Raltegravir: Pivotal Studies Published

Raltegravir, an HIV integrase inhibitor, received FDA approval in 2007 for treatment of drug-resistant HIV infection. This approval was based on results from two manufacturer-sponsored, phase III, randomized studies, BENCHMRK-1 and -2 (JW Infect Dis Oct 17 2007). Now, the results of these studies have been published, with details of subgroup and resistance analyses.

In the combined BENCHMRK studies, 699 patients infected with triple-class–resistant HIV were randomized 2:1 to receive raltegravir or placebo, each together with optimized background therapy (OBT). The median duration of previous therapy was 10 years, and 38% received enfuvirtide as part of the OBT. At week 48, 62% of participants in the raltegravir group had a viral load (VL) <5…