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Merck Announces Final Results From The STARTMRK Study

Merck (MRK: Quote), known as MSD outside the United States and Canada, announced final results from the STARTMRK study which is the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adults with HIV-1.

The company said that in this pre-specified exploratory analysis of ISENTRESS 400 mg Film-coated Tablets in combination therapy in previously untreated 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, the company added.

ISENTRESS is an integrase inhibitor indicated in combination with other antiretroviral or 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.

Severe, potentially life-threatening and fatal skin reactions have been reported with ISENTRESS. Additionally, during the initial phase of treatment, immune reconstitution syndrome may occur, Merck noted.

Commenting about ISENTRESS, the company stated that it is currently the first and only approved integrase inhibitor for the treatment of HIV-1. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity.

Other HIV-1 drugs in use inhibit two other enzymes critical to the HIV-1 replication process - protease and reverse transcriptase, but ISENTRESS is the only approved drug that inhibits the integrase enzyme.

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by RTT Staff Writer

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