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

31 Citations (Scopus)

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

Fingerprint

efavirenz
etravirine
Lipids
Tenofovir
Nucleosides
Therapeutics
Cholesterol
HIV
RNA

Keywords

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

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Fätkenheuer, G., Duvivier, C., Rieger, A., Durant, J., Rey, D., Schmidt, W., ... Orkin, C. (2012). Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. Journal of Antimicrobial Chemotherapy, 67(3), 685-690. [dkr533]. https://doi.org/10.1093/jac/dkr533

Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. / Fätkenheuer, G.; Duvivier, C.; Rieger, A.; Durant, J.; Rey, D.; Schmidt, W.; Hill, A.; van Delft, Y.; Marks, S.; Vetter, N.; Greil, R.; Pedersen, C.; Storgaard, M.; Morlat, P.; Katlama, C.; Cotte, L.; Duvvier, C.; Esser, S.; Stellbrink, C.; Stoll, M.; Stephan, C.; Stoehr, A.; Rockstroh, J.; Banhegyi, D.; Itzchak, L.; Shahar, E.; Maayan, S.; Turner, D.; Lazzarin, A.; Antinori, A.; Carosi, G.; Minoli, L.; di Perri, G.; Filice, G.; Andreoni, M.; Duiculescu, D.; Rugina, S.; Erscoiu, S.; Streinu, A.; Pronin, A.; Pokrovsky, V.; Gruzdev, B.; Yakovlev, A.; Voronin, E.; Clotet, B.; Gatell, J.; Arribas, J.; Podzamczer, D.; Domingo, P.; Alvarez, C. Miralles; Quero, J. Hernandez; Furrer, H.; Feher, J.; Johnson, M.; Fox, J.; Nelson, M.; Fisher, M.; Orkin, C.

In: Journal of Antimicrobial Chemotherapy, Vol. 67, No. 3, dkr533, 03.2012, p. 685-690.

Research output: Contribution to journalArticle

Fätkenheuer, G, Duvivier, C, Rieger, A, Durant, J, Rey, D, Schmidt, W, Hill, A, van Delft, Y, Marks, S, Vetter, N, Greil, R, Pedersen, C, Storgaard, M, Morlat, P, Katlama, C, Cotte, L, Duvvier, C, Esser, S, Stellbrink, C, Stoll, M, Stephan, C, Stoehr, A, Rockstroh, J, Banhegyi, D, Itzchak, L, Shahar, E, Maayan, S, Turner, D, Lazzarin, A, Antinori, A, Carosi, G, Minoli, L, di Perri, G, Filice, G, Andreoni, M, Duiculescu, D, Rugina, S, Erscoiu, S, Streinu, A, Pronin, A, Pokrovsky, V, Gruzdev, B, Yakovlev, A, Voronin, E, Clotet, B, Gatell, J, Arribas, J, Podzamczer, D, Domingo, P, Alvarez, CM, Quero, JH, Furrer, H, Feher, J, Johnson, M, Fox, J, Nelson, M, Fisher, M & Orkin, C 2012, 'Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial', Journal of Antimicrobial Chemotherapy, vol. 67, no. 3, dkr533, pp. 685-690. https://doi.org/10.1093/jac/dkr533
Fätkenheuer, G. ; Duvivier, C. ; Rieger, A. ; Durant, J. ; Rey, D. ; Schmidt, W. ; Hill, A. ; van Delft, Y. ; Marks, S. ; Vetter, N. ; Greil, R. ; Pedersen, C. ; Storgaard, M. ; Morlat, P. ; Katlama, C. ; Cotte, L. ; Duvvier, C. ; Esser, S. ; Stellbrink, C. ; Stoll, M. ; Stephan, C. ; Stoehr, A. ; Rockstroh, J. ; Banhegyi, D. ; Itzchak, L. ; Shahar, E. ; Maayan, S. ; Turner, D. ; Lazzarin, A. ; Antinori, A. ; Carosi, G. ; Minoli, L. ; di Perri, G. ; Filice, G. ; Andreoni, M. ; Duiculescu, D. ; Rugina, S. ; Erscoiu, S. ; Streinu, A. ; Pronin, A. ; Pokrovsky, V. ; Gruzdev, B. ; Yakovlev, A. ; Voronin, E. ; Clotet, B. ; Gatell, J. ; Arribas, J. ; Podzamczer, D. ; Domingo, P. ; Alvarez, C. Miralles ; Quero, J. Hernandez ; Furrer, H. ; Feher, J. ; Johnson, M. ; Fox, J. ; Nelson, M. ; Fisher, M. ; Orkin, C. / Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. In: Journal of Antimicrobial Chemotherapy. 2012 ; Vol. 67, No. 3. pp. 685-690.
@article{df63dc77151d481ea2e883e8c414512f,
title = "Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial",
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.",
keywords = "Antiretroviral treatment, Cholesterol, Lipid elevations, Non-nucleoside reverse transcriptase inhibitors, Nucleoside analogues",
author = "G. F{\"a}tkenheuer and C. Duvivier and A. Rieger and J. Durant and D. Rey and W. Schmidt and A. Hill and {van Delft}, Y. and S. Marks and N. Vetter and R. Greil and C. Pedersen and M. Storgaard and P. Morlat and C. Katlama and L. Cotte and C. Duvvier and S. Esser and C. Stellbrink and M. Stoll and C. Stephan and A. Stoehr and J. Rockstroh and D. Banhegyi and L. Itzchak and E. Shahar and S. Maayan and D. Turner and A. Lazzarin and A. Antinori and G. Carosi and L. Minoli and {di Perri}, G. and G. Filice and M. Andreoni and D. Duiculescu and S. Rugina and S. Erscoiu and A. Streinu and A. Pronin and V. Pokrovsky and B. Gruzdev and A. Yakovlev and E. Voronin and B. Clotet and J. Gatell and J. Arribas and D. Podzamczer and P. Domingo and Alvarez, {C. Miralles} and Quero, {J. Hernandez} and H. Furrer and J. Feher and M. Johnson and J. Fox and M. Nelson and M. Fisher and C. Orkin",
year = "2012",
month = "3",
doi = "10.1093/jac/dkr533",
language = "English",
volume = "67",
pages = "685--690",
journal = "Journal of Antimicrobial Chemotherapy",
issn = "0305-7453",
publisher = "Oxford University Press",
number = "3",

}

TY - JOUR

T1 - Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial

AU - Fätkenheuer, G.

AU - Duvivier, C.

AU - Rieger, A.

AU - Durant, J.

AU - Rey, D.

AU - Schmidt, W.

AU - Hill, A.

AU - van Delft, Y.

AU - Marks, S.

AU - Vetter, N.

AU - Greil, R.

AU - Pedersen, C.

AU - Storgaard, M.

AU - Morlat, P.

AU - Katlama, C.

AU - Cotte, L.

AU - Duvvier, C.

AU - Esser, S.

AU - Stellbrink, C.

AU - Stoll, M.

AU - Stephan, C.

AU - Stoehr, A.

AU - Rockstroh, J.

AU - Banhegyi, D.

AU - Itzchak, L.

AU - Shahar, E.

AU - Maayan, S.

AU - Turner, D.

AU - Lazzarin, A.

AU - Antinori, A.

AU - Carosi, G.

AU - Minoli, L.

AU - di Perri, G.

AU - Filice, G.

AU - Andreoni, M.

AU - Duiculescu, D.

AU - Rugina, S.

AU - Erscoiu, S.

AU - Streinu, A.

AU - Pronin, A.

AU - Pokrovsky, V.

AU - Gruzdev, B.

AU - Yakovlev, A.

AU - Voronin, E.

AU - Clotet, B.

AU - Gatell, J.

AU - Arribas, J.

AU - Podzamczer, D.

AU - Domingo, P.

AU - Alvarez, C. Miralles

AU - Quero, J. Hernandez

AU - Furrer, H.

AU - Feher, J.

AU - Johnson, M.

AU - Fox, J.

AU - Nelson, M.

AU - Fisher, M.

AU - Orkin, C.

PY - 2012/3

Y1 - 2012/3

N2 - 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.

AB - 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.

KW - Antiretroviral treatment

KW - Cholesterol

KW - Lipid elevations

KW - Non-nucleoside reverse transcriptase inhibitors

KW - Nucleoside analogues

UR - http://www.scopus.com/inward/record.url?scp=84863393499&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84863393499&partnerID=8YFLogxK

U2 - 10.1093/jac/dkr533

DO - 10.1093/jac/dkr533

M3 - Article

C2 - 22210755

AN - SCOPUS:84863393499

VL - 67

SP - 685

EP - 690

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

SN - 0305-7453

IS - 3

M1 - dkr533

ER -