Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.
Directly observed therapy (DOT) for antiretroviral therapy (ART) may improve adherence, but there are limited data on its clinical effectiveness.
Adult patients initiating ART in a public clinic in Cape Town, South Africa, were randomized to treatment-supporter DOT-ART or self-administered ART. DOT-ART patients and supporters received baseline and follow-up training and monitoring. The primary endpoints were the proportions of patients with HIV viral load less than 400 copies/ml and change in CD4 cell counts at 12 and 24 months.
Two hundred and seventy-four patients enrolled (137 in each arm) and baseline characteristics were similar for both arms. The study was stopped early for futility by an independent Data and Safety Monitoring Board. In an intention-to-treat analysis, the proportions of patients with viral load less than 400 copies/ml at 12 months were 72.8% in the DOT-ART arm and 68.4% in the Self-ART arm (P = 0.42). DOT-ART patients had greater median CD4 cell count (cells/microl) increases at 6 months [148 (IQR 84-222) vs. 111 (IQR 44-196) P = 0.02] but similar results at all other time-points. Survival was significantly better in the DOT-ART arm (9 deaths, 6.6%) than in the Self-ART arm (20 deaths, 14.6%; log-rank P = 0.02). In Cox regression analysis, mortality was independently associated with study arm [DOT vs. self-ART; HR 0.38, 95% confidence interval (CI) 0.17-0.86].
DOT-ART showed no effect on virologic outcomes but was associated with greater CD4 cell count increases at 6-month follow-up. Survival was significantly better for DOT-ART compared to Self-ART, but this was not explained by improved virologic or immunologic outcomes.
直接观察治疗(DOT)用于抗逆转录病毒治疗(ART)可能会提高治疗依从性,但关于其临床效果的数据有限。
在南非开普敦的一家公立诊所接受 ART 治疗的成年患者被随机分配到治疗支持者 DOT-ART 或自我管理的 ART 组。DOT-ART 患者和支持者接受了基线和随访培训和监测。主要终点是 HIV 病毒载量小于 400 拷贝/ml 的患者比例和 12 个月和 24 个月时 CD4 细胞计数的变化。
274 名患者入组(每组 137 名),两组的基线特征相似。独立的数据和安全监测委员会因无效性而提前停止了研究。在意向治疗分析中,12 个月时病毒载量小于 400 拷贝/ml 的患者比例,DOT-ART 组为 72.8%,自我管理 ART 组为 68.4%(P=0.42)。DOT-ART 患者在 6 个月时 CD4 细胞计数(细胞/微升)中位数增加更多[148(IQR 84-222)比 111(IQR 44-196),P=0.02],但在所有其他时间点的结果相似。DOT-ART 组的生存率明显高于自我管理 ART 组(9 例死亡,6.6%)比自我管理 ART 组(20 例死亡,14.6%;对数秩检验 P=0.02)。在 Cox 回归分析中,死亡率与研究组独立相关[DOT 与自我管理 ART;HR 0.38,95%置信区间(CI)0.17-0.86]。
DOT-ART 对病毒学结果没有影响,但与 6 个月随访时 CD4 细胞计数增加有关。与自我管理 ART 相比,DOT-ART 的生存率显著提高,但这不能用病毒学或免疫学结果的改善来解释。