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| |  HIV Patients Resistant to Non-Nucleoside Reverse Transcriptase Inhibitors Experience Superior Results With Etravirine: Presented at AIDS 2008 By Kate Jongbloed MEXICO CITY -- August 10, 2008 -- Patients with human immunodeficiency virus (HIV) who have had resistance to certain non-nucleoside reverse transcriptase inhibitors (NNRTIs) experienced greater viral suppression with etravirine compared with similar patients using other NNRTI regimens, according to research presented here at the 17th International AIDS Conference (AIDS 2008). The effect was consistent across racial groups. "Patients in the etravirine group consistently achieved higher response rates than those in the placebo group, irrespective of enfuvirtide use, race, disease characteristics, or previous [NNRTI] use," said Pedro Cahn, MD, Huesped Foundation, Buenos Aires, Argentina, and the immediate past-president of the International AIDS Society, Geneva, Switzerland. Dr. Cahn and colleagues conducted a pooled 48-week analysis of the phase 3, randomised, double-blind, placebo-controlled DUET-1 and -2 trials, to assess the impact of baseline characteristics on the virologic response to etravirine. "Etravirine provided added benefit in each subgroup," said Dr. Cahn at his poster presentation here on August 5. A total of 1,203 patients from around the world who had experienced resistance to NNRTI regimens in the past participated in the DUET trials. DUET trial patients were divided into 2 groups: one receiving etravirine plus a background regimen and the other receiving placebo alongside the same background regimen. The background drug regime included darunavir boosted by ritonavir and optimised nucleoside reverse transcriptase inhibitors, and in some cases, enfuvirtide. Baseline characteristics and demographics were comparable between treatment groups. Both patient groups were divided into 3 similar subgroups to isolate enfuvirtide from the rest of the background treatment combination. In each group, one set of patients took enfuvirtide for the first time, the second repeated the use of the drug, and the third did not take it. The researchers were able to determine that enfuvirtide -- along with baseline viral load, CD4-positive cell count, and a number of sensitive background antiretroviral medications -- was a predictor of response in both treatment groups. Dr. Cahn reported that 53% (37 of 70) of black patients who added etravirine to their treatment regimen achieved an undetectable viral load using the 50 copies/mL assay compared with 34% (24 of 70) of black patients who were treated with an optimised background of drugs (P = .0150). In Caucasians, 61% (228 of 373) of patients on etravirine achieved undetectable viral loads compared with 42% (156 of 376) on optimised background therapy (P < .0001). In Hispanic patients, 57% (34 of 60) of patients on etravirine achieved undetectable viral loads compared with 36% (24 of 66) of patients on optimised background regimen (P = .0118). Study participants were 90% men with a median age of 45. The disease characteristics of study participants included: viral load of 4.8 log10 copies/mL; CD4-positive cell count of approximately 100 cells/mm3; about 12% hepatitis B or C coinfection; previous resistance to NNRTI medications; and greater or equal to 3 primary protease inhibitor mutations. Funding for this study was provided by Tibotec Pharmaceuticals Limited. [Presentation title: 48-Week Pooled Analysis of DUET-1 and DUET-2: The Impact of Baseline Characteristics on Virological Response to Etravirine. Abstract TUPE0047]
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