Merck announced that the FDA has approved a labeling update for Isentress (raltegravir) tablets to include 156-week data from the STARTMRK study.

This Phase III multi-center, double-blind, randomized, active-controlled, non-inferiority study (n=563) evaluated previously untreated HIV-1 infected adult patients with HIV-1 RNA >5,000 copies/mL who received either 400mg Isentress orally twice daily (n=281) or 600mg Sustiva (efavirenz tablets; Bristol-Myers Squibb Virology) orally once daily (n=282), each in combination with Truvada (tenofovir/emtricitabine tablets; Gilead Sciences). The primary endpoint of the study was a reduction in HIV-1 viral load to <50 copies/mL and the evaluation of safety and tolerability at Week 48. Results showed that the regimen containing Isentress demonstrated long-term viral suppression, a greater immunologic response, and a proven safety and tolerability profile at 156 weeks.

Isentress is an integrase inhibitor indicated for the treatment of HIV-1 infection in adult patients and pediatric patients ages >2 years as part of combination HIV therapy.

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