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Introduction <p>This study aimed to evaluate the safety and the effectiveness of B/F/TAF in patients living with HIV-1 treated in real-world settings in the Republic of Korea (ROK).</p> Methods <p>This prospective, multicenter, observational study aimed to enroll all patients initiating B/F/TAF at 45 sites between July 2019 and November 2023. Safety was assessed up to 48&#xa0;weeks post-treatment initiation. HIV-1 RNA and CD4 + T-cell were recorded at baseline, and then at approximately 48&#xa0;weeks (i.e., between 36 and 64&#xa0;weeks) post-treatment initiation.</p> Results <p>Of the 2844 patients enrolled, 2761 were analyzed (mean age 44 ± 14&#xa0;years; 93.48% male; 81.53% treatment-experienced). Adverse events were reported in 37.16% of patients, adverse drug reactions (ADRs) in 5.40%, serious adverse events in 3.48%, and serious adverse drug reactions in 0.04%. No fatal ADRs were reported. Viral suppression rates (HIV-1 RNA &lt; 50 copies/mL) were 97.83% for treatment-experienced patients, 93.84% for treatment-naïve, and 97.19% overall. CD4⁺ T-cell counts increased in both groups.</p> Conclusion <p>In this large real-world cohort, B/F/TAF demonstrated a favorable safety profile and high effectiveness, consistent with prior studies. No new safety concerns were identified.</p>

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The Safety and Effectiveness of B/F/TAF for HIV-1 in a Prospective Multicenter Observational Study in the Republic of Korea

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月30日

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  • Jami Peters,
  • Sook-In Jung,
  • Lauren Liu,
  • Kimberly Suekawa-Pirrone,
  • Keith Aizen,
  • Jeong-a Lee,
  • Yeon-Jae Kim

摘要

Introduction

This study aimed to evaluate the safety and the effectiveness of B/F/TAF in patients living with HIV-1 treated in real-world settings in the Republic of Korea (ROK).

Methods

This prospective, multicenter, observational study aimed to enroll all patients initiating B/F/TAF at 45 sites between July 2019 and November 2023. Safety was assessed up to 48 weeks post-treatment initiation. HIV-1 RNA and CD4 + T-cell were recorded at baseline, and then at approximately 48 weeks (i.e., between 36 and 64 weeks) post-treatment initiation.

Results

Of the 2844 patients enrolled, 2761 were analyzed (mean age 44 ± 14 years; 93.48% male; 81.53% treatment-experienced). Adverse events were reported in 37.16% of patients, adverse drug reactions (ADRs) in 5.40%, serious adverse events in 3.48%, and serious adverse drug reactions in 0.04%. No fatal ADRs were reported. Viral suppression rates (HIV-1 RNA < 50 copies/mL) were 97.83% for treatment-experienced patients, 93.84% for treatment-naïve, and 97.19% overall. CD4⁺ T-cell counts increased in both groups.

Conclusion

In this large real-world cohort, B/F/TAF demonstrated a favorable safety profile and high effectiveness, consistent with prior studies. No new safety concerns were identified.