BACKGROUND Genetic divergence of HIV-1/O relative to HIV-1/M impacts virological monitoring and drug susceptibility, but little is known about impact on therapeutic outcomes. We aimed to determine if responses to standardized cART were similar between groups despite strain divergence. METHODS We performed an open non-randomized study comparing the immunological, virological and clinical responses to cART based on 2NRTIs+1PI/r, in naive and paired HIV-1/O- versus HIV-1/M-infected patients (ratio 1:2), matched on sex, age, CD4 count, hemoglobin level, and HBsAg status. The primary endpoint was the proportion of patients with undetectable plasma viral load (pVL, threshold 60 cp/mL) at W48. Secondary endpoints were the proportion of patients with undetectable pVL at W24 and W96 and CD4 evolution between baseline and W24, W48 and W96. RESULTS 47 HIV-1/O and 94 HIV-1/M patients were included. Mean pVL at baseline was significantly lower by 1 log for HIV-1/O versus HIV-1/M patients. At W48, no significant difference was observed between populations with undetectable pVL in 80.9% of HIV-1/O versus 75.5% of HIV-1/M patients. Differences at W24 and W96 were not significant. A difference in CD4 gain was observed in favor of HIV-1/M at W48 and W96, but this was not significant when adjusted on both matched criteria and pVL at baseline. CONCLUSIONS Our data demonstrate similar immuno-virological and clinical response between HIV-1/O and HIV-1/M patients, suggesting that genetic divergence does not impact therapeutic outcomes. They also reveal significantly lower baseline replication for HIV-1/O variants, suggesting specific virological properties and physiopathology that now need to be addressed. CLINICAL TRIALS REGISTRATION NCT00658346.

中文翻译：

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HIV-1组O-和HIV-1组M感染的患者对抗逆转录病毒疗法的比较免疫病毒学和临床反应（ANRS 12168 DynaMO研究）。

背景技术HIV-1 / O相对于HIV-1 / M的遗传差异会影响病毒学监测和药物敏感性，但对治疗效果的影响知之甚少。我们旨在确定尽管菌株存在差异，但两组之间对标准化cART的反应是否相似。方法我们进行了一项开放非随机研究，比较了在未感染和成对的HIV-1 / O-与HIV-1 / M感染的患者中，基于2NRTIs + 1PI / r对cART的免疫，病毒学和临床反应（比率1： 2），在性别，年龄，CD4计数，血红蛋白水平和HBsAg状态上相匹配。主要终点是在第48周时血浆病毒载量（pVL，阈值60 cp / mL）无法检测的患者比例。次要终点是基线和W24，W48和W96之间在W24和W96时检测不到pVL的患者比例和CD4演变。结果纳入47例HIV-1 / O和94例HIV-1 / M患者。与HIV-1 / M患者相比，HIV-1 / O基线的平均pVL显着降低了1 log。在第48周，在80.9％的HIV-1 / O患者与75.5％的HIV-1 / M患者中，未检测到pVL的人群之间没有观察到显着差异。W24和W96的差异不明显。在第48周和第96周，观察到CD4增益的差异有利于HIV-1 / M，但是当根据匹配的标准和基线的pVL进行调整时，这并不显着。结论我们的数据表明HIV-1 / O和HIV-1 / M患者之间具有相似的免疫-病毒学和临床反应，这表明遗传差异不会影响治疗结果。他们还发现HIV-1 / O变异的基线复制明显降低，建议现在需要解决的特定病毒学特性和生理病理学。临床试验注册NCT00658346。