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

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초록

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.

키워드

Insurance claims dataTenofovir disoproxil fumarate (TDF)Tenofovir alafenamide fumarate (TAF)Drug utilizationChronic hepatitis BCardiovascular outcomesPropensity score matchingDyslipidemia risk factorsLong-term antiviral therapyReal-world evidenceCHRONIC HEPATITIS-BDISOPROXIL FUMARATEDOUBLE-BLINDPHASE-3MULTICENTERINFECTIONCD36
제목
Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis
저자
Kim, Jae-YoungKim, HyukYoo, Jeong-JuKim, Sang GyuneKim, Young-Seok
DOI
10.1007/s12072-025-10809-3
발행일
2025-08
유형
Article
저널명
Hepatology International
19
4
페이지
959 ~ 967