Background Tenofovir alafenamide (TAF) in clinical trials demonstrated less impact than tenofovir disoproxil (TDF) in affecting renal and bone parameters, whereas TDF protects from hypercholesterolaemia and hypertriglyceridaemia.
Purpose To analyse in clinical practice of human immunodeficiency virus-infected (HIV-infected), how renal function and fasting lipid parameters are modified when switching TDF to TAF. As a second aim, to evaluate effectiveness and the immunological system.
Material and methods Retrospective observational study (July 2016 to August 2018) conducted in HIV-infected patients treated for ≥6 months with a TDF regimen who switched to a TAF regimen kept >48 weeks. We considered virological success if HIV-1 RNA <35 copies/mL.
Demographic variables were registered. Follow-up variables: serum-creatinine, phosphataemia, glomerular filtration rate (GFR calculated by CKD-EPI), total cholesterol (TC), hight-density-lipoprotein (HDL), low-density-lipoprotein (LDL), triglycerides, CD4 +cell counts and HIV RNA-concentration.
Two-sided t-student test was used for comparing pre-post variables except for GFR with two-sided Wilcoxon signed-rank test. We used Pearson correlation coefficient (r) evaluating the relation with TC and HDL-LDL.
Variables were extracted from: electronic clinical records (SAP) and the pharmacy-dispensation program (Silicon). The statistical data were analysed with SPSS.
Results Forty-eight patients were included, mean age 44 years (range 21–70), 79.2% males. Most received antiretroviral treatment (ART) with emtricitabine/elvitegravir/cobicistat (44/48).
There were significant differences from baseline to 48 weeks with serum-creatinine, TC, HDL and CD4+. Serum-creatinine decreased 0.08 mg/dL with TAF (0.98±0.18 mg/dL with TDF, p=0.0001); TC, HDL and CD4 were greater with TAF; difference 19.8 mg/dL (173.4 mg/dL with TDF, p=0.0001), 8.7 mg/dL (47.6 mg/dL with TDF, p=0.0001) and 76 cells/µL (694.2 cells/µL with TDF, p=0.02) respectively. There were no significant differences with phosphataemia, LDL and TG, but all increased with TAF (difference 0.06, 8.03 and 10.77 mg/dL, concentration with TDF 3.31, 106 and 115.4 mg/dL respectively; p>0.05). There were no statistical differences with GFR (p>0.05).
Cholesterol correlated with LDL (p=0.0001; r=0.94), but not with HDL (p>0.05; r=0.03).
All patients achieved virological success, even three patients with RNA-concentration >35 copies/mL before switching.
Conclusion After 48 weeks of patients, in clinical practice, who changed to TAF on their ART, 100% of patients archived virological suppression, with reduction in serum-creatinine and improvement in the immunological system. Nevertheless, hypercholesterolaemia was observed based mainly on LDL elevation.
References and/or acknowledgements No conflict of interest.
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