The DUET trials: etravirine in the management of treatment-experienced HIV-1-infected patients.

The non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine has been approved for use in treatment-experienced, HIV-1-infected patients. The Phase III DUET trials evaluated the long-term efficacy and safety of etravirine versus placebo, each in combination with an antiretroviral background regimen including twice-daily darunavir/ritonavir 600/100 mg, in treatment-experienced patients failing therapy (with baseline plasma viral load of more than 5000 copies/ml and NNRTI and protease inhibitor resistance). At week 24 in DUET-1, 56% of etravirine-treated patients reached the primary end point of viral load below 50 copies/ml compared with 39% of placebo-treated patients (p = 0.0050); in DUET-2, response rates were 62 versus 44%, respectively (p = 0.0003). Pooled data at weeks 48 and 96 confirmed the durability of response with etravirine. With the exception of rash, the safety and tolerability profile of etravirine was similar to that of placebo over the treatment period. Etravirine is expected to ...