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

G. Fätkenheuer, C. Duvivier, A. Rieger, J. Durant, D. Rey, W. Schmidt, A. Hill, Y. van Delft, S. Marks, N. Vetter, R. Greil, C. Pedersen, M. Storgaard, P. Morlat, C. Katlama, L. Cotte, C. Duvvier, S. Esser, C. Stellbrink, M. StollC. Stephan, A. Stoehr, J. Rockstroh, D. Banhegyi, L. Itzchak, E. Shahar, S. Maayan, D. Turner, A. Lazzarin, A. Antinori, G. Carosi, L. Minoli, G. di Perri, G. Filice, M. Andreoni, D. Duiculescu, S. Rugina, S. Erscoiu, A. Streinu, A. Pronin, V. Pokrovsky, B. Gruzdev, A. Yakovlev, E. Voronin, B. Clotet, J. Gatell, J. Arribas, D. Podzamczer, P. Domingo, C. Miralles Alvarez, J. Hernandez Quero, H. Furrer, J. Feher, M. Johnson, J. Fox, M. Nelson, M. Fisher, C. Orkin

Research output: Contribution to journalArticle

Abstract

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 (n = 79) or 600 mg of efavirenz once daily (n = 78) 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 74-722) and a median HIV RNA of 4.8 log 10 copies/mL (range 3.5-6.6). 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, P = 0.004), low-density lipoprotein (LDL) (+0.35 mmol/L, P = 0.005), total cholesterol (+0.61 mmol/L, P <0.0001) and triglycerides (+0.33 mmol/L, P = 0.03) 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, P = 0.005) 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.

Original languageEnglish
Article numberdkr533
Pages (from-to)685-690
Number of pages6
JournalJournal of Antimicrobial Chemotherapy
Volume67
Issue number3
DOIs
Publication statusPublished - Mar 2012

Keywords

  • Antiretroviral treatment
  • Cholesterol
  • Lipid elevations
  • Non-nucleoside reverse transcriptase inhibitors
  • Nucleoside analogues

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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