HIV/AIDS Update: Isentress (Raltegravir) Indication Extended for the Treatment of HIV-1 Infection in Treatment-Naive Patients
July 9, 2009
On July 8, 2009, FDA granted approval to Isentress (raltegravir), for the treatment of HIV-1 infection in treatment-naive patients. The recommended dose for treatment-naive adult patients is Isentress 400 mg twice daily, with or without food.
The use of Isentress in treatment-naive patients is based on a 48-week randomized, double-blind, active control trial to evaluate the safety and efficacy of Isentress 400 mg twice daily + emtricitabine + tenofovir versus Sustiva (efavirenz) 600 mg + emtricitabine + tenofovir. The proportion of patients with HIV RNA < 50 copies/mL was 87% for the Isentress group compared to 82% for the Sustiva group. The difference between Isentress and Sustiva with respect to HIV RNA < 50 copies/mL and the 95% confidence intervals is 4.7% (-1.3%, 10.6%).
Several other changes were made to the package insert and include the following major revisions --
Full Prescribing Information Section:
Treatment-Naive Subjects: By Week 48 in the STARTMRK trial, the primary raltegravir resistance-associated substitutions were observed in 3 (1 with Y143R and 2 with Q148H/R) of the 6 virologic failure subjects with evaluable paired genotypic data.
Section 14 CLINICAL STUDIES includes 48 week efficacy data from Protocol 02.
Minor editorial changes were made to the patient package insert for consistency with other antiretrovirals.
Issentress (raltegravir) is an integrase inhibitor made by Merck & Co.
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