Head-to-head comparative trials for first line ART since 2006

Comparison of INSTI vs PI
Study ARIA : DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
Original article : Orrell C. AIDS 2016, Durban, Abs. THAB0205LB
Last update : 06/09/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • In treatment-naive women, DTG/ABC/3TC was superior to
    ATV + r + TDF/FTC at 48 weeks of treatment
    • HIV RNA < 50 c/mL (ITT-E, snapshot): 82% vs 71%
    • Adjusted difference 10.5%, 95% CI: 3.1% to 17.8%, p = 0.005
    • Difference driven by lower rate of virologic non-response and fewer discontinuations due to adverse events in DTG arm
  • DTG/ABC/3TC had a favorable safety profile compared to
    ATV + r + TDF/FTC

Design


* Randomisation was stratified by HIV RNA (≤ or > 100 000 c/mL) at screening and CD4 (≤ or > 350/mm3)

Objective

  • Non inferiority of DTG/ABC/3TC at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (lower margin of the 2-sided 95% CI for the difference = - 12%)

Baseline characteristics and patient disposition


13 patients: 5 DTG/ABC/3TC and 8 ATV/r + FTC/TDF became pregnant and were withdrawn from the study

Response to treatment at week 48


Adjusted difference (95% CI) = 10.5 % (3.1 ; 17.8) p = 0.005

Emergence of resistance

  • Confirmed virologic failure (HIV RNA ≥ 400 c/mL): 6 DTG/ABC/3TC vs 4 ATV + r + FTC/TDF
  • Mutations emergence at failure
    • DTG/ABC/3TC, N = 1 (K219K/Q + E138E/G)
    • ATV + r + FTC/TDF, N = 1 (M184V)

Adverse events

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