| Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. | |
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MedLine Citation:
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PMID: 22210755 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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G Fätkenheuer; C Duvivier; A Rieger; J Durant; D Rey; W Schmidt; A Hill; Y van Delft; S Marks; |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-12-29 |
Journal Detail:
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Title: The Journal of antimicrobial chemotherapy Volume: - ISSN: 1460-2091 ISO Abbreviation: - Publication Date: 2011 Dec |
Date Detail:
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Created Date: 2012-1-2 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7513617 Medline TA: J Antimicrob Chemother Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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First Department of Internal Medicine, University Hospital of Cologne, Cologne, Germany. |
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| Investigator | |
Investigator/Affiliation:
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A Rieger / ; N Vetter / ; R Greil / ; C Pedersen / ; M Storgaard / ; P Morlat / ; C Katlama / ; J Durant / ; L Cotte / ; C Duvvier / ; D Rey / ; S Esser / ; C Stellbrink / ; W Schmidt / ; M Stoll / ; C Stephan / ; G Fatkenheuer / ; 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 / |
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