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Comparison of INSTI vs PI

Comparison of INSTI vs PI. FLAMINGO GS-236-0103 ACTG A5257. FLAMINGO Study : DTG QD + 2 NRTI vs DRV/r QD + 2 NRTI. Design. Randomisation* 1 : 1 Open-label. W48. W96. > 18 years ARV-naïve HIV RNA > 1,000 c/mL Any CD4 cell count No primary resistance in RT or protease. N = 243.

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Comparison of INSTI vs PI

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  1. Comparison of INSTI vs PI • FLAMINGO • GS-236-0103 • ACTG A5257

  2. FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI • Design Randomisation* 1 : 1 Open-label W48 W96 > 18 years ARV-naïve HIV RNA > 1,000 c/mL Any CD4 cell count No primary resistance in RT or protease N = 243 N = 245 *Randomisation (DTG vs DRV/r) was stratified by HIV RNA (< or > 100,000 c/mL) at screening and NRTI backbone **NRTI backbone (TDF/FTC or ABC/3TC if exclusion of the HLA-B*5701 allele) was selected by investigator • Objective • Non inferiority of DTG at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (1-sided significance level of 2.5%, lower margin of the 95% CI for the difference = -12%, 90% power) FLAMINGO Clotet B. Lancet 2014;383;2222-31

  3. FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI Baseline characteristics and patient disposition FLAMINGO Clotet B. Lancet 2014;383;2222-31

  4. FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI Response to treatment at week 48 HIV RNA < 50 c/mL DTG + 2 NRTI % Primary analysis DRV/r + 2 NRTI 100 91.1 89.7 83.8 82.6 • Protocol-defined virologic failures (2 consecutive HIV RNA > 200 c/mLon or after W24) • 2 on DTG + NRTI (TDF/FTC) • 2 on DRV/r + NRTI (ABC/3TC) • No resistance emergence in the 4 cases 75 50 25 0 ITT, snapshot Per protocol Median CD4/mm3 increase at W48 : + 210 in both groups Adjusted difference (95% CI)= 7.1% (0.9 ; 13.2) Adjusted difference (95% CI)= 7.4% (-1.4 ; 13.3) FLAMINGO Clotet B. Lancet 2014;383;2222-31

  5. FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI HIV-1 RNA < 50 c/mL at week 48 by stratification factors (HIV-1 RNA and background NRTI) FLAMINGO Clotet B. Lancet 2014;383;2222-31

  6. FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI Adverse events occurring in > 5% in either group at week 48 FLAMINGO Clotet B. Lancet 2014;383;2222-31

  7. FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI Safety at week 48 FLAMINGO Clotet B. Lancet 2014;383;2222-31

  8. Conclusion DTG 50 mg QD achieved higher virologic success at week 48, than DRV/r QD, when combined with either TDF/FTC or ABC/3TC In patients with high baseline viral load, the response rate was higher for DTG No resistance mutations were detected through 48 weeks in the 2 groups Adverse events leading to discontinuation occurred less frequently in the DTG group No specific trends in adverse events With the exception of 2 patients reporting suicide attempt and overdose on DTG No discontinuation due to renal events Mean increases in creatinine with accompanying decreases in estimated glomerular filtration rate occurred by week 4, and stabilized up to week 48 Once-daily DTG in combination with fixed-dose NRTIs represents an effective treatment option for HIV-1-infected, treatment-naive patients FLAMINGO Study: DTG QD + 2 NRTI vs DRV/r QD+ 2 NRTI FLAMINGO Clotet B. Lancet 2014;383;2222-31

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