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Comparison of NRTI combinations

Comparison of NRTI combinations. CBV versus TDF + FTC Study 934 ABC/3TC versus TDF/FTC HEAT Study ACTG 5202 Study ASSERT Study . ASSERT Study: ABC/3TC vs TDF/FTC. Design. Randomisation* 1 : 1 Open-label. W48. W96. N = 192. > 18 years ARV-naïve (no previous

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Comparison of NRTI combinations

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  1. Comparison of NRTI combinations • CBV versus TDF + FTC • Study 934 • ABC/3TC versus TDF/FTC • HEAT Study • ACTG 5202 Study • ASSERT Study

  2. ASSERT Study: ABC/3TC vs TDF/FTC • Design Randomisation* 1 : 1 Open-label W48 W96 N = 192 > 18 years ARV-naïve (no previous therapy with NNRTI and < 14 days of other ARV) HIV RNA > 1,000 c/mL Any CD4 cell count HLA-B*5701 negative N = 193 *Randomisation was stratified by screening GFR (< or > 90 mL/min/1.73m2), black race, body mass index (< or > 25 kg/m2) • Endpoints • Primary: change in GFR (MDRD) at W48 (90% power to detect a 10 mL/minute difference between arms) • Secondary: change in GFR (Cockroft-Gault), renal biomarkers, safety, virologic efficacy and immunologic response Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72 ASSERT

  3. ASSERT Study: ABC/3TC vs TDF/FTC Baseline characteristics and patient disposition * Includes 12 cases of suspected ABC HSR Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72 ASSERT

  4. Primary endpoint Adjusted mean change from baseline in eGFR (MDRD) (mL/min/1.73 m2), ITT-exposed: ABC/3TC = + 0.22 vs TDF/FTC = + 1.18 [95% CI for difference: -1.45; 3.35 (p = 0.44) No difference between treatment arms using the Cockroft-Gault formula or in Per Protocol ASSERT Study: ABC/3TC vs TDF/FTC Outcome at week 48 ABC/3TC TDF/FTC HIV RNA < 50 c/mL % 71 75 Virologic failure and resistance 59 50 25 * Less than 1 log10 c/mL decrease in HIV RNA at W4 or confirmed HIV RNA > 400 c/mL, having previously been < 400 c/mL at or after W4, or > 400 c/mL at or after W24 ITT, TLOVR 95% CI for the difference = 2.2; 21.1 Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72 ASSERT

  5. ASSERT Study: ABC/3TC vs TDF/FTC Safety at W48 Drug-related grade 2-4 adverse events: 29% in ABC/3TC group vs 20% in TDF/FTC No subjects met the protocol-defined decline in renal function or proximal renal tubule dysfunction criteria Some markers of renal tubular dysfunction were elevated with TDF/FTC Urinary excretion of retinol-binding protein and b-2 microglobulin increased significantly more in the TDF/FTC arm (+50%; +24%) compared with the ABC/3TC arm (no change; -47%) (P < 0.0001) Increases from baseline in median total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol were greater in the ABC/3TC arm Conclusion No difference in primary outcome (GFR) at W48 between ABC/3TC and TDF/FTC ABC/3TC was virologically inferior to TDF/FTC Protocol-defined virologic failure occurred in 3% (ABC/3TC) vs 1% (TDF/FTC) There were more discontinuations in ABC/3TC group Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72 ASSERT

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