Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study.
Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study.
复制标题
达芦那韦/利托那韦单一疗法对 HIV-1 病毒抑制患者的长期疗效：MONOI ANRS 136 研究第 96 周的结果。
DOI：
10.1093/jac/dkr504
复制
发表时间：
2012
期刊：
影响因子：
--
通讯作者：
C. Katlama
中科院分区：
文献类型：
--
作者：
M. Valantin;S. Lambert;P. Flandre;L. Morand‐Joubert;A. Cabié;J. Meynard;D. Ponscarme;F. Ajana;L. Slama;A. Curjol;L. Cuzin;L. Schneider;A. Taburet;A. Marcelin;C. Katlama
目标
需要96周的长期结果来评价地瑞那韦/利托那韦单药治疗策略维持HIV-1病毒载量持续控制的能力。
方法
MONOI是一项前瞻性、开放标签、非劣效性、随机、96周试验，比较了地瑞那韦/利托那韦单药治疗与地瑞那韦/利托那韦三联治疗策略在HIV-1感染患者中维持HIV-1病毒载量抑制的效果。
临床试验注册
NCT 00412551。
结果
在225例随机化患者中，219例患者达到了48周随访，211例达到了96周随访（地瑞那韦单药治疗组106例患者，地瑞那韦三联治疗组105例患者）。两个治疗组之间的基线特征平衡良好。在第96周，在意向治疗分析中，分配到地瑞那韦/利托那韦单药治疗组的91/103例患者（88%，95%CI 81-94）和分配到地瑞那韦三联治疗组的87/104例患者（84%，95%CI 75-90）达到HIV-1病毒载量<50拷贝/mL，两组之间无统计学差异。在整个96周随访期间，地瑞那韦/利托那韦单药治疗组和地瑞那韦/利托那韦三联治疗组分别有66/112例患者（59%，95%CI 49-68）和79/113例患者（70%，95%CI 61-78）的HIV-1 RNA始终<50拷贝/mL。
结论
MONOI研究确定了地瑞那韦/利托那韦单药治疗在维持HIV-1患者病毒学抑制方面的持久性和有效性。达芦那韦/利托那韦单药治疗应被视为一个（定制的）治疗选择标准三联疗法的患者谁有一个相当长的病毒抑制期。
OBJECTIVES
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.
METHODS
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.
CLINICAL TRIAL REGISTRATION
NCT00412551.
RESULTS
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.
CONCLUSIONS
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.