A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals.
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 re...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2015-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC4319732?pdf=render |
| _version_ | 1818333846823763968 |
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| author | Graeme J Moyle Chloe Orkin Martin Fisher Jyoti Dhar Jane Anderson Edmund Wilkins Jacqueline Ewan Ramin Ebrahimi Hui Wang ROCKET 1 (Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial) Study Group |
| author_facet | Graeme J Moyle Chloe Orkin Martin Fisher Jyoti Dhar Jane Anderson Edmund Wilkins Jacqueline Ewan Ramin Ebrahimi Hui Wang ROCKET 1 (Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial) Study Group |
| author_sort | Graeme J Moyle |
| collection | DOAJ |
| description | 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 6.32 mmol/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 -0.74 mmol/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 -0.86 mmol/l (p < 0.001) compared with +0.01 mmol/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 -0.73 mmol/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. TRIAL REGISTRATION:ClinicalTrials.gov NCT00615810. |
| first_indexed | 2024-12-13T13:58:08Z |
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| id | doaj.art-6db7e27da8c24cca86951f1d6432e3da |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-13T13:58:08Z |
| publishDate | 2015-01-01 |
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| spelling | doaj.art-6db7e27da8c24cca86951f1d6432e3da2022-12-21T23:42:50ZengPublic Library of Science (PLoS)PLoS ONE1932-62032015-01-01102e011629710.1371/journal.pone.0116297A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals.Graeme J MoyleChloe OrkinMartin FisherJyoti DharJane AndersonEdmund WilkinsJacqueline EwanRamin EbrahimiHui WangROCKET 1 (Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial) Study GroupBACKGROUND: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 6.32 mmol/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 -0.74 mmol/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 -0.86 mmol/l (p < 0.001) compared with +0.01 mmol/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 -0.73 mmol/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. TRIAL REGISTRATION:ClinicalTrials.gov NCT00615810.http://europepmc.org/articles/PMC4319732?pdf=render |
| spellingShingle | Graeme J Moyle Chloe Orkin Martin Fisher Jyoti Dhar Jane Anderson Edmund Wilkins Jacqueline Ewan Ramin Ebrahimi Hui Wang ROCKET 1 (Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial) Study Group A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. PLoS ONE |
| title | A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. |
| title_full | A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. |
| title_fullStr | A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. |
| title_full_unstemmed | A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. |
| title_short | A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. |
| title_sort | randomized comparative trial of continued abacavir lamivudine plus efavirenz or replacement with efavirenz emtricitabine tenofovir df in hypercholesterolemic hiv 1 infected individuals |
| url | http://europepmc.org/articles/PMC4319732?pdf=render |
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