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U.S. Department of Health and Human Services

For Consumers

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Isentress (raltegravir potassium) label update reflects 96 week safety/efficacy results in treatment-naive and treatment-experienced patients

On June 29, 2010, the Isentress (raltegravir potassium) tablet label was updated with the Week 96 safety and efficacy results in treatment-naïve and treatment-experienced patients.

In the treatment-naïve trial 021, the proportion of subjects with HIV RNA < 50 copies/mL was 82% for the Isentress 400 mg twice daily regimen compared to 78% for the Efavirenz arm. The treatment difference and 95% CI was 3.8% (-2.8%, 10.4%).

In the treatment-experienced pooled analysis of trials 018 and 019, the proportion of subjects with HIV RNA < 50 copies/mL was 55% for the Isentress 400 mg twice daily + optimized background regimen compared to 27% for the optimized background regimen arm.

Section 6 of the label was updated to include the Week 96 safety results.

The complete revised label will be available soon on the FDA website at Drugs@FDA.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration