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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 • ACTG A5142 • EFV vs LPV/r • Mexican Study • NVP vs ATV/r • ARTEN • EFV vs ATV/r • ACTG A5202

  2. ARTEN Study: NVP vs ATV/r, in combination with TDF/FTC • Design Randomisation * 1:1:1 Open-label W48 W144 N = 188 > 18 years ARV-naïve or < 7 days of prior ARV exposure CD4 cell count < 400/mm3 in male, < 250/mm3 in female * Lead-in dose of NVP 200 mg QD for the first 14 days N = 188 N = 193 *Randomisation was stratified by HIV RNA (< or > 100,000 c/mL) and CD4 (< or > 50/mm3) at screening • Objective • Non inferiority of NVP vs ATV/r at W48: % HIV RNA < 50 c/mL confirmed prior to W48 without subsequent rebound* or change of therapy by ITT, NC = F analysis (lower margin of the 2-sided 95% CI for the difference = - 12%) * HIV RNA < 50 c/mL at W24, W36 and W48 Soriano V, Antivir Ther. 2011;16(3):339-48 ARTEN

  3. ARTEN Study: NVP vs ATV/r, in combination with TDF/FTC Baseline characteristics and patient disposition Patients with HBsAg+ or HCV RNA+, and AST/ALT > 2.5 x ULN were excluded NVP group received a lead-in dose of NVP 200 mg QD for the first 14 days Soriano V, Antivir Ther. 2011;16(3):339-48 ARTEN

  4. ARTEN Study: NVP vs ATV/r, in combination with TDF/FTC Outcome at week 48 HIV RNA < 50 c/mL (ITT, NC= F) * HIV RNA < 50 c/mL confirmed prior to W48 without subsequent rebound or change of therapy Treatment response NVP QD = 67%; NVP BID = 66.5% NVP (N = 376) % ATV/r (N = 193) 100 Primaryanalysis Mean CD4/mm3 increase at W48 (on treatment analysis): 170 (NVP) vs 185 (ATV/r) (p = 0.18) 73.6 70.2 75 66.8 65.3 Virologic failure rates and causes 50 25 *CVR, NC = F TLOVR 95% CI for the difference = - 5.9; 9.8 95% CI for the difference = - 10.4; 4.5 Soriano V, Antivir Ther. 2011;16(3):339-48 ARTEN

  5. Safety Incidence of discontinuation due to adverse event: 13.6% NVP vs 3.6% ATV/r Rash: 16% NVP vs 12.4% ATV/r (discontinuation due to rash : 5.1% vs 0%) Hepatitis: 1.9% NVP vs 0% ATV/r Grade 3-4 liver enzyme elevations: 4% NVP vs 1.5% ATV/r Grade 3-4 hyperbilirubinemia:3.2% NVP vs 54.4% ATV/r No cases of Stevens-Johnson, toxic epidermal necrolysis, or death due to liver or skin toxicity p < 0.0001 30 p = 0.041 28.1 25 24.3 20 p = 0.011 19.6 15 p < 0.0001 15.0 10 10.5 9.7 5 3.9 -0.2 0 Totalcholesterol LDL-C HDL-C Triglycerides - 5 NVP ATV/r ARTEN Study: NVP vs ATV/r, in combination with TDF/FTC Mean change in lipid parameters (mg/dL) at week 48 (LOCF) 0.2 0.1 0.13 Mean change in TC:HDL ratio at week 48(LOCF) 0 -0.1 -0.24 p = 0.0001 -0.2 Soriano V, Antivir Ther. 2011;16(3):339-48 -0.25 ARTEN

  6. Summary - Conclusion NVP was virologically non-inferior at W48 to ATV/r, in combination with TDF/FTC Immunologic response was similar for NVP and ATV/r NVP demonstrated a more favourable lipid profile than ATV/r Both NVP regimens were similar in terms of virologic response and safety Rates and severity of adverse events were similar between groups, but discontinuations due to adverse event were more frequent in NVP than in ATV/r patients For patients with CD4 count < 250/mm3 in women and < 400/mm3 in men, NVP + TDF/FTC is an alternative to ATV/r + TDF/FTC for first-line antiretroviral therapy ARTEN Study: NVP vs ATV/r, in combination with TDF/FTC Soriano V, Antivir Ther. 2011;16(3):339-48 ARTEN