Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial
Por:
Fatkenheuer, G, Duvivier, C, Rieger, A, Durant, J, Rey, D, Schmidt, W, Hill, A, van Delft, Y, Marks, S, Domingo P., SENSE Study Team
Publicada:
1 mar 2012
Resumen:
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.
Filiaciones:
Fatkenheuer, G:
Univ Hosp Cologne, Dept Internal Med 1, Cologne, Germany
Duvivier, C:
Hop Necker Enfants Malad, AP HP, Dept Infect Dis, Ctr Infectiol Necker Pasteur, Paris, France
Rieger, A:
Univ Clin, Vienna, Austria
Durant, J:
Hop Archeti, Nice, France
Rey, D:
Hop Univ, Strasbourg, France
Hill, A:
Univ Liverpool, Pharmacol Res Labs, Liverpool L69 3BX, Merseyside, England
van Delft, Y:
Janssen, Tilburg, Netherlands
Marks, S:
Janssen, Tilburg, Netherlands
Domingo P.:
Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Sant Quintí 77-79, 08041 Barcelona, Spain
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