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

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.