Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide Significantly Worsens the Lipid Profile in a Real-World Setting.

Tenofovir disoproxil fumarate (TDF) has increasingly been replaced by tenofovir alafenamide (TAF) because of reduced kidney and bone toxicity with TAF. This switch has, however, caused worsening of lipid concentrations in clinical trials, but data from any real-world setting are scarce. The objective of this study was to characterize the effect of TDF to TAF switch on plasma lipid concentrations in a real-world clinic population. This is a retrospective study comparing lipid concentrations and other laboratory parameters between the last visit on TDF and the first visit after at least a 2-month exposure to TAF. A total of 490 HIV-positive subjects were included in the study. The median (interquartile range) increase was 23.2 (0-38.7) mg/dL in total cholesterol (p < 0.001) and 15.5 (0-30.9) mg/dL in low-density lipoprotein (LDL) cholesterol (p < 0.001). The ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol increased by 0.2 (-0.2 to 0.6), p < 0.001. The proportion of patients having optimal LDL cholesterol concentration by National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) decreased from 30.8% to 17.8% and proportion having dyslipidemia or severe dyslipidemia increased from 30.2% to 50.3% after the switch. Demographic characteristics, antiretroviral agents, or comedication did not affect the changes in lipid concentrations. Plasma creatinine decreased by 0.03 (-0.09 to 0.03) mg/dL (p < 0.001) and estimated glomerular filtration rate increased by 0.5 (-2.3 to 3.2) mL/min (p = 0.009). Switching from TDF to TAF caused a statistically significant worsening of the lipid profile that may have clinical relevance. The benefit of the lipid-lowering effect of TDF should be considered in selected patients with low risk for kidney and bone toxicity.