Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials

被引:93
作者
Katlama, Christine [1 ,2 ]
Clotet, Bonaventura [3 ,4 ]
Mills, Anthony
Trottier, Benoit [5 ]
Molina, Jean-Michel [6 ,7 ]
Grinsztejn, Beatriz [8 ]
Towner, William [9 ]
Haubrich, Richard [10 ]
Nijs, Steven [11 ]
Vingerhoets, Johan [11 ]
Woodfall, Brian [11 ]
Witek, James [12 ]
机构
[1] Univ Paris 06, Paris 6, France
[2] Hop La Pitie Salpetriere, Serv Malad Infect & Trop, Paris, France
[3] Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
[4] IrsiCaixa Fdn, Barcelona, Spain
[5] Clin Med Actuel, Montreal, PQ, Canada
[6] Hop St Louis, Serv Malad Infect & Trop, Paris, France
[7] Univ Paris Diderot, Paris 7, France
[8] Inst Pesquisa Clin Evandro Chagas Fiocruz, Rio De Janeiro, Brazil
[9] Kaiser Permanente, Los Angeles, CA USA
[10] Univ Calif San Diego, Div Infect Dis, San Diego, CA 92103 USA
[11] Tibotec BVBA, Beerse, Belgium
[12] Tibotec Inc, Titusville, NJ USA
关键词
PLACEBO-CONTROLLED TRIAL; HIV-1-INFECTED PATIENTS; TMC125; ETRAVIRINE; DOUBLE-BLIND;
D O I
10.3851/IMP1662
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Background: Durable efficacy and long-term safety of antiretroviral therapy are important goals in the management of treatment-experienced patients. The 96-week efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine were evaluated in the Phase Ill DUET trials. Methods: HIV type-1-infected treatment-experienced adults with viral loads >5,000 copies/ml and NNRTI and protease inhibitor resistance were randomized to receive etravirine 200 mg or placebo, each twice daily and in combination with a background regimen of darunavir/ritonavir twice daily, nucleoside/nucleotide reverse transcriptase inhibitors and optional enfuvirtide. The primary end point was the proportion of patients with viral load <50 copies/ml (intent-to-treat analysis, time-to-loss of virological response algorithm) at week 24. Results from both trials were combined in the pre-specified pooled 96-week analysis. Results: In total, 599 patients received etravirine and 604 received placebo. At week 96, 57% of patients in the etravirine group versus 36% in the placebo group had a viral load <50 copies/ml (P<0.0001); 91% and 88% of patients, respectively, had maintained this response from week 48. Mean increases in CD4(+) T-cell count from baseline at week 96 were 128 cells/mm(3) with etravirine versus 86 cells/mm3 with placebo (P<0.0001). With the exception of rash, which was reported more frequently with etravirine than placebo (21% versus 12%, respectively; P<0.0001), the safety and tolerability profile of etravirine was similar to placebo over the treatment period. Conclusions: Etravirine, in combination with an antiretroviral background regimen, provided durable virological and immunological responses with no new safety concerns in treatment-experienced patients over 96 weeks in the DUET trials.
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收藏
页码:1045 / 1052
页数:8
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