Revised Raltegravir (Isentress) Label Adds 96 Week Data

The U.S. Food and Drug Administration (FDA) this week announced that the product label information for the integrase inhibitor raltegravir (Isentress) has been updated to include longer-term safety and efficacy data from the STARTMRK (021) trial of people starting antiretroviral therapy for the first time, and the BENCHMRK 1 and 2 (018 and 019) trails of treatment-experienced patients. Raltegravir remained potent over 2 years with no notable long-term safety concerns.

Below is the text of a recent announcement from the FDA describing the changes.

HIV/AIDS Update -- June 30, 2010

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

In the treatment-naive 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 [Sustiva] 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 posted soon to the FDA website at Drugs@FDA. Be sure to check for 6/29/2010 update.



R Klein and K Struble. Food and Drug Administration. HIV/AIDS Update. June 30, 2010