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On January 18, 2008, the FDA granted accelerated approval for etravirine, the first new NNRTI in nearly 10 years. The medication (previously known as TMC125) will be licensed under the trade name Intelence.
Etravirine is indicated for treatment-experienced adults with HIV strains resistant to existing NNRTIs. Approval of the drug was based on results from the DUET studies (ACC Jul 30 2007), which compared etravirine with placebo in treatment-experienced patients with documented resistance to NNRTIs and PIs; all patients also received optimized background regimens that contained ritonavir-boosted darunavir, plus other agents selected by the investigators as indicated. At 24 weeks, viral-load and CD4-cell–count data signif…