ISENTRESS® (raltegravir) In Combination Therapy Demonstrated Long-Term Efficacy, Safety And Tolerability In Previously Untreated Adult Patients With HIV-1 For Up To 240 Weeks

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced final results from the STARTMRK study – the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adults with HIV-1. In this pre-specified exploratory analysis of ISENTRESS ^® (raltegravir) 400 mg Film-coated Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1 patients, virologic efficacy was better than the efavirenz-based regimen at 240 weeks. At all pre-specified time points, the regimen containing ISENTRESS had fewer drug-related adverse events versus the comparator. The 240-week analysis showed that the regimen containing ISENTRESS demonstrated long-term viral suppression and a greater immunologic response, as well as a proven safety and tolerability profile.

These results were presented as a late-breaker [LBPE19] at the 19th International AIDS Conference (AIDS 2012) in Washington, D.C.

ISENTRESS is an integrase inhibitor indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults. This 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 156 weeks.

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 (raltegravir). Additionally, during the initial phase of treatment, immune reconstitution syndrome may occur. (See Important Selected Safety Information below.)

“These new data provide additional perspective on the safety and efficacy of the integrase inhibitor ISENTRESS,” said Dr. Jürgen Rockstroh, University of Bonn, Bonn-Venusberg, Germany. “Long-term data with antiretrovirals is increasingly important for today's HIV patient.”

“Our continued study of ISENTRESS is an example of Merck’s longstanding commitment to HIV,” said Dr. Daria Hazuda, worldwide head of Antiviral Basic Research at Merck, and lead scientist for ISENTRESS. “After more than 25 years of leadership in HIV research, we remain dedicated to conducting comprehensive research to help address the real-world needs of people living with HIV.”

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