Revised Raltegravir (Isentress) Label Adds 96 Week Data

		SUMMARY: 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

Isentress (raltegravir) • News Articles

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.

7/2/10

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