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A Randomized Comparative Trial of Continued Abacavir/Lamivudine plus Efavirenz or Replacement with Efavirenz/Emtricitabine/Tenofovir DF in Hypercholesterolemic HIV-1 Infected Individuals

Lookup NU author(s): Dr Edmund Ong

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2015 Moyle et al. Background: Drug choice and metabolic changes with antiretroviral therapy contribute to cardiovascular risk in persons with HIV-1 infection. Methods: A randomized, 12 week, open-label, comparative study of the impact on lipids of continuation of abacavir/lamivudine (ABC/3TC) plus efavirenz (EFV) or replacement with the single tablet regimen of EFV/emtricitabine/tenofovir DF (EFV/FTC/TDF) in hypercholesterolaemic subjects on successful antiretroviral therapy, with a 12-week extension with all subjects on EFV/FTC/TDF. Results: 157 subjects received study drug, 79 switched to EFV/FTC/TDF and 78 subjects continued ABC/3TC+EFV. At Week 12, 73 subjects on ABC/3TC+EFV switched to EFV/FTC/TDF. The switch was well tolerated and no subject experienced viral rebound. Median baseline fasting total cholesterol was 6.32mmol/L. 12 weeks following switch, the difference in the means (LSM) between treatment groups (EFV/FTC/TDF minus ABC/3TC+EFV) in total cholesterol change from baseline was -0.74mmol/l (95% CI -1.00, -0.47, p < 0.001). The median change from baseline in total cholesterol following switch in the EFV/FTC/TDF arm was -0.86mmol/l (p < 0.001) compared with +0.01mmol/l (p = 0.45) in the continuation arm at Week 12. Significant (p < 0.001) differences between treatment groups following switch were seen for all lipid fractions from baseline to Week 12: LDL cholesterol (-0.47 mmol/L [-0.70, -0.25]), HDL cholesterol (-0.15 mmol/L [-0.21, -0.08]), triglycerides (-0.43 mmol/L [-0.75, -0.11]), and non HDL cholesterol (-0.56 mmol/L [-0.80, -0.31]). In the extension phase, similar declines in total cholesterol were observed with a median change from Week 12 to Week 24 of -0.73mmol/L (p < 0.001). Conclusions: Switching from ABC/3TC+EFV to EFV/FTC/TDF in persons with hypercholesterolemia maintains virological control and significantly improves key lipid parameters.


Publication metadata

Author(s): Moyle GJ, Orkin C, Fisher M, Dhar J, Anderson J, Wilkins E, Ewan J, Ebrahimi R, Wang H, Ainsworth J, Waters A, Anderson J, Morumba L, Brook G, Chikohora M, Hay P, Adebiyi A, Cockerill M, Ndoro M, Johnson M, Carroll A, Turner F, Moyle G, Fletcher C, Osorio J, Orkin C, Hand J, Desouza C, Fisher M, Perry N, Maher T, Bray A, De Burgh Thomas A, Bunting M, Jones L, White D, Groves J, Ross J, Brown L, Hood K, Dhar J, Johnson S, Morgan E, Hewart R, Ong E, Wilkins E, Stockwell E, Robertson A, Leen C, Morris S, Ellis L, Maw R, McKernan S, Herath DC, Ewan J, Hui Wang M, Ebrahimi R

Publication type: Article

Publication status: Published

Journal: PLoS ONE

Year: 2015

Volume: 10

Issue: 2

Online publication date: 06/02/2015

Acceptance date: 03/12/2014

Date deposited: 21/04/2017

ISSN (electronic): 1932-6203

Publisher: Public Library of Science

URL: http://doi.org/10.1371/journal.pone.0116297

DOI: 10.1371/journal.pone.0116297


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