REPRIEVE 试验中抗逆转录病毒治疗的应用模式和免疫特征。
Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.
机构信息
Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
出版信息
J Infect Dis. 2020 Jul 9;222(Suppl 1):S8-S19. doi: 10.1093/infdis/jiaa259.
BACKGROUND
Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS
The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS
A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS
There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION
NCT02344290.
背景
抗逆转录病毒疗法（ART）的使用模式和免疫相关性在全球范围内存在差异，目前的趋势尚不清楚。
方法
REPRIEVE 试验（预防 HIV 血管事件的随机试验）招募了年龄在 40-75 岁之间、正在接受 ART 治疗且心血管疾病风险较低或中度的艾滋病毒（HIV）感染者。根据全球疾病负担（GBD）超级区域对 ART 使用情况进行了总结，并采用调整后的线性和逻辑回归分析来检查与免疫参数和关键人口统计学因素的关联。
结果
共纳入 7770 名参与者，中位年龄为 50 岁（四分位距，45-55 岁）；31%为女性，43%为黑种人或非裔美国人，15%为亚洲人，56%的人体质量指数（BMI）＞25（体重以千克为单位，除以身高的平方米），49%为现吸烟者或既往吸烟者。中位 CD4 T 细胞计数为 620/µL（四分位距，447-826/µL），中位 ART 治疗持续时间为 9.5 年（5.3-14.8）年。最常见的 ART 方案是核苷（酸）逆转录酶抑制剂（NRTI）加非核苷逆转录酶抑制剂（43%）、NRTI 加整合酶链转移抑制剂（25%）和 NRTI 加蛋白酶抑制剂（19%）。入组时的 ART 方案因 GBD 区域而异，在试验入组期间有所变化。在调整后的分析中，入组时的 CD4 细胞计数和 CD4/CD8 比值与 GBD 区域、性别、入组方案、ART 治疗持续时间和最低 CD4 细胞计数有关；CD4 和 CD8 细胞计数也与 BMI 和吸烟状况有关。
结论
不同地理区域和不同时期的 ART 使用存在显著差异，这可能反映了特定药物的当地可获得性、治疗指南的变化以及医务人员和患者的偏好。对 CD4 细胞计数和 CD4/CD8 比值的分析可能为了解 HIV 感染者的免疫相关性和结局提供有价值的信息。
临床试验注册
NCT02344290。
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