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.
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.
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.
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