Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study
Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study
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DOI：
10.1097/qad.0b013e32833a608a
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发表时间：
2010-07-01
期刊：
影响因子：
3.8
通讯作者：
Gatell, Jose M.
中科院分区：
文献类型：
--
作者：
Martinez, Esteban;Larrousse, Maria;Gatell, Jose M.
背景：在接受利托那韦增强蛋白酶抑制剂治疗的患者中，切换到雷替格拉韦可能会导致相似的疗效和较低的血脂。方法：螺旋是一项为期48周的多中心、开放标签试验，在该试验中，至少在前6个月接受利托那韦增强的蛋白酶抑制剂治疗的血浆HIV RNA少于50拷贝/ml的HIV感染成人随机（1:1）从利托那韦增强的蛋白酶抑制剂切换到雷替重力韦或继续接受利托那韦增强的蛋白酶抑制剂治疗。主要终点是48周无治疗失败（未完成=失败）的患者比例。螺旋研究显示，以替地韦为基础的治疗的有效性为-12.5%。结果：273名患者被纳入疗效分析，他们被分配到改用雷替格拉韦（n=139）或继续使用利托那韦增强的蛋白酶抑制剂（n=134）。在48周时，89.2%的患者（以雷替重力韦为基础的治疗）和86.6%的患者（利托那韦增强的蛋白酶抑制剂为基础的治疗）仍然没有治疗失败[差异2.6%；95%置信区间(CI) -5.2至10.6]。共有96.9%的患者（以雷替格拉韦为基础的治疗）和95.1%的患者（利托那韦增强的蛋白酶抑制剂为基础的治疗）没有出现病毒学失败（差异1.8%;95% CI -3.5至7.5）。与继续使用利托那韦增强蛋白酶抑制剂相比，改用雷替格拉韦可显著降低血浆脂质和总胆固醇与高密度脂蛋白胆固醇之比。两组中分别有4%和2%的患者发生严重不良事件和因任何不良事件而停药。结论：在持续接受利托那韦增强蛋白酶抑制剂治疗的病毒学抑制的患者中，从利托那韦增强蛋白酶抑制剂切换到雷替格雷韦显示出非劣效，并且在48周时比继续使用利托那韦增强蛋白酶抑制剂产生更好的脂质谱。(C) 2010年Wolters Kluwer Health垂直条Lippincott Williams & Wilkins
Background: Switching to raltegravir in selected patients treated with ritonavir-boosted protease inhibitors may result in similar efficacy and lower plasma lipids.Methods: SPIRAL is a 48-week multicentre, open-label trial in which HIV-infected adults with less than 50 copies/ml of plasma HIV RNA for at least the previous 6 months on ritonavir-boosted protease inhibitor-based therapy were randomized (1 : 1) to switch from the ritonavir-boosted protease inhibitor to raltegravir or to continue on ritonavir-boosted protease inhibitor-based therapy. Primary endpoint was the proportion of patients free of treatment failure (noncompleter=failure) at 48 weeks. SPIRAL study was powered to show noninferior efficacy of raltegravir-based therapy with a margin of -12.5%.Results: Two hundred and seventy-three patients assigned to switch to raltegravir (n=139) or to continue ritonavir-boosted protease inhibitor (n=134) were included in the efficacy analysis. At 48 weeks, 89.2% (raltegravir-based therapy) and 86.6% (ritonavir-boosted protease inhibitor-based therapy) of the patients remained free of treatment failure [difference 2.6%; 95% confidence interval (CI) -5.2 to 10.6]. A total of 96.9% (raltegravir-based therapy) and 95.1% (ritonavir-boosted protease inhibitor-based therapy) of the patients remained free of virological failure (difference 1.8%; 95% CI -3.5 to 7.5). Switching to raltegravir was associated with significant decreases in plasma lipids and total-to-HDL cholesterol ratio relative to continuing ritonavir-boosted protease inhibitor. Severe adverse events and study drug discontinuations due to any adverse event occurred in 4 and 2% of the patients in each group.Conclusion: In patients with sustained virological suppression on ritonavir-boosted protease inhibitor-based therapy, switching from ritonavir-boosted protease inhibitor to raltegravir demonstrated noninferior efficacy and resulted in a better lipid profile at 48 weeks than continuing ritonavir-boosted protease inhibitor. (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins