Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine STEAL
Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine STEAL: Study Design Study Design: STEAL • Background : 96-week, randomized, open-label, non-inferiority trial comparing a switch of the NRTI backbone to either TDF-FTC or ABC-3TC in virologically Switch NRTI’s to TDF-FTC suppressed persons (n = 178) • Inclusion Criteria: - Adults with HIV infection - Receiving stable cART including 2 NRTI’s plus a boosted PI or NNRTI Switch NRTI’s to ABC-3TC - HIV RNA <50 copies/mL for >12 weeks (n = 179) - Estimated GFR >70 mL/min - HLA-B*5701 negative or already receiving and tolerating ABC - Not receiving TDF for hepatitis B coinfection treatment STEAL = S implification to T enofovir DF- E mtricitabine or A bacavir- L amivudine Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.
Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine STEAL: Results Week 96 Virologic Failures (Intention-to-Treat Analysis) TDF-FTC + [PI or NNRTI] ABC-3TC + [PI or NNRTI] 20 (HIV RNA >200 copies/mL) # with Virologic Failure 15 P = 0.62 10 10 7 5 0 Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.
Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine STEAL: Results Week 96: Change in Plasma Lipids from Baseline TDF-FTC + [PI or NNRTI] ABC-3TC + [PI or NNRTI] Change in Mean Value (mmol/L) 0.75 P < 0.01 P = 0.006 P = 0.004 P = 0.08 0.50 0.4 0.2 0.2 0.25 0.0 0.0 0.00 -0.1 -0.1 -0.25 -0.2 -0.50 Total Cholesterol LDL HDL Triglycerides Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.
Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine STEAL: Results STEAL: Results, Adverse Events (AE’s) TDF-FTC ABC-3TC P Value + [PI or NNRTI] + [PI or NNRTI] Serious non-AIDS events 4 14 0.018 Cardiovascular events 1 8 0.048 Lipid-related event 1 19 40 0.003 Bone-related event 2 27 14 0.032 1 New lipid-lowering therapy, or significant increase in LDL or decrease in HDL 2 Incident osteopenia or osteoporosis or new antiresorptive therapy Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.
Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine STEAL: Conclusions Conclusion : “In this population, TDF-FTC and ABC-3TC had similar virological efficacy, but ABC-3TC was associated with more serious non- AIDS events, particularly cardiovascular events.” Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center. The content in this slide set does not represent the official views of the U.S. Department of Health and Human Services, Health Resources & Services Administration.
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