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| |  Etravirine Offers Durable Virologic Efficacy in Patients Resistant to NNRTIs and PIs: Presented at IAS By Charlene Laino CAPE TOWN, South Africa -- July 20, 2009 -- Etravirine has durable, superior virologic efficacy to placebo in the treatment of HIV-infected adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance on a background regimen, according to pooled results from two phase 3 studies. In the pooled analysis of the DUET-1 and DUET-2 studies, 57% of patients in the etravirine arm had an undetectable viral load of <50 copies/mL at 96 weeks, compared with 36% of patients in the placebo arm (P < .0001). The findings were presented here today at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention by Tony Mills, MD, University of California, Los Angeles, Los, Angeles, California. The randomised, controlled DUET-1 and -2 studies, identical in design and conducted across the Americas, Australia, Canada, Europe, Thailand, and Europe, assessed the 24-week efficacy and safety of etravirine in combination with a background in treatment-experienced adult HIV-infected patients with documented evidence of NNRTI and PI resistance. To be eligible, patients had to have a viral load of >5,000 copies/mL, be on a stable antiretroviral therapy regimen, and have evidence of at least 1 NNRTI-resistance-associated mutation, either at screening or from historical resistance tests as well as evidence of 3 or more primary PI mutations at screening. Participants were randomised to receive etravirine 200 mg twice daily (n = 599) or placebo (n = 604), each given in addition to a background regimen. For all patients, the background regimen included darunavir/ritonavir, plus at least 2 investigator-selected antiretroviral drugs. “Virologic response was sustained through week 96,” Dr. Mills reported at IAS. Ninety-one percent of patients in the etravirine arm who achieved an undetectable viral load at week 48 maintained virologic suppression through week 96 versus 88% of patients in the placebo arm, he said. Subgroup analyses showed that etravirine was associated with significantly higher virologic response rates than placebo at week 96 regardless of a patient’s race, age, or region, he added. Funding for the study was provided by Tibotec Pharmaceuticals. [Presentation title: Etravirine (ETR; TMC125) Demonstrates Durable Efficacy in Treatment-Experienced Patients in the DUET Trials: Pooled 96-Week Results. Abstract MOPEB036]
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