Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial

Background: Etravirine is approved for use in treatment-experienced patients at a dose of 200 mg twice daily. Efavirenz has been associated with greater increases in serum lipids compared with other non-nucleosides in randomized trials of first-line treatment. Methods:In this double-blind, placebo-controlled trial, 157 treatment-naive patients with HIV RNA 5000 copies/mL were randomized 1:1 to either 400 mg of etravirine once daily (n79) or 600 mg of efavirenz once daily (n78) plus two nucleoside analogues (either abacavir/lamivudine, zidovudine/lamivudine or tenofovir/emtricitabine) for 48 weeks. Lipids were measured under fasting conditions at baseline and all visits to Week 48. Clinicaltrials.gov identifier: NCT00903682. Results:Overall, the patients had a median baseline CD4 count of 302 cells/mm(3) (range 74722) and a median HIV RNA of 4.8 log(10) copies/mL (range 3.56.6). Both the non-nucleosides and the nucleoside analogues used caused changes in serum lipids. In the efavirenz arm, patients showed significantly larger increases in high-density lipoprotein (HDL) (0.15 mmol/L, P0.004), low-density lipoprotein (LDL) (0.35 mmol/L, P0.005), total cholesterol (0.61 mmol/L, P0.0001) and triglycerides (0.33 mmol/L, P0.03) at Week 48 compared with the etravirine arm. Across the two arms, patients taking abacavir/lamivudine showed greater increases in total cholesterol (0.47 mmol/L, P0.005) compared with patients taking tenofovir/emtricitabine. There were fewer grade 3/4 elevations in total cholesterol, LDL and triglycerides in the etravirine arm (2 patients, 1 patient and 0 patients, respectively) versus the efavirenz arm (8 patients, 6 patients and 2 patients, respectively). Conclusions:In the SENSE trial, first-line treatment with 400 mg of etravirine once daily plus two nucleoside analogues led to fewer grade 3 or 4 lipid elevations compared with efavirenz plus two nucleoside analogues.