special pricing program through 2014 is the fourth major ADAP response by Merck in five years. Merck was the first company to freeze the price of an antiretroviral (ARV) therapy for ADAPs.
ISENTRESS (raltegravir) is an integrase inhibitor indicated in combination with other ARV agents for the treatment of HIV-1 infection in adults and children two years of age and older and weighing at least 10 kg. The adult indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class ARV [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adult patients through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.
The indication for children and adolescents two years of age and older is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24 weeks in a multi-center, open-label, noncomparative study in HIV-1 infected children and adolescents two to 18 years of age. The safety and efficacy of ISENTRESS have not been established in children less than two years of age.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. Severe, potentially life-threatening and fatal skin reactions have been reported with ISENTRESS. Additionally, during the initial phase of combination ARV treatment, immune reconstitution syndrome may occur. (See Important Selected Safety Information below.)
“We applaud Merck’s continued perseverance and dedication to providing medications to people living with HIV in response to the growing need for access to antiretroviral medicines through ADAPs,” said Chris Hanson, a member of the ACTF and manager of the Michigan ADAP. “Merck has a long history of working collaboratively to help ensure that HIV treatments are available to people most in need through ADAPs.”
“Merck has steadfastly supported the ACTF since 2002. We are proud to reaffirm our long-standing commitment to ADAPs and their mission to help people living with HIV,” said Chirfi Guindo, vice president and general manager, HIV, Merck. “ADAPs continue to experience fiscal instability as a result of a changing healthcare system. By working together as partners – government, community and industry – we can help to support these critical state programs, and help provide access to medicines for uninsured and underserved HIV patients.”
Important Selected Safety Information
ISENTRESS does not cure HIV-1 infection or AIDS.
Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS (raltegravir) and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develop and monitor clinical status, including liver aminotransferases closely.
Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.
ISENTRESS chewable tablets contain phenylalanine, a component of aspartame, which may be harmful to patients with phenylketonuria.
Coadministration of ISENTRESS with drugs that are strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may result in reduced plasma concentrations of raltegravir.
Rifampin, a strong inducer of UGT1A1, reduces plasma concentrations of ISENTRESS. Therefore, the dose of ISENTRESS for adults should be increased to 800 mg twice daily during coadministration with rifampin. There are no data to guide coadministration of ISENTRESS with rifampin in patients below 18 years of age.
The most commonly reported (≥ 2% in the ISENTRESS treatment group) drug-related clinical adverse reactions of moderate to severe intensity in treatment-naïve adult patients receiving ISENTRESS compared with efavirenz were insomnia (4% vs 4%), headache (4% vs 5%), nausea (3% vs 4%), fatigue (2% vs 3%), and dizziness (2% vs 6%), respectively. In treatment-experienced adult patients receiving ISENTRESS, the most commonly reported (≥ 2% in either treatment group) drug-related clinical adverse reactions of moderate to severe intensity and at a higher incidence compared with placebo was headache (2% vs <1%). In both studies, intensities were defined as: Moderate (discomfort enough to cause interference with usual activity); or Severe (incapacitating with inability to work or do usual activity).
In treatment-experienced children and adolescents two through 18 years of age receiving ISENTRESS, the frequency, type and severity of drug related adverse reactions through Week 24 were comparable to those observed in adults.
Grade 2 to 4 creatine kinase laboratory abnormalities were observed in patients treated with ISENTRESS. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions.
Rash occurred more commonly in treatment-experienced subjects receiving regimens containing ISENTRESS plus darunavir/ritonavir, compared to subjects receiving ISENTRESS without darunavir/ritonavir or darunavir/ritonavir without ISENTRESS. However, rash that was considered drug-related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.
ISENTRESS (raltegravir) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.
ISENTRESS is Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients and pediatric patients ages two years and older and weighing at least 10 kg as part of combination HIV therapy. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.ISENTRESS is now approved in combination therapy in more than 76 countries for use in treatment-naïve adult patients with HIV-1 and in more than 110 countries for use in treatment-experienced adult patients with HIV-1. ISENTRESS, in combination therapy, for use in pediatric patients with HIV-1 has also been approved for use in 33 countries. Merck is continuing to move forward with filings in additional countries around the world.
To assist patients taking ISENTRESS, Merck offers the SUPPORT™ program, which provides personal support and patient advocacy regarding individual reimbursement issues. For more information about the SUPPORT™ program, please visit www.merckhelps.com or call 1-800-850-3430.
Merck’s Commitment to HIV
For close to 30 years, Merck has been at the forefront of the response to the HIV epidemic, and has helped to make a difference through our proud legacy of commitment to innovation, collaborating with the community and expanding global access to medicines. In the United States, we are helping to address healthcare disparities through educational programs and resources that align with the National HIV Strategy. Merck is dedicated to applying our scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HIV worldwide.
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 prescription medicines, vaccines, biologic therapies, and consumer care 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
About the ADAP Crisis Task Force (ACTF)
The ACTF was formed in December 2002 by NASTAD and a group of state AIDS/ADAP directors concerned about the fiscal crisis facing ADAPs nationwide. The ACTF works in partnership with manufacturers of ARV and other HIV-related medications to reduce drug costs and improve access to medications for clients in the nation’s ADAPs. It is estimated that ACTF agreements with companies have saved ADAPs approximately $1.75 billion since 2003. NASTAD provides logistical support to the ACTF.
Founded in 1992, NASTAD is a nonprofit national association of state and territorial health department HIV/AIDS program directors who have programmatic responsibility for administering HIV/AIDS and viral hepatitis health care, prevention, education, and supportive services programs funded by state and federal governments. For more information, visit www.NASTAD.org.
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 2012 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 Prescribing Information for ISENTRESS at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf and Patient Information for ISENTRESS at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ppi.pdf.
Pamela Eisele, (908) 423-5042
Claire Mulhearn, (908) 423-7425
Carol Ferguson, (908) 423-4465
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