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首页> 外文期刊>AIDS >Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136.
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Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136.

机译：darunavir / ritonavir维持单一疗法在HIV-1病毒抑制患者中的疗效：一项开放性，非劣效性随机试验，MONOI-ANRS 136。

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BACKGROUND: Darunavir/ritonavir (darunavir/r) maintenance strategy, in patients with suppressed HIV RNA viremia, is a potential long-term strategy to avoid nucleoside analogue toxicities and to reduce costs. METHODS: MONOtherapy Inhibitor protease is a prospective, open-label, noninferiority, 96-week safety and efficacy trial in virologically suppressed patients on triple therapy who were randomized to a darunavir/r triple drug regimen or darunavir/r monotherapy. The primary endpoint was the proportion of patients with HIV RNA less than 400 copies/ml at week 48; treatment failure was defined as two consecutive HIV RNA more than 400 copies/ml (time to loss of virologic response) or any change in treatment. The trial had 80% power to show noninferiority for the monotherapy arm (delta =-10%, 90% confidence interval). RESULTS: A total of 242 patients were screened, 225 of whom were randomized. In the per protocol efficacy analysis, treatment success was 99% on darunavir/r triple drug versus 94% on darunavir/r monotherapy (delta = -4.9%, 90% confidence interval, from -9.1 to -0.8). Similar results were found in intent-to-treat population (92 versus 87.5%, delta = -4.5%, 90% confidence interval from -11.2 to 2.1). Three patients experienced virologic failure on darunavir/monotherapy and none on darunavir/r triple drug. No resistance to protease inhibitor emerged in patients with plasma viral load above 50 copies/ml. The two groups did not differ in the number of serious adverse events. CONCLUSION: Darunavir/r monotherapy exhibited efficacy rate over 85% with concordant results in the magnitude of difference with darunavir/r triple drug regimen in both intent-to-treat and per protocol analyses, but discordant conclusions with respect to the noninferiority margin. Patients failing on darunavir/r monotherapy had no emergence of new darunavir resistance mutations preserving future treatment options.
机译：背景：在被抑制的HIV RNA病毒血症患者中，达鲁那韦/利托那韦（darunavir / r）维持策略是避免核苷类似物毒性并降低成本的潜在长期策略。方法：MONOtherapy抑制剂蛋白酶是一项前瞻性，开放性，非劣效性，为期96周的安全性和有效性试验，用于接受病毒学抑制的三联疗法患者，这些患者随机接受darunavir / r三联疗法或darunavir / r单一疗法。主要终点是第48周时HIV RNA低于400拷贝/ ml的患者比例。治疗失败的定义是连续两次HIV RNA大于400拷贝/ ml（失去病毒学应答的时间）或治疗发生任何变化。该试验有80％的能力显示出单药治疗组的非劣效性（差异= -10％，置信区间为90％）。结果：共筛选了242例患者，其中225例被随机分组​​。在按方案进行的疗效分析中，darunavir / r三联疗法的治疗成功率为99％，而darunavir / r单药疗法的治疗成功率为94％（δ= -4.9％，90％置信区间，从-9.1至-0.8）。在意向性治疗人群中发现了相似的结果（92对87.5％，delta = -4.5％，从-11.2到2.1的置信区间为90％）。 3例患者在darunavir /单药治疗中发生了病毒学衰竭，而在darunavir / r三联药物治疗中无一例。血浆病毒载量高于50拷贝/ ml的患者对蛋白酶抑制剂没有抵抗力。两组的严重不良事件数量没有差异。结论：Darunavir / r单一疗法在意向性治疗和按方案分析中均显示与darunavir / r三药方案的差异程度一致，但在非劣效性方面的结论不一致。 darunavir / r单药治疗失败的患者未出现新的darunavir耐药性突变，从而保留了未来的治疗选择。

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