An observational cohort study was conducted with data from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort to investigate weight gain among virologically suppressed people with HIV (PWH) switching to regimens containing tenofovir alafenamide/emtricitabine/(TAF/FTC). Virologically suppressed, antiretroviral therapy (ART)-experienced PWH switching to TAF/FTC with darunavir/cobicistat (DRV/c), elvitegravir/cobicistat (EVG/c), dolutegravir (DTG), or bictegravir (BIC) were selected. Cox proportional hazards models were used to assess the risk of excessive weight gain (i.e., ≥5% gain within 28 weeks or ≥10% within 54 weeks), by regimen. A linear mixed effects model with random intercept and restricted cubic splines on time was used to assess continuous changes in weight. Confounding was controlled for with both inverse probability of treatment weighting and traditional covariate adjustment. Among 5,536 PWH, 18% gained ≥5% of their weight within 28 weeks, and 9% gained ≥10% within 54 weeks. There were no differences in the risk of excessive weight gain by regimen, although there was a nonstatistically significant 20% increase in the risk of gaining ≥10% within 54 weeks with all regimens compared to DRV/c. Throughout follow-up, the mean predicted weight remained fairly constant, with no notable differentiation between regimens. Expected weight gains ranged from +0.2 to +0.3 kg at 6 months and from +0.5 to +0.6 kg at 24 months. In conclusion, in this study of virologically suppressed, ART-experienced PWH switching to regimens containing TAF/FTC and DRV/c, EVG/c, DTG, or BIC, up to 18% experienced excessive levels of weight gain. However, no statistically significant difference was observed across regimens.

中文翻译：

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体重过度增加：目前在病毒学抑制的 HIV 感染者中使用抗逆转录病毒药物

使用观察性药物流行病学研究与分析 (OPERA) 队列的数据进行了一项观察性队列研究，以调查病毒学抑制的 HIV 感染者 (PWH) 转用含有替诺福韦艾拉酚胺/恩曲他滨/(TAF/FTC) 的方案后体重增加情况。选择病毒学抑制、抗逆转录病毒治疗 (ART) 经验的 PWH 转换为 TAF/FTC 与地瑞那韦/cobicistat (DRV/c)、elvitegravir/cobicistat (EVG/c)、dolutegravir (DTG) 或 bictegravir (BIC)。Cox 比例风险模型用于按方案评估体重过度增加的风险（即，28 周内增加≥5% 或 54 周内增加≥10%）。使用具有随机截距和受限三次样条的线性混合效应模型来评估体重的连续变化。通过治疗加权的逆概率和传统的协变量调整来控制混杂。在 5,536 名 PWH 中，18% 的人在 28 周内体重增加了 ≥ 5%，9% 的人在 54 周内增加了 ≥ 10%。尽管与 DRV/c 相比，所有方案在 54 周内体重增加 ≥ 10% 的风险增加了 20%，但在非统计学上显着增加了 20%，但不同方案的体重过度增加风险没有差异。在整个随访期间，平均预测体重保持相当稳定，方案之间没有显着差异。预期体重增加在 6 个月时为 +0.2 至 +0.3 公斤，在 24 个月时为 +0.5 至 +0.6 公斤。总之，在这项病毒学抑制的研究中，经历过 ART 的 PWH 转换为包含 TAF/FTC 和 DRV/c、EVG/c、DTG 或 BIC 的方案，高达 18% 的人体重增加过多。然而，在不同方案之间没有观察到统计学上的显着差异。