Chen Yen-Wen, Hardy Helene, Pericone Christopher D, Chow Wing
Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Janssen Research & Development, LLC, Titusville, NJ, USA.
J Health Econ Outcomes Res. 2020 Jul 16;7(2):102-110. doi: 10.36469/jheor.2020.13457. eCollection 2020.
Studies have shown an increase in weight among people living with human immunodeficiency virus (PLWH) who have also initiated integrase strand transfer inhibitors (INSTI). However, limited data are available regarding comparison of these changes with other antiretroviral regimens.
To assess differences in weight gain after initiating INSTI- versus protease inhibitor (PI)-based regimens among treatment-naïve PLWH overall, and among a subpopulation of females only.
This retrospective, observational cohort study included data from the Optum deidentified Electronic Health Record (EHR) database. Adult PLWH who initiated INSTI- or PI-based regimens between March 1, 2016 and June 30, 2018 (index date was the first INSTI or PI prescription in this period) with ≥12-month baseline and follow-up periods, ≥1 weight measure during each period, and no prior antiretroviral use were included. The last weight measure between 12 months pre- and 30 days post-index was defined as baseline weight; the last measure between the months 4 and 12 of follow-up was defined as post-weight. Weight change was reported as absolute change and proportion of patients with increased weight. Cohorts were balanced using propensity score (PS) matching. Multivariable models were used to compare outcomes of interest.
After matching, 1588 patients were included (794 per cohort). At baseline, 46% were <50 years old, 26% were females, 12% had Type II diabetes and 30% had hypertension (mean baseline weight: INSTI: 83 kg (183 lb), PI: 82 kg (181 lb); = 0.3). The mean time to follow-up weight measure was 9.3 months; INSTI initiators had a 1.3 kg (2.9 lb) greater mean weight gain (95% CI: 0.5-2.0), and a higher proportion with ≥5% weight gain (30.7% vs 26.1%; [OR=1.3, 95% CI: 1.0-1.6]) than PI initiators. Differences in weight gain between regimens were larger among females; female INSTI initiators had a 2.5 kg (5.3 lb) greater mean weight gain (95% CI: 0.7-4.2) and a higher proportion with ≥5% weight gain (37.5% vs 26.4%; OR=1.7; 95% CI [1.1-2.6]) than PI initiators.
In a real-world setting, compared to PI-based regimens, INSTI-based regimens are associated with greater weight gain for treatment-naïve PLWH. This study may inform HIV treatment choice for health care providers.
研究表明，开始使用整合酶链转移抑制剂（INSTI）的人类免疫缺陷病毒感染者（PLWH）体重增加。然而，关于将这些变化与其他抗逆转录病毒治疗方案进行比较的数据有限。
评估初治PLWH总体人群以及仅女性亚组人群开始基于INSTI与基于蛋白酶抑制剂（PI）的治疗方案后体重增加的差异。
这项回顾性观察队列研究纳入了Optum去识别电子健康记录（EHR）数据库的数据。纳入2016年3月1日至2018年6月30日期间开始基于INSTI或PI治疗方案的成年PLWH（索引日期为此期间的首个INSTI或PI处方），基线期和随访期≥12个月，每期≥1次体重测量，且既往未使用过抗逆转录病毒药物。索引前12个月至索引后30天之间的最后一次体重测量定义为基线体重；随访第4至12个月之间的最后一次测量定义为随访后体重。体重变化以绝对变化和体重增加患者的比例报告。使用倾向评分（PS）匹配使队列平衡。采用多变量模型比较感兴趣的结局。
匹配后，纳入1588例患者（每组794例）。基线时，46%年龄<50岁，26%为女性，12%患有II型糖尿病，30%患有高血压（平均基线体重：INSTI组：83千克（183磅），PI组：82千克（181磅）；P=0.3）。随访体重测量的平均时间为9.3个月；与PI组起始者相比，INSTI组起始者平均体重增加更大，为1.3千克（2.9磅）（95%CI：0.5 - 2.0），体重增加≥5%的比例更高（30.7%对26.1%；[OR = 1.3，95%CI：1.0 - 1.6]）。不同治疗方案之间的体重增加差异在女性中更大；与PI组起始者相比，女性INSTI组起始者平均体重增加更大，为2.5千克（5.3磅）（95%CI：0.7 - 4.2），体重增加≥5%的比例更高（37.5%对26.4%；OR = 1.7；95%CI[1.1 - 2.6]）。
在真实世界中，与基于PI的治疗方案相比，初治PLWH使用基于INSTI的治疗方案体重增加更多。本研究可为医疗保健提供者的HIV治疗选择提供参考。
