1 / 5

Comparison of NNRTI vs PI/r

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. Mexican Trial. Design. Randomisation* 1 : 1 Open-label. W48. N = 95. > 18 years ARV-naïve

devika
Télécharger la présentation

Comparison of NNRTI vs PI/r

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related