Dolutegravir和raltegravir antiretroviral-experienced, integrase-inhibitor-naive成人艾滋病毒:48周的结果随机,双盲,non-inferiority帆船的研究。
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卡恩P Pozniak AL Mingrone H, Shuldyakov,英国人C, Andrade-Villanueva摩根富林明,里士满G,温迪亚CB, Fourie J, Ramgopal M, Hagins D, F Felizarta, Madruga J,路透社T,纽曼T, CB, Lombaard J, Grinsztejn B, Dorey D,安德伍德,格里菲斯,分钟
Dolutegravir和raltegravir antiretroviral-experienced, integrase-inhibitor-naive成人艾滋病毒:48周的结果随机,双盲,non-inferiority帆船的研究。
柳叶刀》。2013年8月24日,382 (9893):700 - 8。doi: 10.1016 / s0140 - 6736 (13) 61221 - 0。Epub 2013 7月3。
- PubMed ID
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23830355 (在PubMed]
- 文摘
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背景:Dolutegravir (GSK1349572),每日一HIV整合酶抑制剂,已显示出强大的抗病毒反应以及优惠的安全性。我们评估安全、功效和紧急antiretroviral-experienced阻力,integrase-inhibitor-naive成年人与至少两种耐药hiv - 1。方法:ING111762(航行)是一个48周,阶段3,随机,双盲,active-controlled, non-inferiority研究开始于2010年10月,。符合条件的患者连续两个血浆hiv - 1 RNA的评估400拷贝/毫升或更高(除非在筛选> 1000拷贝/毫升),两个或两个以上的阻力类抗逆转录病毒药物,和有一个为背景两种完全积极的药物治疗。参与者被随机分配(1:1)每日一次dolutegravir 50毫克或每天raltegravir 400毫克,investigator-selected背景治疗。匹配的安慰剂,和学习网站是蒙面的治疗任务。主要终点是患者血浆hiv - 1 RNA的比例小于50 48周后拷贝/毫升,评估在所有参与者随机分配到治疗组接受至少一个研究药物的剂量,不包括参与者在一个站点违反良好的临床实践。Non-inferiority预定的12%的保证金;如果non-inferiority成立,那么优势就会测试每一个预定的顺序测试过程。一个关键判断二次端点是治疗诱发的整合酶抑制剂的患者的比例阻力。 The trial is registered at ClinicalTrials.gov, NCT01231516. FINDINGS: Analysis included 715 patients (354 dolutegravir; 361 raltegravir). At week 48, 251 (71%) patients on dolutegravir had HIV-1 RNA less than 50 copies per mL versus 230 (64%) patients on raltegravir (adjusted difference 7.4%, 95% CI 0.7 to 14.2); superiority of dolutegravir versus raltegravir was then concluded (p=0.03). Significantly fewer patients had virological failure with treatment-emergent integrase-inhibitor resistance on dolutegravir (four vs 17 patients; adjusted difference -3.7%, 95% CI -6.1 to -1.2; p=0.003). Adverse event frequencies were similar across groups; the most commonly reported events for dolutegravir versus raltegravir were diarrhoea (71 [20%] vs 64 [18%] patients), upper respiratory tract infection (38 [11%] vs 29 [8%]), and headache (33 [9%] vs 31 [9%]). Safety events leading to discontinuation were infrequent in both groups (nine [3%] dolutegravir, 14 [4%] raltegravir). INTERPRETATION: Once-daily dolutegravir, in combination with up to two other antiretroviral drugs, is well tolerated with greater virological effect compared with twice-daily raltegravir in this treatment-experienced patient group. FUNDING: ViiV Healthcare.
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