Comparison of NNRTI vs PI/r
Mexican Study comparing EFV vs LPV/r in combination with ZDV/3TC for ARV-naïve HIV patients. EFV was found virologically superior to LPV/r due to a higher rate of virologic failure and discontinuations due to adverse events in the LPV/r group.
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Comparison of NNRTI vs PI/r EFV vs LPV/r vs EFV + LPV/r A5142 Mexican Study NVP vs ATV/r ARTEN EFV vs ATV/r A5202
Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Design Randomisation* 1 : 1 Open-label W48 N = 95 EFV 600 mg QD + ZDV/3TC BID * > 18 years ARV-na ve HIV RNA > 1,000 c/mL CD4 < 200/mm3 N = 94 LPV/r 400/100 mg BID + ZDV/3TC BID * * Substitution ABC for ZDV allowed *Randomisation was stratified by screening CD4 (> or < 100/mm3) Objective Non inferiority of EFV vs LPV/r at W48: % HIV RNA < 50 c/mL by intention to treat, missing equals failure, TLOVR analysis (lower margin of the 2-sided 95% CI for the difference = - 12%) Sierra-Madero J. JAIDS 2010; 53:582-8 Mexican Trial
Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Baseline characteristics, patient disposition and primary endpoint at W48 EFV, N = 95 LPV/r, N = 94 p Median age, years 37 36 NS Female 17% 13% NS HIV RNA > 75,000 c/mL 87% 87% NS CD4 cell count (/mm3), median 64 52 NS CD4 < 50 per mm3 44% 48% NS Discontinuation by W48 28% 41% 0.05 For virologic failure N = 7 N = 17 0.02 For adverse event (including death) N = 5 (2) N = 11 (5) 0.1 HIV RNA < 50 c/mL at W48 ITT, TLOVR 67 / 95 (70.5%) 50 / 94 (53.2%) 95% CI for the difference: 3.5; 31 0.017 As Treated 50 / 78 (85.9%) 50 / 81 (61.7%) 0.0001 EFV superior to LPV/r Sierra-Madero J. JAIDS 2010; 53:582-8 Mexican Trial
Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Secondary endpoints HIV RNA < 50 c/mL at W48 according to baseline CD4 Baseline CD4 < 100/mm3 : EFV > LPV/r (p = 0.03) Baseline CD4 > 100/mm3 : virologic response to EFV and LPV/r not different (p = 0.11) Similar CD4+ cell count increase in both groups Incidence of grade 2 to 4 adverse events similar between groups: 68% Significantly greater increase in triglyceride levels in LPV/r arm vs EFV (p < 0.01) Changes in total cholesterol, HDL, and LDL similar between groups At virologic failure, only few patients were genotyped: LPV/r, N = 5/17: no PI resistance, NRTI resistance in 1 EFV, N = 3/7: NNRTI resistance in 3, NRTI resistance in 2 Sierra-Madero J. JAIDS 2010; 53:582-8 Mexican Trial
Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Conclusion In this very advanced HIV-infected antiretroviral-na ve population with a median CD4 closed to 50/mm3, EFV was virologically superior to LPV/r BID, when combined with ZDV/3TC EFV superiority was due to both a higher rate of virologic failure and of discontinuations due to adverse event in the LPV/r group Limits Single country study, limited sample size (underpowered) LPV/r soft-gel capsules and high pill burden associated with low tolerability and poor adherence in advanced HIV disease NRTI backbone: ZDV/3TC Sierra-Madero J. JAIDS 2010; 53:582-8 Mexican Trial
