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Introduction <p>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).</p> Methods <p>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&#xa0;weeks (deferred switch group). The primary endpoint was the median percentage change [interquartile range (IQR)] in BMD from baseline to week 48.</p> Results <p>Between December 17, 2021 and February 21, 2023, 150 PWH were randomly assigned to immediate switch group (<i>n</i>&#xa0;=&#xa0;75) or deferred switch group (<i>n</i>&#xa0;=&#xa0;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); <i>P</i>&#xa0;=&#xa0;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); <i>P</i>&#xa0;=&#xa0;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.</p> Conclusions <p>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.</p> Clinical Trials Registration <p>ClinicalTrials.gov (NCT05122754).</p>

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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

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  • 发表日期：

    2025年11月21日

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  • Yueming Shao,
  • Xinping Yang,
  • Jianhua Yu,
  • Xicheng Wang,
  • Jiangrong Wang,
  • Mei Liu,
  • Zongxing Yang,
  • Jie Han,
  • Renfang Zhang,
  • Li Liu,
  • Yinzhong Shen,
  • Meiyan Sun,
  • Luling Wu,
  • Zhihang Zheng,
  • Yang Tang,
  • Junyang Yang,
  • Zhenyan Wang,
  • Tangkai Qi,
  • Shuibao Xu,
  • Jingna Xun,
  • Jianjun Sun,
  • Wei Song,
  • Jun Chen

摘要

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).