University of Minnesota, Minneapolis, MN, USA.
J Acquir Immune Defic Syndr. 2011 Jan 1;56(1):36-43. doi: 10.1097/QAI.0b013e3181f7f61a.
Among a subgroup of participants in the Strategies for Management of Antiretroviral Therapy (SMART) Trial that were naïve to antiretroviral therapy (ART) or off ART (6 months or longer) at study entry, risk of AIDS and serious non-AIDS events were increased for participants who deferred ART compared with those randomized to (re)initiate ART immediately. Our objective was to determine whether ART initiation in this group reduced markers of inflammation and coagulation that have been associated with increased mortality risk in SMART. Changes in these biomarkers have been described after stopping ART, but not after starting ART in SMART.
Stored specimens for 254 participants (126 drug conservation [DC] and 128 viral suppression [VS]) who were naïve to ART or off ART (6 months or longer) were analyzed for interleukin-6, high sensitivity C-reactive protein, and D-dimer at baseline and Months 2 and 6.
At Month 6, 62% of the VS group had HIV RNA less than 400 copies/mL and median CD4 count was 190 cells/mm3 higher than for the DC group (590 versus 400 cells/mm3). Compared with DC, the VS group had 32% (95% confidence interval, 19%-43%) lower D-dimer levels at Month 6 (P < 0.001); differences were not significant for high sensitivity C-reactive protein or interleukin-6 levels.
In this randomized comparison of immediate versus delayed ART initiation, D-dimer, but not interleukin-6 and high sensitivity C-reactive protein, declined significantly after starting ART. Further studies are needed to determine whether improvements in D-dimer are associated with reduced risk of clinical disease and whether adjunct treatments used in combination with ART can reduce inflammation among individuals with HIV infection.
在 Strategies for Management of Antiretroviral Therapy（SMART）试验中，一组初次接受抗逆转录病毒治疗（ART）或停药（6 个月或更长时间）的参与者中，与随机接受（重新）开始 ART 的参与者相比，延迟 ART 的参与者发生艾滋病和严重非艾滋病事件的风险增加。我们的目的是确定在这一组中启动 ART 是否会降低与 SMART 中死亡率风险增加相关的炎症和凝血标志物。这些生物标志物在停止 ART 后已经得到描述，但在 SMART 中开始 ART 后尚未得到描述。
对 254 名初次接受 ART 或停药（6 个月或更长时间）的参与者（126 名药物保留[DC]和 128 名病毒抑制[VS]）的储存标本进行分析，以评估白细胞介素-6、高敏 C 反应蛋白和 D-二聚体在基线和第 2 个月和第 6 个月时的水平。
在第 6 个月时，VS 组有 62%的人 HIV RNA 小于 400 拷贝/mL，CD4 计数中位数比 DC 组高 190 个细胞/mm3（590 与 400 个细胞/mm3）。与 DC 组相比，VS 组在第 6 个月时 D-二聚体水平低 32%（95%置信区间，19%-43%）（P<0.001）；高敏 C 反应蛋白或白细胞介素-6 水平的差异无统计学意义。
在这项关于立即与延迟启动 ART 的随机比较中，在开始 ART 后，D-二聚体而不是白细胞介素-6 和高敏 C 反应蛋白显著下降。需要进一步研究以确定 D-二聚体的改善是否与降低临床疾病风险相关，以及在 HIV 感染个体中与 ART 联合使用的辅助治疗是否可以降低炎症。
