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Comparison of NNRTI vs PI/r

Comparison of NNRTI vs PI/r

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Comparison of NNRTI vs PI/r

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  1. Comparison of NNRTI vs PI/r • EFV vs LPV/r vs EFV + LPV/r • A5142 • MexicanStudy • NVP vs ATV/r • ARTEN • EFV vs ATV/r • A5202

  2. Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Mexican Trial • Design Randomisation* 1 : 1 Open-label W48 N = 95 > 18 years ARV-naïve HIV RNA > 1,000 c/mL CD4 < 200/mm3 N = 94 * 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

  3. Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Mexican Trial Baseline characteristics, patient disposition and primary endpoint at W48  EFV superior to LPV/r Sierra-Madero J. JAIDS 2010; 53:582-8

  4. 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 Mexican Study: EFV vs LPV/r, in combination with ZDV/3TC Mexican Trial Sierra-Madero J. JAIDS 2010; 53:582-8

  5. Conclusion In this very advanced HIV-infected antiretroviral-naïve 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 Mexican Trial Mexican Study:EFV vs LPV/r, in combination with ZDV/3TC Sierra-Madero J. JAIDS 2010; 53:582-8