Isentress Labeling Now Includes Long-Term Data
The FDA has approved new labeling for Isentress (raltegravir; Merck) film-coated tablets. Isentress is an integrase inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients ages >2 years weighing >10kg as part of combination HIV therapy.
The new update includes 240-week results from the STARTMRK study, a Phase 3 double-blind, non-inferiority study evaluating an integrase inhibitor in treatment-naïve adult patients with HIV-1 infection (N=563). The study results show that the regimen containing Isentress was non-inferior to the regimen containing efavirenz (Sustiva; Bristol-Myers Squibb Virology) at reducing HIV-1 viral load to undetectable levels (<50 copies/mL) at 240 weeks. Also, the regimen containing Isentress demonstrated a greater immunologic response than the efavirenz-containing regimen with a mean baseline increase in CD4 cell count of 295 cells/mm3 vs. 236 cells/mm3, respectively.
Furthermore, a long-term safety and tolerability profile through the 240 weeks in treatment-naïve adult patients with HIV-1 infection was established.
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