Switching from Tenofovir Disoproxil to Tenofovir Alafenamide Fumarate: Impact on Cardiovascular Risk and Lipid Profile in People Living with HIV, an Observational Study

Abstract
In the era of combination antiretroviral therapy (ART), people living with HIV (PLHIV) still face an increased risk of cardiovascular disease (CVD). Tenofovir alafenamide fumarate (TAF) is superior to its precursor tenofovir disoproxil fumarate (TDF) regarding bone and renal toxicity, but there are concerns about a negative effect on lipid profile. This observational, single-center study investigates the effects on lipid profile and cardiovascular (CVD) risk of the switch from TDF to TAF, in combination with FTC/EVG/c, in patients with no exposure to other antiretrovirals. Routine laboratory measurements, somatometric characteristics and smoking status were analyzed for the assessment of CVD risk changes, using D:A:D and ATP III scores pre- and post-switch. A total of 62 patients with a mean age of 32.9 years were included in this study. 61 (98.4%) were males, 38 (61.3%) late presenters and 39 (62.9%) active smokers. A year after the switch, there was a significant increase in total cholesterol (178±38 to 194±40 mg/dL, p<0.001), HDL (45±12 to 48±13 mg/dL, p=0.001), LDL (117±32 to 137±36 mg/dL, p<0.001). Mean increase of the 10-year D:A:D score was 1.13% (95% CI 1.05-1.22, p=0,002). Changes were more prominent in non-smokers. Body mass index and average weight showed an upward trend. Switching from TDF to TAF caused significant changes in lipid profile at 14 months of follow-up, in young, otherwise healthy PLHIV. CVD risk, as measured by D:A:D, showed a statistically significant increase, but more data are needed to determine clinical significance. These results point towards a patient-centered approach when selecting an ART regimen.

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