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Bone Mineral Density Changes in People with HIV Who had Immediate Switch Versus Deferred Switch from Tenofovir Disoproxil Fumarate-Based Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Multicenter, Open-Label, Randomized Clinical Trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: INTRODUCTION: Tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy regimens remain one of the first-line treatments in many countries. We assessed the changes of bone mineral density (BMD) in people with HIV (PWH) who had early switch from TDF-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). METHODS: This 48-week, multicenter, randomized, open-label clinical trial recruited adult PWH on TDF-based regimens with virological suppression for at least 24 weeks. Participants were randomly assigned (1:1) to immediately switch to B/F/TAF (immediate switch group) or switch after 24 weeks (deferred switch group). The primary endpoint was the median percentage change [interquartile range (IQR)] in BMD from baseline to week 48. RESULTS: Between December 17, 2021 and February 21, 2023, 150 PWH were randomly assigned to immediate switch group (n = 75) or deferred switch group (n = 75). At week 48, no significant difference in BMD changes of the spine was observed at week 48 [3.30% (IQR 1.19, 5.47) vs. 2.84% (0.51, 5.00); P = 0.199]. The increase in hip BMD was greater in the immediate switch group than deferred switch group [median percentage change, 2.05% (0.20, 4.12) vs. 0.88% (- 0.52, 3.15); P = 0.035]. Viral suppression at week 48 was noted in 71 (94.6%) participants assigned to the immediate switch group and in 67 (89.3%) assigned to the deferred switch group. Similar rates and severity of adverse events were observed in both groups, with no serious adverse events reported. CONCLUSIONS: While both immediate and deferred switch from TDF-based regimens to B/F/TAF maintained virological suppression, early switch resulted in better improvement of BMD in the hip joint. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov (NCT05122754).

Source: Infectious Diseases and Therapy

DOI: 10.1007/s40121-025-01262-8