Donga Prina, Emond Bruno, Rossi Carmine, Bookhart Brahim K, Lee Johnnie, Caron-Lapointe Gabrielle, Wei Fangzhou, Lafeuille Marie-Hélène
Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Analysis Group, Inc, Montréal, QC, Canada.
Clinicoecon Outcomes Res. 2023 Jul 24;15:579-591. doi: 10.2147/CEOR.S413800. eCollection 2023.
Integrase strand transfer inhibitor-based regimens (eg, containing dolutegravir [DTG]) are associated with weight/body mass index (BMI) increases among people living with HIV-1 (PLWH). Assessing antiretroviral therapy (ART)-related weight/BMI changes is challenging, as PLWH may experience return-to-health weight gain as a result of viral suppression. This retrospective, longitudinal real-world study compared weight/BMI outcomes among overweight/obese (BMI ≥25 kg/m; thus excluding return-to-health weight/BMI changes), treatment-naïve PLWH who initiated darunavir (DRV)/cobicistat (c)/emtricitabine (FTC)/tenofovir alafenamide (TAF) or DTG + FTC/TAF.
Treatment-naïve PLWH with BMI ≥25 kg/m who initiated DRV/c/FTC/TAF or DTG + FTC/TAF (index date) had ≥12 months of baseline observation and ≥1 weight/BMI measurement in baseline and post-index periods in the Symphony Health IDV database (07/17/2017-12/31/2021) were included. Inverse probability of treatment weighting (IPTW) was used to balance differences in baseline characteristics between cohorts. On-treatment time-to-weight/BMI increases ≥5% were compared between cohorts using weighted adjusted Cox models.
Post-IPTW, 76 overweight/obese DRV/c/FTC/TAF-treated (mean age = 51.2 years, 30.7% female, 35.6% Black, mean baseline BMI = 33.2 kg/m) and 88 overweight/obese DTG + FTC/TAF-treated PLWH (mean age = 51.5 years, 31.4% female, 31.4% Black, mean baseline BMI = 32.7 kg/m) were included. The median [interquartile range] time from ART initiation to weight/BMI increase ≥5% was shorter for the DTG + FTC/TAF cohort (21.8 [9.9, 32.3] months) than the DRV/c/FTC/TAF cohort (median and interquartile times not reached; Kaplan-Meier rate at 21.8 months = 20.8%). Over the entire follow-up, overweight/obese PLWH initiating DTG + FTC/TAF had a more than twofold greater risk of experiencing weight/BMI increase ≥5% compared to those initiating DRV/c/FTC/TAF (hazard ratio [95% confidence interval]=2.43 [1.02; 7.04]; p = 0.036).
Overweight/obese PLWH who initiated DTG + FTC/TAF had significantly greater risk of weight/BMI increase ≥5% compared to similar PLWH who initiated DRV/c/FTC/TAF and had shorter time-to-weight/BMI increase ≥5%, suggesting a need for additional monitoring to assess the risk of weight gain-related cardiometabolic disease.
基于整合酶链转移抑制剂的治疗方案（例如，含有多替拉韦 [DTG]）与人类免疫缺陷病毒1型感染者（PLWH）的体重/体重指数（BMI）增加有关。评估抗逆转录病毒疗法（ART）相关的体重/BMI变化具有挑战性，因为PLWH可能因病毒抑制而经历恢复健康的体重增加。这项回顾性纵向真实世界研究比较了超重/肥胖（BMI≥25kg/m²；因此排除恢复健康的体重/BMI变化）、初治的PLWH在开始使用达芦那韦（DRV）/考比司他（c）/恩曲他滨（FTC）/替诺福韦艾拉酚胺（TAF）或DTG+FTC/TAF后的体重/BMI结果。
在Symphony Health IDV数据库（2017年7月17日至2021年12月31日）中，纳入了BMI≥25kg/m²、开始使用DRV/c/FTC/TAF或DTG+FTC/TAF（索引日期）的初治PLWH，他们在基线期有≥12个月的观察期，并且在基线期和索引期后有≥1次体重/BMI测量。使用治疗权重的逆概率（IPTW）来平衡队列之间基线特征的差异。使用加权调整的Cox模型比较队列之间体重/BMI增加≥5%的治疗时间。
IPTW后，纳入了76名接受DRV/c/FTC/TAF治疗的超重/肥胖PLWH（平均年龄 = 51.2岁，30.7%为女性，35.6%为黑人，平均基线BMI = 33.2kg/m²）和88名接受DTG+FTC/TAF治疗的超重/肥胖PLWH（平均年龄 = 51.5岁，31.4%为女性，31.4%为黑人，平均基线BMI = 32.7kg/m²）。DTG+FTC/TAF队列从开始ART到体重/BMI增加≥5%的中位[四分位间距]时间（21.8[9.9, 32.3]个月）比DRV/c/FTC/TAF队列短（未达到中位和四分位时间；21.8个月时的Kaplan-Meier率 = 20.8%）。在整个随访期间，开始使用DTG+FTC/TAF的超重/肥胖PLWH体重/BMI增加≥5%的风险是开始使用DRV/c/FTC/TAF的PLWH的两倍多（风险比[95%置信区间]=2.43[1.02；7.04]；p = 0.036）。
与开始使用DRV/c/FTC/TAF的类似PLWH相比，开始使用DTG+FTC/TAF的超重/肥胖PLWH体重/BMI增加≥5%的风险显著更高，且体重/BMI增加≥5%的时间更短，这表明需要额外监测以评估体重增加相关的心血管代谢疾病风险。
