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Abstract：
Background: Recent evidence suggests that integrase strand transfer inhibitors are associated with greater weight gain than protease inhibitors in patients with human immunodeficiency virus (HIV-1). Objectives: To describe demographic and clinical characteristics of insured patients with HIV-1 in the United States initiating darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/FTC/TAF) or bictegravir/FTC/TAF (BIC/FTC/TAF), assess the differences in weight and body mass index (BMI) change between cohorts up to one year after treatment initiation, and identify the predictors of weight gain associated with each treatment. Methods: The Symphony Health, IDV® database (July 17, 2017 - September 30, 2019) was used to identify treatment naïve or virologically suppressed stable switchers who initiated DRV/c/FTC/TAF or BIC/FTC/TAF (index date) on or after July 17, 2018, were ≥18 years of age on the index date, and had ≥12 months of continuous clinical activity pre-index (baseline period). To account for differences in baseline characteristics, inverse-probability of treatment weighting (IPTW) was used. Mean weight and BMI change from pre- to post-index measurements were compared between weighted cohorts at 3, 6, 9, and 12 months post-index using mean differences. Predictors of weight or BMI gain ≥5% were evaluated at last measurement, for each treatment cohort separately. Results: After IPTW, 452 and 497 patients were included in the DRV/c/FTC/TAF and BIC/FTC/TAF cohorts, respectively. Baseline characteristics were generally well-balanced (mean age=~50 years, female: ~30%), except for the type of antiretroviral therapy from which patients switched. Patients initiated on BIC/FTC/TAF experienced greater weight and BMI increases between the pre-index period and each measurement of the post-index period than patients initiated on DRV/c/FTC/TAF, although results were only statistically significant at 9 months post-index (weight: mean difference=2.50 kg, P=0.005; BMI: mean difference=0.66 kg/m2, P=0.027). A common predictor of weight or BMI gain ≥5% among patients in both cohorts was female gender (DRV/c/FTC/TAF: odds ratio [OR]=5.92, P=0.014; BIC/FTC/TAF: OR=2.00, P<0.001). Conclusion: Patients in the BIC/FTC/TAF cohort experienced greater weight and BMI increases than patients in the DRV/c/FTC/TAF cohort, with differences reaching statistical significance at 9 months post-index. Weight gain is an important factor to consider when selecting antiretroviral regimens, since it is associated with long-term health consequences. Future studies with larger sample size and longer follow-up time are warranted.
摘要：
背景：最近的证据表明，在人类免疫缺陷病毒（HIV-1）患者中，整合酶链转移抑制剂比蛋白酶抑制剂与更大的体重增加有关。目标：描述在美国开始darunavir/cobicitstat/恩曲他滨/替诺福韦艾拉酚胺（DRV/c/FTC/TAF）或bictegravir/FTC/TAF（BIC/FTC/TAF）的保险HIV-1患者的人口统计学和临床特征。在治疗开始后一年内，评估队列之间体重和体重指数（BMI）变化的差异，并确定与每种治疗相关的体重增加的预测因子。方法：交响乐健康，IDV®数据库（2017年7月17日至2019年9月30日）用于识别在2018年7月17日或之后启动DRV/c/FTC/TAF或BIC/FTC/TAF（索引日期）的初始治疗或病毒学抑制的稳定切换者，在索引日期年龄≥18岁，并且具有≥12个月的连续临床活动预指数（基线期）。为了说明基线特征的差异，使用治疗加权的逆概率(IPTW)。在指数后3、6、9和12个月，使用平均差异比较了指数测量前后的平均体重和BMI变化。在最后一次测量时评估体重或BMI增加≥5%的预测因子，分别为每个治疗队列。结果：IPTW后，452和497例患者被纳入DRV/c/FTC/TAF和BIC/FTC/TAF队列，分别。基线特征通常很平衡(平均年龄=~50岁，女性：~30%），除了抗逆转录病毒疗法的类型，从病人切换。与使用DRV/c/FTC/TAF的患者相比，使用BIC/FTC/TAF的患者在索引前阶段和索引后阶段的每次测量之间的体重和BMI增加更大，尽管结果仅在指数后9个月具有统计学意义（体重：平均差异=2.50kg，P=0.005；BMI：平均差=0.66kg/m2，P=0.027）。两个队列中的患者体重或BMI增加≥5%的常见预测因素是女性(DRV/c/FTC/TAF:比值比[OR]=5.92,P=0.014;BIC/FTC/TAF:OR=2.00,P<0.001)。结论：与DRV/c/FTC/TAF队列患者相比，BIC/FTC/TAF队列患者的体重和BMI增加更大，差异在指数后9个月达到统计学意义。体重增加是选择抗逆转录病毒疗法时要考虑的重要因素，因为它与长期健康后果有关。未来的研究需要更大的样本量和更长的随访时间。
