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Updates to the Isentress (raltegravir) package insert were approved on April 18, 2012, to include results from the 156-week safety and efficacy data from Protocol 021-11, "A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of raltegravir Versus Efavirenz in Treatment Naïve HIV-Infected Patients, each in Combination With TRUVADA™".
Section 1, Indication and Usage, was updated to reflect data from a trial conducted in treatment-naïve adults through 156 weeks.
Section 6, Adverse Reactions, was updated with the 156 week safety data.
Section 14, Clinical Studies, was updated with the 156-week virologic outcome data. The proportion of subjects with HIV-1 RNA less than 50 copies/mL was 76% for the Isentress treated group compared to 68% for the efavirenz treated group. The difference between treatment groups (95% CI) is 7.4% (-0.1%, 14.7%).
The complete updated labeling will be posted soon at Drugs@FDA.
Isentress is an HIV integrase strand transfer inhibitor manufactured by Merck & Co., Inc.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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