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SWIFT Study: Switching From Lamivudine

2. 1. DHHS Guidelines, January 10, 2011, pp 51-522. Arribas, JR, ACTG 5202, JAIDS, 20083. Post FA, ASSERT, JAIDS, 2010 4. Mallal, S, HLA-B*5702, NEJM, 2008. Background . 5. D:A:D Study Group, Lancet, 20086. Saxs, 5202, NEJM, 20097. Martinez E, et al. BICOMBO, IAS 20078. Moyle G, et al. ROCKET I, HIV10 2010.

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SWIFT Study: Switching From Lamivudine

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    1. 1 SWIFT Study: Switching From Lamivudine/Abacavir (3TC/ABC) to Emtricitabine/Tenofovir DF (FTC/TDF) R Campo1, E DeJesus2, H Khanlou3, H Wang4, K White4, L Dau4, J Flaherty4, and T Fralich4 1Univ of Miami Sch of Med, Miami, FL, USA; 2Orlando Immunology Ctr, Orlando, FL, USA; 3AIDS Healthcare Foundation, Los Angeles, CA, USA; 4Gilead Sciences, Inc., Foster City, CA, USA

    3. SWIFT Study Design

    4. 4

    5. 5 Baseline Characteristics

    6. Subject Disposition through Week 48 Other reasons for discontinued study prematurely by FTC/TDF; 3TC/ABC Subject non-compliance 0; 0 Study discontinued by sponsor 0; 0Other reasons for discontinued study prematurely by FTC/TDF; 3TC/ABC Subject non-compliance 0; 0 Study discontinued by sponsor 0; 0

    7. 7 Primary Endpoint: TLOVR Responders with HIV-1 RNA <200 c/mL through Week 48

    8. *VF is estimated by Kaplan Meier product limit method and log-Rank test is used for detecting treatment differences through Week 48 Virologic Failure* (HIV-1 RNA ? 200 c/mL) through Week 48

    9. Adverse Events (AE) Summary

    10. eGFR through 48 Weeks

    11. 11 Fasting Lipids Change from Baseline Values at Week 48

    12. 12 Conclusions Through 48 weeks, switching to FTC/TDF was non-inferior to remaining on 3TC/ABC Significantly fewer subjects who switched to FTC/TDF experienced virologic failure compared to those who remained on 3TC/ABC through Week 48 Switching to FTC/TDF resulted in significant improvement in fasting LDL and TC Declines in eGFR of unclear clinical significance were seen in both arms and were higher in the FTC/TDF arm Switching to FTC/TDF was safe and well tolerated with similar AEs observed between arms

    13. Acknowledgements All of the subjects All investigators who participated in the SWIFT study Thank you to the study team for their dedication David Piontkowsky, JD, MD Ramin Ebrahimi, MS Todd Fralich, MD Maggie Wang, MS John Flaherty, PharmD Janet Ecker, BSN, MBA Lauren Dau, PharmD Naz Barlow, MS Kirsten White, PhD Betsy Leung, BS

    14. Back-up

    15. Forthcoming analysis to be presented at future conferences in 2011 Analysis of secondary endpoints Proportion of subjects with HIV-1 RNA < 50 copies/mL KM analysis proportion with VFs Responses by stratified by: Protease inhibitor used Baseline comorbidities CV/Framingham Lipid analysis based NCEP thresholds and lipid lowering agents Resistance in subject with detectable viremia

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