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在美国,接受单片制剂达芦那韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺或比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺治疗的 HIV-1 感染者中体重指数增加和体重增加的情况。

Body mass index increase and weight gain among people living with HIV-1 initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide in the United States.

机构信息

Analysis Group, Inc, Montréal, Canada.

Janssen Scientific Affairs, LLC, Titusville, NJ, USA.

出版信息

Curr Med Res Opin. 2022 Feb;38(2):287-298. doi: 10.1080/03007995.2021.2007006. Epub 2021 Dec 7.

Abstract

OBJECTIVE

This study evaluated body mass index (BMI) and weight changes in people living with human immunodeficiency virus (HIV-1; PLWH) initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/FTC/TAF) or bictegravir/FTC/TAF (BIC/FTC/TAF).

METHODS

Electronic medical record (EMR) data for treatment-naïve or virologically suppressed adults with HIV-1 who initiated treatment with DRV/c/FTC/TAF or BIC/FTC/TAF (index date) were obtained from Decision Resources Group's EMRs (17 July 2017-1 March 2020). Inverse probability of treatment weighting was used to account for differences in baseline characteristics between the two cohorts. BMI and weight changes from pre-index to 3, 6, 9 and 12 months following the index date were compared using weighted mean differences (MDs). The time until an increase in BMI or weight ≥5% or ≥10% was compared using weighted hazard ratios (HRs).

RESULTS

The weighted DRV/c/FTC/TAF and BIC/FTC/TAF cohorts comprised 1116 and 1134 PLWH, respectively (mean age = ∼49 years, females: ∼28%). Larger increases in BMI and weight from pre-index to each post-index time point were observed in PLWH initiating BIC/FTC/TAF vs DRV/c/FTC/TAF (12 months: MD in BMI = 1.23 kg/m,  < .001; MD in weight = 2.84 kg [6.26 lbs],  = .008). PLWH receiving BIC/FTC/TAF were significantly more likely to experience weight gain ≥5% (HR = 1.76,  = .004) and ≥10% (HR = 2.01,  = .020), and BMI increase ≥5% (HR = 1.77,  = .004) and ≥10% (HR = 1.76,  = .044) than those receiving DRV/c/FTC/TAF.

CONCLUSIONS

BIC/FTC/TAF was associated with greater BMI and weight increases compared to DRV/c/FTC/TAF. Weight gain and its sequelae may add to the clinical burden of PLWH and should be considered among other factors when selecting antiretroviral single-tablet regimens.

摘要

目的

本研究评估了接受达芦那韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺(DRV/c/FTC/TAF)或比克替拉韦/恩曲他滨/TAF(BIC/FTC/TAF)单一片剂治疗的人类免疫缺陷病毒(HIV-1;PLWH)患者的体重指数(BMI)和体重变化。

方法

从 Decision Resources Group 的电子病历(EMR)中获取了治疗初治或病毒学抑制的 HIV-1 成人在 2017 年 7 月 17 日至 2020 年 3 月 1 日期间开始接受 DRV/c/FTC/TAF 或 BIC/FTC/TAF 治疗(索引日期)的电子病历数据。采用逆概率治疗加权法来校正两组间基线特征的差异。使用加权均数差值(MDs)比较从基线到索引日期后 3、6、9 和 12 个月的 BMI 和体重变化。使用加权风险比(HRs)比较 BMI 或体重增加≥5%或≥10%的时间。

结果

接受 DRV/c/FTC/TAF 和 BIC/FTC/TAF 治疗的 PLWH 的加权 DRV/c/FTC/TAF 和 BIC/FTC/TAF 队列分别包含 1116 和 1134 名 PLWH(平均年龄约为 49 岁,女性约为 28%)。与接受 DRV/c/FTC/TAF 治疗的患者相比,接受 BIC/FTC/TAF 治疗的 PLWH 从基线到每个随访时间点的 BMI 和体重均有更大的增加(12 个月:BMI 的 MD=1.23kg/m,  < .001;体重的 MD=2.84kg[6.26 磅],  = .008)。接受 BIC/FTC/TAF 治疗的 PLWH 体重增加≥5%(HR=1.76,  = .004)和≥10%(HR=2.01,  = .020)以及 BMI 增加≥5%(HR=1.77,  = .004)和≥10%(HR=1.76,  = .044)的可能性明显高于接受 DRV/c/FTC/TAF 治疗的患者。

结论

与 DRV/c/FTC/TAF 相比,BIC/FTC/TAF 与更大的 BMI 和体重增加相关。体重增加及其后果可能会增加 PLWH 的临床负担,在选择抗逆转录病毒单片治疗方案时,应将其作为其他因素之一进行考虑。

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