Presentation Abstract

Session: 099-Antiretroviral Therapy of HIV-1 Infection
Sunday, Sep 18, 2011, 11:15 AM - 1:15 PM
Presentation Title: H2-786 - SWIFT Study: Switching from Lamivudine/Abacavir (3TC/ABC) to Emtricitabine/ Tenofovir DF (FTC/TDF) Based Regimen Improves Lipid Parameters While Maintaining Virologic Suppression
Location: Exhibit Hall F1
Poster Board Number: 273
Presentation Number: H2-786
Pres. Time: Sunday, Sep 18, 2011, 11:15 AM - 1:15 PM
Category: H2
Keywords: FTC/TDF; 3TC/ABC; switch
Author(s): R. Campo, MD - Professor of Clinical Medicine1, E. Dejesus, MD, FACP - Medical Director 2, H. Khanlou, MD - Chief of Medicine 3, H. Wang, MS Statistics - Sr Biostatistician 4, L. Dau, PharmD - Sr Med Proj Mgr 4, T. Fralich, MD - Director Med Affairs 4, J. Flaherty, PharmD - Director Clinical Research 4;
1Univ of Miami Sch of Med, Miami, FL, 2Orlando Immunology Ctr, Orlando, FL, 3AIDS Healthcare Fndn., Los Angeles, CA, 4Gilead Sci., Foster City, CA.
Financial Disclosures:  R. Campo,
Gilead Sciences Role(s): Consultant, Grant Investigator, Research Relationship, Scientific Advisor (Review Panel or Advisory Committee), Received: Research Grant, Research Support, Speaker Honorarium.
Merck Role(s): Consultant, Grant Investigator, Research Relationship, Scientific Advisor (Review Panel or Advisory Committee), Received: Research Grant, Research Support, Speaker Honorarium.
Pfizer Role(s): Consultant, Grant Investigator, Research Relationship, Received: Research Grant, Research Support.
Abbott Role(s): Consultant, Scientific Advisor (Review Panel or Advisory Committee), Received: Speaker Honorarium.
Tibotec Role(s): Consultant, Scientific Advisor (Review Panel or Advisory Committee), Received: Speaker Honorarium.
Merck Role(s): Shareholder (excluding diversitied mutual funds), Wife is a shareholder of Merck and receives stock grants., Received: Other Financial Benefit.
E. Dejesus,
BMS Role(s): Consultant, Research Relationship, Speaker's Bureau, Received: Research Support, Speaker Honorarium.
Gilead Sciences Role(s): Consultant, Research Relationship, Speaker's Bureau, Received: Research Support, Speaker Honorarium.
GSK Role(s): Consultant, Research Relationship, Speaker's Bureau, Received: Research Support, Speaker Honorarium.
Merck Role(s): Consultant, Research Relationship, Speaker's Bureau, Received: Research Support, Speaker Honorarium.
Tibotec Role(s): Consultant, Research Relationship, Speaker's Bureau, Received: Research Support, Speaker Honorarium.
Abbott Role(s): Research Relationship, Received: Research Support.
Achillion Role(s): Research Relationship, Received: Research Support.
Avexa Role(s): Research Relationship, Received: Research Support.
Boehringer Ingelheim Role(s): Research Relationship, Received: Research Support.
Hoffman LaRoche Role(s): Research Relationship, Received: Research Support.
H. Khanlou,
Gilead Sciences Role(s): Speaker's Bureau, Received: Research Grant.
Tibotec Role(s): Speaker's Bureau, Received: Research Grant.
Salix Role(s): Speaker's Bureau, Received: Research Grant.
H. Wang,
Gilead Sciences Role(s): Employee, Received: Salary.
L. Dau,
Gilead Sciences Role(s): Employee, Received: Salary.
T. Fralich,
Gilead Sciences Role(s): Employee, Received: Salary.
J. Flaherty,
Gilead Sciences Role(s): Employee, Received: Salary.
Abstract: Background: Fixed-dose FTC/TDF and 3TC/ABC have been directly compared in treatment naïve and experienced subjects. Data on the potential advantages of switching from 3TC/ABC to FTC/TDF are limited. Methods: Prospective, open-label, multicenter, randomized 48 week study to evaluate the safety and efficacy of a strategy to switch subjects from 3TC/ABC to FTC/TDF. Subjects receiving 3TC/ABC with HIV RNA < 200c/mL ≥ 3 months were randomized (1:1) to either continue 3TC/ABC +PI/r or switch to FTC/TDF +PI/r. Subjects were stratified by PI/r (LPV/r vs. other) and co-morbidities. Primary endpoint was time to loss of virologic response (TLOVR, premature discontinuation, or ARV modification = failure). Results: 311 subjects were treated (FTC/TDF 155, 3TC/ABC 156). Baseline characteristics for all subjects were 85% males, 28% African Americans, median age 46 years, median CD4 532 cells/mm3, and 72% had comorbidities and were similar between the groups. Early discontinuation rates were similar (11%) in both groups. Through Week 48, 86.5% on FTC/TDF and 83.3% on 3TC/ABC maintained HIV RNA <200 copies/mL by TLOVR, with treatment difference (95% CI) of 3.1% (-5% to 11%) indicating non-inferiority of FTC/TDF to 3TC/ABC (Δ=12%). Higher rate of virologic failure was seen with 3TC/ABC vs FTC/TDF (8% vs 2%; p=0.033). Adverse events were similar between groups; 1 subject in each group discontinued for renal event. At Week 48, FTC/TDF compared to 3TC/ABC showed greater declines in median fasting LDL (-7 vs 2 mg/dL; p=0.007), total cholesterol (-21 vs -3 mg/dL; p<0.001), and triglycerides (-16 vs. -9 mg/dL; p=0.08). At Week 48, median decrease from baseline in estimated GFR (Cockcroft-Gault) was -8 and -5 mL/min (p=0.012) for FTC/TDF and 3TC/ABC. Conclusions: In virologically suppressed subjects receiving 3TC/ABC, switching 3TC/ABC to FTC/TDF can improve lipid profile while reducing the risk of virologic failure.




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