比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺用于初治一线治疗的HIV-1感染黑人及西班牙裔/拉丁裔成人的疗效和安全性：两项III期研究的5年随访
Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in Black and Hispanic/Latine adults with HIV-1 initiating first-line therapy: 5-year follow-up from two phase III studies.
作者信息
Martorell C, Ramgopal M, Hagins D, Osiyemi O, Arribas J R, Berhe M, Yazdanpanah Y, Orkin C, Santiago L, Rosero C, Unger N, Liu H, Rogers R, Hindman J T, Wurapa A
机构信息
The Research Institute, Springfield, Massachusetts, USA.
Midway Immunology and Research Center, Fort Pierce, Florida, USA.
出版信息
HIV Med. 2025 Jun;26(6):858-869. doi: 10.1111/hiv.70018. Epub 2025 Mar 21.
INTRODUCTION
Black and Hispanic/Latine people are disproportionately affected by HIV-1 and may have a greater risk of comorbidities than non-Black and non-Hispanic/Latine people with HIV. However, they have historically been underrepresented in HIV clinical studies. We aimed to assess the efficacy and safety of first-line antiretroviral therapy with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) over 5 years in Black and Hispanic/Latine people with HIV.
METHODS
We present two post hoc pooled analyses of participants who received B/F/TAF up to week 240 in studies 1489 (NCT02607930) and 1490 (NCT02607956). Outcomes were compared between self-identified Black and non-Black participants and between Hispanic/Latine and non-Hispanic/Latine participants, including baseline characteristics, proportion with HIV-1 RNA <50 copies/mL, change in CD4 cell count, adherence, changes in metabolic parameters, and treatment-emergent adverse events.
RESULTS
Overall, 211 Black, 421 non-Black, 155 Hispanic/Latine, and 477 non-Hispanic/Latine participants received B/F/TAF up to week 240. At baseline, median ages were 30-34 years, and 84%-91% were male at birth. At week 240, high proportions of Black (97%), non-Black (99%), Hispanic/Latine (100%), and non-Hispanic/Latine (98%) participants had HIV-1 RNA <50 copies/mL. Black people with HIV were more likely than non-Black people with HIV to have low (<85%) adherence (11% vs. 5%; p = 0.0074). Changes in CD4 count, metabolic and renal parameters, and treatment-emergent hypertension and diabetes were generally similar between Black and non-Black and Hispanic/Latine and non-Hispanic/Latine participants. A smaller proportion of Black than non-Black people with HIV experienced study drug-related treatment-emergent adverse events (20% vs. 32%; p = 0.0026).
CONCLUSIONS
These results demonstrate the durability and long-term safety of B/F/TAF in Black and Hispanic/Latine people with HIV.
引言
黑人以及西班牙裔/拉丁裔人群受人类免疫缺陷病毒1型（HIV-1）的影响尤为严重，与非黑人及非西班牙裔/拉丁裔HIV感染者相比，他们患合并症的风险可能更高。然而，在HIV临床研究中，他们的代表性一直不足。我们旨在评估比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）一线抗逆转录病毒疗法在HIV感染的黑人和西班牙裔/拉丁裔人群中5年的疗效和安全性。
方法
我们对在1489（NCT02607930）和1490（NCT02607956）研究中接受B/F/TAF治疗至第240周的参与者进行了两项事后汇总分析。比较了自我认定的黑人与非黑人参与者之间以及西班牙裔/拉丁裔与非西班牙裔/拉丁裔参与者之间的结果，包括基线特征、HIV-1 RNA<50拷贝/mL的比例、CD4细胞计数变化、依从性、代谢参数变化以及治疗中出现的不良事件。
结果
总体而言，211名黑人、421名非黑人、155名西班牙裔/拉丁裔和477名非西班牙裔/拉丁裔参与者接受B/F/TAF治疗至第240周。基线时，中位年龄为30 - 34岁，84% - 91%为出生时男性。在第240周时，高比例的黑人（97%）、非黑人（99%）、西班牙裔/拉丁裔（100%）和非西班牙裔/拉丁裔（98%）参与者的HIV-1 RNA<50拷贝/mL。与非黑人HIV感染者相比，黑人HIV感染者依从性低（<85%）的可能性更高（11%对5%；p = 0.0074）。黑人与非黑人以及西班牙裔/拉丁裔与非西班牙裔/拉丁裔参与者之间的CD4细胞计数、代谢和肾脏参数变化以及治疗中出现的高血压和糖尿病情况总体相似。与非黑人HIV感染者相比，经历与研究药物相关的治疗中出现不良事件的黑人比例较小（20%对32%；p = 0.0026）。
结论
这些结果证明了B/F/TAF在HIV感染的黑人和西班牙裔/拉丁裔人群中的持久性和长期安全性。
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