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

IF 2.8 3区医学 Q2 INFECTIOUS DISEASES

HIV Medicine Pub Date : 2025-03-21 DOI:10.1111/hiv.70018

C. Martorell, M. Ramgopal, D. Hagins, O. Osiyemi, J. R. Arribas, M. Berhe, Y. Yazdanpanah, C. Orkin, L. Santiago, C. Rosero, N. Unger, H. Liu, R. Rogers, J. T. Hindman, A. Wurapa

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引用次数: 0

Abstract

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.

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bictegravir/emtricitabine/tenofovir alafenamide 对开始一线治疗的黑人和西班牙裔/拉丁裔成年 HIV-1 感染者的疗效和安全性：两项 III 期研究的 5 年随访。

黑人和西班牙裔/拉丁人感染HIV-1的比例过高，可能比非黑人和非西班牙裔/拉丁人感染HIV有更大的合并症风险。然而，他们在HIV临床研究中的代表性一直不足。我们的目的是评估比替格拉韦/恩曲他滨/替诺福韦阿拉芬胺（B/F/TAF）一线抗逆转录病毒治疗在黑人和西班牙裔/拉丁裔艾滋病毒感染者5年以上的疗效和安全性。方法：我们对研究1489 （NCT02607930）和1490 （NCT02607956）中接受B/F/TAF治疗至240周的参与者进行了两项事后汇总分析。结果比较了自我认同的黑人和非黑人参与者以及西班牙裔/拉丁裔和非西班牙裔/拉丁裔参与者之间的结果，包括基线特征，HIV-1 RNA比例结果：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/拉丁裔参与者接受了B/F/TAF，直到第240周。基线时，中位年龄为30-34岁，出生时为男性，84%-91%。在第240周，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比例很高。结论：这些结果证明了B/F/TAF在黑人和西班牙裔/拉丁裔艾滋病毒感染者中的持久性和长期安全性。

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来源期刊

HIV Medicine 医学-传染病学

CiteScore

5.10

自引率

10.00%

发文量

167

审稿时长

6-12 weeks

期刊介绍： HIV Medicine aims to provide an alternative outlet for publication of international research papers in the field of HIV Medicine, embracing clinical, pharmocological, epidemiological, ethical, preclinical and in vitro studies. In addition, the journal will commission reviews and other feature articles. It will focus on evidence-based medicine as the mainstay of successful management of HIV and AIDS. The journal is specifically aimed at researchers and clinicians with responsibility for treating HIV seropositive patients.