The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml
The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml
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DOI：
10.1097/qad.0b013e3283348944
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发表时间：
2010-01-01
期刊：
影响因子：
3.8
通讯作者：
Moecklinghoff, Christiane
中科院分区：
文献类型：
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作者：
Arribas, Jose R.;Horban, Andrzej;Moecklinghoff, Christiane
背景：在病毒学抑制的患者中，达鲁那韦-利托那韦(darunavir-ritonavir，DRV/r)的单一治疗可以维持与DRV/r和两个核苷类似的病毒学抑制。方法：256名HIVRNA<50拷贝/毫升的患者在使用现有抗逆转录病毒药物[基于非核苷类逆转录酶抑制剂(NNRTI)(43%)，或基于蛋白酶抑制剂(Protease Inhibitor)(57%)]超过24周后，每天改用DRV/r800/100 mg，作为单一治疗(n=127)或使用两种核苷逆转录酶抑制剂(n=129)(n=129)。治疗失败被定义为在48周前连续两次HIV RNA水平超过50拷贝/毫升(TLOVR)，或停止研究治疗。结果：患者中81%为男性，91%为高加索人，平均年龄为44岁，CD_4细胞数为574个/亩L。在初步疗效分析中，48周时HIVRNA<50拷贝/毫升(按方案)为86.2%，而单一治疗组和三联治疗组为87.8%；按意向治疗切换等于失败，有效率为84.3%对85.3%；通过包含Switch的分析，有效率分别为93.5%和95.1%：三项比较均显示DRV/r单一疗法的疗效并不逊色。在试验期间，两组患者的CD4细胞计数都保持稳定。每支手臂有一名患者表现出至少一种蛋白酶抑制剂突变，三联疗法组有一名患者表现出NRTI突变。每支手臂有9名患者因不良事件或其他原因而停止随机治疗。没有检测到新的或意想不到的安全信号。结论：在这项研究中，对于使用其他抗逆转录病毒药物的HIV RNA低于50拷贝/毫升的患者，改用DRV/r单一疗法与三种抗逆转录病毒疗法相比，疗效并不逊色。(C)2010年Wolters Kluwer Health垂直酒吧Lippincott Williams&Wilkins
Background: In virologically suppressed patients, darunavir-ritonavir (DRV/r) monotherapy could maintain virological suppression similarly to DRV/r and two nucleosides.Methods: Two hundred and fifty-six patients with HIV RNA less than 50 copies/ml for over 24 weeks on current antiretrovirals [non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (43%), or protease inhibitor-based (57%)], switched to DRV/r 800/100 mg once daily, either as monotherapy (n = 127) or with two nucleoside reverse transcriptase inhibitors (NRTIs) (n=129). Treatment failure was defined as two consecutive HIV RNA levels above 50 copies/ml (TLOVR) by week 48, or switches off study treatment. The trial had 80% power to show noninferiority for the monotherapy arm (delta = -12%).Results: Patients were 81% male and 91% Caucasian, with mean age 44 years, and CD4 cell count of 574 cells/mu l. In the primary efficacy analysis, HIV RNA less than 50 copies/ml by week 48 (per protocol) was 86.2 versus 87.8% in the monotherapy and triple therapy arms; by intent-to-treat switch equals failure, efficacy was 84.3 versus 85.3%; by a switch-included analysis, efficacy was 93.5 versus 95.1%: all three comparisons showed noninferior efficacy for DRV/r monotherapy. CD4 cell counts remained stable during the trial in both arms. One patient per arm showed at least one protease inhibitor mutation, and one patient in the triple therapy arm showed an NRTI mutation. Nine patients per arm discontinued randomized treatment for either adverse events or other reasons. No new or unexpected safety signals were detected.Conclusions: In this study for patients with HIV RNA less than 50 copies/ml on other antiretrovirals at baseline, switching to DRV/r monotherapy showed noninferior efficacy versus triple antiretroviral therapy. (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins