INSERM UMR-S 943 and University Pierre and Marie Curie (UPMC) Paris VI, Paris, France.
J Antimicrob Chemother. 2012 Mar;67(3):691-5. doi: 10.1093/jac/dkr504. Epub 2011 Dec 7.
Long-term results at week 96 are needed to evaluate the capacity of the darunavir/ritonavir monotherapy strategy to maintain a sustained control of the HIV-1 viral load.
MONOI is a prospective, open-label, non-inferiority, randomized, 96 week trial comparing darunavir/ritonavir monotherapy versus a darunavir/ritonavir triple-therapy strategy to maintain HIV-1 viral load suppression in HIV-1-infected patients.
NCT00412551.
From 225 randomized patients, 219 patients reached the 48 week follow-up and 211 reached the 96 week follow-up (106 patients in the darunavir monotherapy arm and 105 in the darunavir triple-therapy arm). Baseline characteristics were well balanced between the two treatment groups. At week 96, in intent-to-treat analysis, 91/103 patients (88%, 95% CI 81-94) allocated to the darunavir/ritonavir monotherapy arm and 87/104 patients (84%, 95% CI 75-90) allocated to the darunavir triple-therapy arm achieved an HIV-1 viral load <50 copies/mL, with no statistical difference between the two groups. Throughout the 96 week follow-up, 66/112 patients (59%, 95% CI 49-68) and 79/113 patients (70%, 95% CI 61-78) consistently had HIV-1 RNA <50 copies/mL with darunavir/ritonavir monotherapy and darunavir/ritonavir triple therapy, respectively.
The MONOI study establishes darunavir/ritonavir monotherapy as durable and efficacious for maintaining virological suppression in HIV-1 patients. Darunavir/ritonavir monotherapy should be considered as a (tailored) treatment option for standard triple-therapy patients who have had a substantial period of viral suppression.
需要评估达芦那韦/利托那韦单药治疗方案在第 96 周时维持 HIV-1 病毒载量持续控制的能力，以提供第 96 周的长期结果。
MONOI 是一项前瞻性、开放性、非劣效性、随机、96 周试验，比较达芦那韦/利托那韦单药治疗与达芦那韦/利托那韦三联治疗方案，以维持 HIV-1 感染患者的 HIV-1 病毒载量抑制。
NCT00412551。
在 225 名随机患者中，219 名患者达到 48 周随访，211 名患者达到 96 周随访（达芦那韦单药治疗组 106 名，达芦那韦三联治疗组 105 名）。两组患者的基线特征均衡。在意向治疗分析中，96 周时，103 名患者中的 91 名（88%，95%CI81-94）被分配到达芦那韦/利托那韦单药治疗组，104 名患者中的 87 名（84%，95%CI75-90）被分配到达芦那韦三联治疗组，实现了 HIV-1 病毒载量<50 拷贝/ml，两组之间无统计学差异。在整个 96 周随访中，112 名患者中的 66 名（59%，95%CI49-68）和 113 名患者中的 79 名（70%，95%CI61-78）分别持续使用达芦那韦/利托那韦单药和达芦那韦/利托那韦三联治疗，HIV-1 RNA<50 拷贝/ml。
MONOI 研究确立了达芦那韦/利托那韦单药治疗作为维持 HIV-1 患者病毒学抑制的持久有效治疗方法。对于已经有大量病毒抑制期的标准三联治疗患者，达芦那韦/利托那韦单药治疗应被视为一种（定制）治疗选择。
