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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 A5202 Study ASSERT Study. HEAT. HEAT Study: ABC/3TC vs TDF/FTC. Randomisation* 1 : 1 Double-blind placebo-matched. Design. W48. W96. N = 343. 694 ARV-naïve patients > 18 years

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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 A5202 Study • ASSERT Study

  2. HEAT HEAT Study: ABC/3TC vs TDF/FTC Randomisation* 1 : 1 Double-blind placebo-matched • Design W48 W96 N = 343 694 ARV-naïve patients > 18 years HIV RNA > 1,000 c/mL Any CD4 cell count No HLA-B*5701 screening N = 345 *Randomisation was stratified on HIV RNA < 100,000 c/mL or > 100,000 c/mL • Objective • Non inferiority of the 2 fixed dose NRTI combinations at W48: % HIV RNA < 50 c/mL, ITT-exposed, missing = failure [ITT-E, M = F] (lower margin of the 95% CI for the difference = - 12%, 90% power) • Primary safety endpoint: incidence of adverse events at W96 Smith KY. AIDS 2009;23:1547-56

  3. HEAT HEAT Study: ABC/3TC vs TDF/FTC Patient disposition and baseline characteristics Note: change of NRTI (to NRTI other than ABC or TDF) allowed if intolerance; change of LPV/r QD to BID allowed if gastrointestinal intolerance, or to other PI if LPV/r-limiting intolerance. LPV/r was administered as soft-gel capsules (6/d) to week 48 then as tablets (4/d) Smith KY. AIDS 2009;23:1547-56

  4. HEAT HEAT Study: ABC/3TC vs TDF/FTC Proportion of patients with HIV RNA < 50 c/mL at week 48 % ABC/3TC TDF/FTC 100 Primary efficacy endpoint 87 84 80 71 69 68 67 65 64 63 63 62 61 60 40 20 N = 343 345 343 345 343 345 188 205 155 140 0 ITT-E, M/D = F TLOVR ITT, M/D = F Observed analysis, ITT-E ITT-E, M/D = F stratified by baseline HIV RNA (c/mL) 95% CI for the difference= - 6.6; 7.4 > 100 000 < 100 000 Median CD4 increase at W96: 250/mm3 (ABC/3TC) vs 247/mm3 (TDF/FTC) ITT-E, M = F: ITT-exposed, missing/discontinuation = failure Smith KY. AIDS 2009;23:1547-56

  5. HEAT HEAT Study: ABC/3TC vs TDF/FTC Safety and tolerability (median exposure = 96 weeks) * Including suspected ABC HSR (N = 14), immune reconstitution syndrome (N = 2), hepatotoxicity (N = 1) ** Including suspected ABC HSR (N = 3), renal failure (N = 2), decreased creatinine renal clearance (N = 1) Smith KY. AIDS 2009;23:1547-56

  6. HEAT HEAT Study: ABC/3TC vs TDF/FTC Change in laboratory parameters (lipids, renal, biomarkers) Smith KY. AIDS 2009;23:1547-56

  7. HEAT Study: ABC/3TC vs TDF/FTC • Conclusions • As initial antiretroviral regimens, ABC/3TC and TDF/FTC, each in combination with LPV/r QD, have the same efficacy rate • HIV RNA responses by baseline HIV RNA strata (< or > 100,000 c/mL)were similar between groups at W48 and W96 • Rate of virologic failure was similar in both groups (14%) • CD4 response at W96 was similar in the 2 groups • Both treatments were well tolerated • More gastrointestinal intolerance with TDF/FTC • More lipid abnormalities with ABC/3TC • Of note, rate of discontinuation washigh (34% at W96) Smith KY. AIDS 2009;23:1547-56

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