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Background <p>Despite numerous small-scale studies, the correlation between tenofovir alafenamide fumarate (TAF) and hyperlipidemia remains still limited. This study aims to evaluate the safety of TAF regarding hyperlipidemia and cardiovascular diseases using a nationwide cohort.</p> Methods <p>We conducted a retrospective analysis of claims data from the Health Insurance Review and Assessment Service, comparing incidence rates of hyperlipidemia and major adverse cardiovascular events (MACE) using 1:1 propensity score matching between TAF and tenofovir disoproxil fumarate (TDF) users.</p> Results <p>The incidence of hyperlipidemia among TAF users was 21.38 per 1000 person-years, compared to 10.04 among TDF users. The incidence rate ratio (IRR) was 2.13 (95% confidence interval [CI] 1.92–2.36), indicating a significantly higher incidence in TAF users compared to TDF users (<i>p</i> &lt; 0.001). After adjusting for other factors, Cox regression analysis showed that TAF was significantly associated with hyperlipidemia compared to TDF (hazard ratio [HR] 1.99, 95% CI 1.79–2.20, <i>p</i> &lt; 0.001). There was no significant difference in the incidence of MACE between TDF and TAF users (2.19 per 1,000 person-years for TDF and 2.25 per 1,000 person-years for TAF, IRR 1.02, 95% CI 0.79–1.33, <i>p</i> = 0.853), with Cox regression analysis showing no disparity between the groups (HR 1.03, 95% CI 0.78–1.36, <i>p</i> = 0.829).</p> Conclusions <p>TAF is associated with a higher incidence of hyperlipidemia than TDF. While the incidence of MACE in the TAF group has not shown a significant increase compared to the TDF group, further investigation into long-term outcomes is warranted. Lipid monitoring in TAF and TDF patients is essential for managing risks and reducing cardiovascular complications.</p>

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Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis

  • 期刊论文

  • 发表日期：

    2025年3月8日

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  • Jae-Young Kim,
  • Hyuk Kim,
  • Jeong-Ju Yoo,
  • Sang Gyune Kim,
  • Young-Seok Kim

摘要

Background

Despite numerous small-scale studies, the correlation between tenofovir alafenamide fumarate (TAF) and hyperlipidemia remains still limited. This study aims to evaluate the safety of TAF regarding hyperlipidemia and cardiovascular diseases using a nationwide cohort.

Methods

We conducted a retrospective analysis of claims data from the Health Insurance Review and Assessment Service, comparing incidence rates of hyperlipidemia and major adverse cardiovascular events (MACE) using 1:1 propensity score matching between TAF and tenofovir disoproxil fumarate (TDF) users.

Results

The incidence of hyperlipidemia among TAF users was 21.38 per 1000 person-years, compared to 10.04 among TDF users. The incidence rate ratio (IRR) was 2.13 (95% confidence interval [CI] 1.92–2.36), indicating a significantly higher incidence in TAF users compared to TDF users (p < 0.001). After adjusting for other factors, Cox regression analysis showed that TAF was significantly associated with hyperlipidemia compared to TDF (hazard ratio [HR] 1.99, 95% CI 1.79–2.20, p < 0.001). There was no significant difference in the incidence of MACE between TDF and TAF users (2.19 per 1,000 person-years for TDF and 2.25 per 1,000 person-years for TAF, IRR 1.02, 95% CI 0.79–1.33, p = 0.853), with Cox regression analysis showing no disparity between the groups (HR 1.03, 95% CI 0.78–1.36, p = 0.829).

Conclusions

TAF is associated with a higher incidence of hyperlipidemia than TDF. While the incidence of MACE in the TAF group has not shown a significant increase compared to the TDF group, further investigation into long-term outcomes is warranted. Lipid monitoring in TAF and TDF patients is essential for managing risks and reducing cardiovascular complications.