STEAL Switch NRTIs to Tenofovir DFEmtricitabine or AbacavirLamivudine STEAL Study Design Source Martin A et al Clin Infect Dis 2009491591 1601 Study Design STEAL Background ID: 1043239
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1. Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-LamivudineSTEAL
2. Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-LamivudineSTEAL: Study DesignSource: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.Study Design: STEALBackground: 96-week, randomized, open-label, non-inferiority trial comparing a switch of the NRTI backbone to either TDF-FTC or ABC-3TC in virologically suppressed personsInclusion Criteria:- Adults with HIV infection- Receiving stable cART including 2 NRTI’s plus a boosted PI or NNRTI- HIV RNA <50 copies/mL for >12 weeks- Estimated GFR >70 mL/min- HLA-B*5701 negative or already receiving and tolerating ABC- Not receiving TDF for hepatitis B coinfection treatmentSwitch NRTI’s to TDF-FTC(n = 178)Switch NRTI’s to ABC-3TC(n = 179)STEAL = Simplification to Tenofovir DF-Emtricitabine or Abacavir-Lamivudine
3. Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-LamivudineSTEAL: ResultsWeek 96 Virologic Failures (Intention-to-Treat Analysis)Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.P = 0.62
4. Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-LamivudineSTEAL: ResultsWeek 96: Change in Plasma Lipids from Baseline Source: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.P < 0.01P = 0.006P = 0.004P = 0.08
5. Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-LamivudineSTEAL: ResultsSource: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.STEAL: Results, Adverse Events (AE’s)TDF-FTC+ [PI or NNRTI]ABC-3TC+ [PI or NNRTI]P ValueSerious non-AIDS events4140.018Cardiovascular events180.048Lipid-related event119400.003Bone-related event227140.0321 New lipid-lowering therapy, or significant increase in LDL or decrease in HDL2 Incident osteopenia or osteoporosis or new antiresorptive therapy
6. Switch NRTIs to Tenofovir DF-Emtricitabine or Abacavir-LamivudineSTEAL: ConclusionsSource: Martin A, et al. Clin Infect Dis. 2009;49:1591-1601.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.”
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