在美国,对使用含替诺福韦艾拉酚胺、富马酸替诺福韦二吡呋酯或两者都不含的抗逆转录病毒方案的HIV-1患者体重增加和体重指数升高情况的真实世界分析。
Real-World Analysis of Weight Gain and Body Mass Index Increase Among Patients with HIV-1 Using Antiretroviral Regimen Containing Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Neither in the United States.
作者信息
Emond Bruno, Rossi Carmine, Rogers Rachel, Lefebvre Patrick, Lafeuille Marie-Hélène, Donga Prina
机构信息
Analysis Group, Inc., Montréal, Québec, Canada.
Janssen Scientific Affairs, LLC., Titusville, New Jersey, USA.
出版信息
J Health Econ Outcomes Res. 2022 Feb 14;9(1):39-49. doi: 10.36469/jheor.2022.31825. eCollection 2022.
While some studies among patients with HIV-1 suggest that antiretroviral therapy (ART) regimens containing tenofovir alafenamide (TAF) may be associated with greater weight gain than those not containing TAF, no studies have assessed the relationship between TAF doses and weight change. To evaluate weight-related outcomes among patients with HIV-1 in the United States initiating ART containing different nucleoside reverse transcriptase inhibitors and doses. A retrospective longitudinal study was conducted using Decision Resources Group's electronic medical records (July 17, 2017-March 1, 2020). Adult patients with HIV-1 initiating ART (index date) containing TAF 25 mg, TAF 10 mg, tenofovir disoproxil fumarate (TDF), or neither TAF nor TDF on or after July 17, 2018, were included. Changes in weight and body mass index (BMI) from pre-index to 3, 6, 9, and 12 months post-index were compared between cohorts using mean differences obtained from ordinary least squares models adjusted for baseline characteristics. Time-to-weight and BMI increase ≥5% were compared using Cox models adjusted for baseline characteristics. Among 1652 eligible patients (TAF 25 mg, n=710; TAF 10 mg, n=303; TDF, n=219; non-TAF/TDF, n=420), the majority (83.2%-99.5%) initiated an integrase strand transfer inhibitor, except for the TDF cohort (45.2%). Patients initiating TAF 25 mg had greater weight or BMI increase across all time points compared with patients initiating TAF 10 mg, TDF, or non-TAF/TDF regimens (mean differences in weight or BMI changes between cohorts at 12 months post-index ranged from 0.78 kg [1.72 lb] to 1.34 kg [2.95 lb] and from 0.77 kg/m2 to 1.95 kg/m2, respectively), although findings were not statistically significant for all comparisons. Compared with TAF 25 mg, time-to-weight and BMI increase ≥5% in the other treatment cohorts were longer (hazard ratios ranged from 0.77 to 0.94), although findings were generally not statistically significant. Among a population of patients predominantly initiating integrase strand transfer inhibitors, increases in weight and BMI post-ART initiation were common and appeared to be higher and occur more rapidly among patients receiving TAF 25 mg compared with lower TAF doses or other nucleosides. When considering long-term health consequences, weight gain is an important factor to consider when selecting an ART regimen.
虽然一些针对HIV-1患者的研究表明,与不含替诺福韦艾拉酚胺(TAF)的抗逆转录病毒疗法(ART)方案相比,含TAF的方案可能与更多的体重增加有关,但尚无研究评估TAF剂量与体重变化之间的关系。为了评估美国开始接受含不同核苷类逆转录酶抑制剂及剂量的ART治疗的HIV-1患者的体重相关结局。使用决策资源集团的电子病历进行了一项回顾性纵向研究(2017年7月17日至2020年3月1日)。纳入了2018年7月17日及以后开始接受含25mg TAF、10mg TAF、富马酸替诺福韦二吡呋酯(TDF)或既不含TAF也不含TDF的ART治疗(索引日期)的成年HIV-1患者。使用根据基线特征调整的普通最小二乘法模型得到的均值差异,比较各队列从索引前到索引后3、6、9和12个月的体重和体重指数(BMI)变化。使用根据基线特征调整的Cox模型比较体重和BMI增加≥5%的时间。在1652名符合条件的患者中(25mg TAF组,n=710;10mg TAF组,n=303;TDF组,n=219;非TAF/TDF组,n=420),除TDF队列(45.2%)外,大多数(83.2%-99.5%)患者开始使用整合酶链转移抑制剂。与开始使用10mg TAF、TDF或非TAF/TDF方案的患者相比,开始使用25mg TAF的患者在所有时间点的体重或BMI增加更多(索引后12个月各队列体重或BMI变化的均值差异分别为0.78kg[1.72磅]至1.34kg[2.95磅]和0.77kg/m²至1.95kg/m²),尽管并非所有比较结果都具有统计学意义。与25mg TAF相比,其他治疗队列中体重和BMI增加≥5%的时间更长(风险比范围为0.77至0.94),尽管结果通常无统计学意义。在主要开始使用整合酶链转移抑制剂的患者群体中,ART开始后体重和BMI增加很常见,与较低剂量TAF或其他核苷类药物相比,接受25mg TAF的患者体重增加似乎更多且更快。在考虑长期健康后果时,选择ART方案时体重增加是一个重要的考虑因素。