Early versus deferred antiretroviral therapy initiation and long-term cardiovascular disease outcomes in people with HIV: The START study.

IF 3.8 4区医学 Q2 IMMUNOLOGY

Open Forum Infectious Diseases Pub Date : 2025-09-15 eCollection Date: 2025-09-01 DOI:10.1093/ofid/ofaf561

Nila J Dharan, Shweta Sharma, Alejandro Arenas-Pinto, Daniel Duprez, Vicente Estrada, Karen Ha, Mariana Angelica Kundro, Rosie Mngqibisa, Henry Mugerwa, David Munroe, Rakan Nasreddine, Tess E Peterson, Irini Sereti, Janine M Trevillyan, Jason V Baker, Gail V Matthews, Andrew N Phillips

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引用次数: 0

Abstract

Background: It is unknown whether delayed antiretroviral therapy (ART) initiation worsens CVD outcomes in people with HIV (PHIV). This study compared CVD event rates between PHIV who were randomized to receive immediate versus deferred ART.

Methods: ART-naïve adult PHIV with CD4+ counts > 500 cells/µL were randomized to immediate versus deferred ART initiation. Event rates for the main composite CVD outcome (myocardial infarction, coronary artery disease requiring revascularization, stroke and CVD-related death) were estimated for: (i) pre-2016 (treatment arms as designed); (ii) post-1Jan2016 (ART use similar across arms); and (iii) entire study follow-up period. Subgroup analyses were performed according to baseline characteristics.

Results: Among 4684 participants (median age 36 years, 27% female, 30% Black race), 32% were smokers and 17% had a BMI ≥ 30 kg/m². Comorbidities included hypertension (19%), dyslipidemia (8%), diabetes (3%); 0.8% had a history of CVD. The median time to ART initiation was 2.5 years (interquartile range [IQR] 1.6-3.5 years) in the deferred arm and 7 days (IQR 2-17 days) in the immediate arm. Over the entire study follow-up period (median follow-up of 9.3 years), 71 participants (35 immediate, 36 deferred) experienced a CVD event with no difference in CVD event rates between the immediate and deferred arms (0.17 vs 0.17 per 100 person-years, respectively); these findings were consistent across the pre-2016 and post-1Jan2016 periods. There were 58 CVD events among males (33 immediate; 25 deferred) and 13 among females (2 immediate; 11 deferred). A possible benefit of immediate ART was seen in females but not males (Hazard Ratio = 0.19 [95% confidence interval: 0.04-0.86] vs 1.33 [0.79-2.24]; interaction P-value = .014), though numbers of events were low.

Conclusions: Early versus deferred ART initiation was not associated with reduced CVD events. The potential benefit associated with immediate ART in female participants warrants further evaluation.

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艾滋病毒感染者早期与延迟抗逆转录病毒治疗开始和长期心血管疾病结局：START研究

背景：目前尚不清楚延迟抗逆转录病毒治疗（ART）是否会恶化艾滋病毒感染者（PHIV）的心血管疾病结局。这项研究比较了随机接受即时和延迟ART治疗的PHIV患者的心血管事件发生率。方法：ART-naïve CD4+计数为bb0 500细胞/µL的成人PHIV随机分为立即和延迟ART起始组。估计了主要复合心血管疾病结局（心肌梗死、需要血运重建的冠状动脉疾病、中风和心血管相关死亡）的事件发生率：(i) 2016年前（设计的治疗组）；（ii） 2016年1月1日后（ART使用类似交叉臂）；（iii）整个研究随访期。根据基线特征进行亚组分析。结果：在4684名参与者中（中位年龄36岁，27%为女性，30%为黑人），32%为吸烟者，17% BMI≥30 kg/m2。合并症包括高血压（19%）、血脂异常（8%）、糖尿病（3%）；0.8%有心血管疾病病史。延迟治疗组开始抗逆转录病毒治疗的中位时间为2.5年（四分位数范围[IQR] 1.6-3.5年），立即治疗组为7天（IQR 2-17天）。在整个研究随访期间（中位随访9.3年），71名参与者（35名即时组，36名延迟组）经历了CVD事件，即时组和延迟组的CVD事件发生率无差异（分别为0.17 vs 0.17 / 100人-年）；这些发现在2016年前和2016年1月1日后都是一致的。男性58例（33例即刻发生，25例延期发生），女性13例（2例即刻发生，11例延期发生）。立即抗逆转录病毒治疗可能对女性有益处，但对男性没有（风险比= 0.19[95%可信区间：0.04-0.86]vs 1.33[0.79-2.24]；相互作用p值= 0.014），尽管事件数量较低。结论：早期与延迟ART起始与减少CVD事件无关。女性参与者立即接受抗逆转录病毒治疗的潜在益处值得进一步评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Open Forum Infectious Diseases Medicine-Neurology (clinical)

CiteScore

6.70

自引率

4.80%

发文量

630

审稿时长

9 weeks

期刊介绍： Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.