Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection.
Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection.
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DOI：
10.1056/evidoa2200302
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发表时间：
2023-03
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对于CD4+计数低于500细胞/mm3的艾滋病毒感染者，与推迟治疗至CD4+计数低于350细胞/mm3相比，早期开始抗逆转录病毒治疗（ART）可降低严重艾滋病和严重非艾滋病（SNA）风险。对于那些推迟治疗的人，一旦开始抗逆转录病毒治疗，艾滋病和SNA的过度风险是否仍然存在尚不确定。如先前报道的，抗逆转录病毒治疗的战略时机（START）试验随机分配了4684名CD4+计数的抗逆转录病毒治疗初期hiv阳性成人。500个细胞/mm3随机分配后立即开始治疗（n= 2325）或延迟治疗（n= 2359）。2015年，据报道，直接治疗组的主要终点（艾滋病、SNA或死亡）风险降低了57%，并向延迟治疗组提供了抗逆转录病毒治疗。本文报道了持续到2021年12月31日的后续行动。Cox比例风险模型用于比较从随机化到2015年12月31日与2016年1月1日至2021年12月31日的主要终点的风险比。截至2015年12月31日，在上一次报告截止日期后约7个月，在治疗开始时，立即治疗组和延迟治疗组的中位CD4+计数分别为648和460细胞/mm3。立即治疗组和延迟治疗组接受ART治疗的随访时间分别为95%和36%，时间平均CD4+差异为199个细胞/mm3。2016年1月1日后，立即治疗组和延迟治疗组的治疗随访时间分别为97.2%和94.1%，CD4+计数差异为155个细胞/mm3。2016年1月1日之后，2016年之前共有89名即时组参与者和113名延迟组参与者经历了一个主要终点（风险比为0.79[95%置信区间，0.60至1.04]，而风险比为0.47[95%置信区间，0.34至0.65，P<0.001]）（风险比差异P=0.02）。在CD4+计数为500cells /mm3的成年人中，与延迟开始治疗相关的艾滋病和SNA的过度风险在抗逆转录病毒治疗开始后减少，但持续的过度风险仍然存在。（由国家过敏和传染病研究所和其他机构资助。）
For people with HIV and CD4+ counts >500 cells/mm3, early initiation of antiretroviral therapy (ART) reduces serious AIDS and serious non-AIDS (SNA) risk compared with deferral of treatment until CD4+ counts are <350 cells/mm3. Whether excess risk of AIDS and SNA persists once ART is initiated for those who defer treatment is uncertain. The Strategic Timing of AntiRetroviral Treatment (START) trial, as previously reported, randomly assigned 4684 ART-naive HIV-positive adults with CD4+ counts .500 cells/mm3 to immediate treatment initiation after random assignment (n = 2325) or deferred treatment (n= 2359). In 2015, a 57% lower risk of the primary end point (AIDS, SNA, or death) for the immediate group was reported, and the deferred group was offered ART. This article reports the follow-up that continued to December 31, 2021. Cox proportional-hazards models were used to compare hazard ratios for the primary end point from randomization through December 31, 2015, versus January 1, 2016, through December 31, 2021. Through December 31, 2015, approximately 7 months after the cutoff date from the previous report, the median CD4+ count was 648 and 460 cells/mm3 in the immediate and deferred groups, respectively, at treatment initiation. The percentage of follow-up time spent taking ART was 95% and 36% for the immediate and deferred groups, respectively, and the time-averaged CD4+ difference was 199 cells/mm3. After January 1, 2016, the percentage of follow-up time on treatment was 97.2% and 94.1% for the immediate and deferred groups, respectively, and the CD4+ count difference was 155 cells/mm3. After January 1, 2016, a total of 89 immediate and 113 deferred group participants experienced a primary end point (hazard ratio of 0.79 [95% confidence interval, 0.60 to 1.04] versus hazard ratio of 0.47 [95% confidence interval, 0.34 to 0.65; P<0.001]) before 2016 (P=0.02 for hazard ratio difference). Among adults with CD4+ counts >500 cells/mm3, excess risk of AIDS and SNA associated with delaying treatment initiation was diminished after ART initiation, but persistent excess risk remained. (Funded by the National Institute of Allergy and Infectious Diseases and others.)