title: A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00615810.
authors: Chelsea and Westminster Hospital, London, SW10 9NH, United Kingdom.
authors: Graeme J
authors: GJ
authors: Moyle
authors: St Bartholomew's and Royal London Hospitals, London, United Kingdom.
authors: Chloe
authors: C
authors: Orkin
authors: Brighton and Sussex University Hospitals, Brighton, BN2 5BE, United Kingdom.
authors: Martin
authors: M
authors: Fisher
authors: Leicester Royal Infirmary, Leicester, United Kingdom.
authors: Jyoti
authors: J
authors: Dhar
authors: Homerton University Hospital, London, United Kingdom.
authors: Jane
authors: J
authors: Anderson
authors: North Manchester General, Manchester, United Kingdom.
authors: Edmund
authors: E
authors: Wilkins
authors: Gilead Sciences Ltd., Cambridge, United Kingdom.
authors: Jacqueline
authors: J
authors: Ewan
authors: Gilead Sciences Inc, Foster City, California, United States of America.
authors: Ramin
authors: R
authors: Ebrahimi
authors: Gilead Sciences Inc, Foster City, California, United States of America.
authors: Hui
authors: H
authors: Wang
mesh_terms: D000328:Adult; D000480:Alkynes; D048588:Benzoxazines / Q000008:administration & dosage* / Q000009:adverse effects; D002784:Cholesterol / Q000097:blood; D003521:Cyclopropanes; D015224:Dideoxynucleosides / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D000068679:Emtricitabine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000068698:Tenofovir / Q000008:administration & dosage* / Q000009:adverse effects; D000099227:Abacavir
chemical_list: D000480:Alkynes; D048588:Benzoxazines; D002784:Cholesterol; D003521:Cyclopropanes; D015224:Dideoxynucleosides; D004338:Drug Combinations; D000068679:Emtricitabine; D019259:Lamivudine; D000068698:Tenofovir; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir; C098320:efavirenz