48-Wee的k Results from BENCHMRK-2, a Phase III Study of Raltegravir.pptVIP

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2017-01-20 发布于北京
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48-Wee的k Results from BENCHMRK-2, a Phase III Study of Raltegravir.ppt

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Copyright ? 2008 Merck Co., Inc., Whitehouse Station, New Jersey, USA, All Rights Reserved 48-Week Results from BENCHMRK-2, a Phase III Study of Raltegravir (RAL) in Patients Failing Antiretroviral Therapy (ART) with Triple-Class Resistant HIV-1 R. Steigbigel1, P. Kumar2, J. Eron3, M. Schechter4, M. Markowitz5, M. Loutfy6, J. Zhao7, R. Isaacs7, B-Y. Nguyen7, H Teppler7 for the BENCHMRK-2 Study Group 1SUNY at Stony Brook, USA; 2Georgetown University Medical Center, Washington, DC, USA; 3University of North Carolina, USA; 4Univ Fed de Rio de Janeiro, Brazil; 5Aaron Diamond Research Center, NY, USA; 6University of Toronto, Canada; 7Merck Research Laboratories, West Point, PA, USA. Raltegravir (MK-0518, ISENTRESSTM), an HIV-1 integrase strand-transfer inhibitor (InSTI) Potent in vitro activity: IC95 = 31 nM ? 20 nM (50% human serum) Active against multi-drug resistant HIV-1, CCR5 and CXCR4 tropic HIV-1 HIV resistant to raltegravir remains sensitive to other ARTs Additive/synergistic with NRTIs, NNRTIs, PIs, and enfuvirtide Clinical efficacy when used in combination with OBT: in ART-naive patients, 83 – 88% had HIV RNA 50 copies/mL at week 48 (Markowitz et al, JAIDS 2007; 46:125-33) In patients failing therapy with triple class resistant virus: 56 – 67% had HIV RNA 50 copies/mL at Week 24 in the phase II dose-ranging study (Grinsztejn et al, LANCET 2007; 369:1261–69) 63% had HIV RNA 50 copies/mL at Week 24 in the phase III BENCHMRK-1 and 2 studies combined (Kumar et al, EACS Oct 2007) BENCHMRK-1 -2 Study Design Randomized, double-blind, placebo-controlled with Data and Safety Monitoring Board Primary analysis at Week 16; secondary analysis at Week 48 Statistical Analysis The durability of antiretroviral and immunological activity was assessed by the following predefined endpoints measured at Week 48: HIV RNA 50 copies/mL, HIV RNA 400 copies/mL, change from baseline in plasma HIV RNA (log10 copies/mL), and change from baseline in CD4 cell cou