Raltegravir approved for initial therapy
In July, the U.S. Food and Drug Administration approved raltegravir for use as initial therapy in the treatment of HIV infection. The FDA had previously approved raltegravir for treatment of patients with ARV-resistant strains of HIV. The new indication is based on a randomized double-blind noninferiority study of raltegravir vs efavirenz, each given in combination with tenofovir + emtricitabine in treatment-naive adults. At 48 weeks, similar rates of virologic suppression to <50 copies/mL were seen in the two treatment groups: 86% in raltegravir recipients and 82% in efavirenz recipients. CD4 increases also were similar: 189 cells/µL and 163 cells/µL, respectively.
The recommended dosage of raltegravir is 400 mg orally BID.
Treatment guidelines of the U.S. Department of Health and Human Services (most recently updated in November 2008) do not recommend raltegravir for use in initial therapy.
more on raltegravir
1. Lennox J, Dejesus E, Lazzarin A, et al. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Jul 31. [Epub ahead of print]