Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients.

Objectives: To assess the impact of switching to tenofovirdisoproxil fumarate+ emtricitabineon lipid parameters. Methods: HIV-infected patients with plasma viral load 4.1 mmol/L were randomized to switch the nucleoside reverse transcriptase inhibitor(NRTI) backbone to fixed-dose combination tenofovirdisoproxil fumarate+ emtricitabineor to maintain the baseline antiretroviral regimen (the control group). The study has been registered with ClinicalTrials.gov under the identifer NCT00323492. Results: Ninety-one patients were included in the intent-to-treat (ITT) analysis with triglycerides 2.4 mmol/L and LDL-cholesterol 4.0 mmol/L (median values). At week 12, the median changes from baseline of triglycerides were -0.5 mmol/L (-25%; n=46) and -0.1 mmol/L (-6%; n=45) in the tenofovirdisoproxil fumarate+ emtricitabineand control groups, respectively, indicating a difference of -0.4 mmol/L (P=0.034) [95% confidence interval (CI): -0.9 to -0.0]. Similarly for LDL-cholesterol, changes of -0.4 mmol/L (-9%) and -0.1 mmol/L (-1%) were observed in the tenofovirdisoproxil fumarate+ emtricitabineand control groups, respectively, indicating a difference of -0.4 mmol/L (P=0.031) [95% CI: -0.7 to -0.0]. The proportion of patients with LDL-cholesterol >4.1 mmol/L decreased from 48% at baseline to 26% at week 12 in the tenofovirdisoproxil fumarate+ emtricitabinegroup versus no change in the control group. No virological failure was observed during the study. Conclusions: Switching to tenofovirdisoproxil fumarate+ emtricitabinein dyslipidaemic HIV-infected patients improves triglycerides and LDL-cholesterol.