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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.
is the text of a recent announcement from the FDA describing the
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.
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%
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.
6 of the label was updated to include the Week 96 safety results.
complete revised label will be posted soon to the FDA website
Be sure to check for 6/29/2010 update.
Klein and K Struble. Food and Drug Administration. HIV/AIDS
Update. June 30, 2010