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July 10, 2009

Isentress (raltegravir) indication extended for the treatment of HIV-1 infection in treatment-naïve patients

"On July 8, 2009, FDA granted approval to Isentress (raltegravir), for the treatment of HIV-1 infection in treatment-naïve patients. The recommended dose for treatment-naïve adult patients is Isentress 400 mg twice daily, with or without food.

"The use of Isentress in treatment-naïve 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."

Read more in FDA.gov, July 8, 2009.

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