Use of tenofovir disoproxil fumarate (TDF) has been associated with lower lipid levels in people living with HIV (PLWH). With the recent introduction of tenofovir alafenamide (TAF), the real-world impact on lipids of switch from TDF to TAF has not been extensively studied.
Adult PLWH prescribed TDF for ≥4 weeks who switched to TAF with ≥1 lipid measure on TDF ≤6 months prior to switch and ≥1 lipid measure ≥7 days after switch to TAF were identified in the OPERA® database (main population). Pre- and post-switch lipid levels were compared: total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TG). NCEP ATPIII cut-offs defined lipid levels (mg/dL) as normal (TC <200; LDL <100; HDL ≥60; TG <150), borderline abnormal (TC ≥200 to <240; LDL ≥100 to <130; HDL ≥40 to <60; TG ≥150 to 200), dyslipidemia (TC ≥240 to <280; LDL ≥130 to <160; HDL <40; TG ≥200 to <500) or severe/very severe dyslipidemia (TC ≥280; LDL ≥160; HDL: NA; TG ≥500). Stratification by boosting agent use pre- and post-switch was performed. A sensitivity analysis included PLWH with TDF to TAF switch and no change in other ART components. Data are presented as percent changes (95% CI) and pre/post comparison of lipid categories (Pearson’s Chi-square test).
In the main population, 6,423 PLWH switched from TDF to TAF (84% male, 33% African American, 29% Hispanic, 43% aged ≥50 years, 91% HIV RNA <200 copies/mL at switch). After switch, lipids increased on average by TC=7.9% (95% CI: 7.4, 8.3), LDL=11.1% (9.2, 12.9), HDL=7.1% (6.2, 8.0) and TG=23.8% (22.0, 25.5). In the sensitivity analysis (n=4,305), lipids increased on average by TC=9.0% (8.5, 9.6), LDL=12.2% (9.6, 14.9), HDL=8.1% (6.9, 9.2) and TG=25.8% (23.7, 28.0). After switch to TAF, the proportion of individuals with abnormal TC, LDL and TG increased and with abnormal HDL decreased in both the main (Fig 1A) and sensitivity analyses (Fig 1B). Similar patterns were observed in percent change and pre/post lipid categories after stratification of the main population by boosting agent use.
In this large, diverse population of PLWH in the US, switching from TDF to TAF was associated with development of less favorable lipid profiles. These differences persisted in analyses regardless of boosting agent use and in those whose only ART change was TDF to TAF, suggesting the changes arose as a direct result of switch from TDF to TAF.