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

Comparison of INSTI vs INSTI
ONCEMRK Study: raltegravir 1200 mg QD vs 400 mg BID, with TDF/FTC
Original article : Cahn P. AIDS 2016, Durban, Abs. FRAB0103LB
Last update : 06/09/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • In HIV-1 treatment-naive patients, RAL 1200 mg (two 600 mg reformulated tablets) QD has potent and durable efficacy comparable
    to RAL 400 mg BID each in combination with TDF/FTC:
    • Statistically non-inferior antiretroviral activity of RAL 1200 mg QD compared to RAL 400 mg BID, with 88% achieving HIV RNA < 40 copies/mL at week 48
    • High and similar rates of virologic suppression, irrespective of baseline HIV RNA
    • Large increases in CD4 count (232 cells/mm3) comparable
      to RAL 400 mg BID (234 cells/mm3) at Week 48
  • RAL 1200 mg QD was generally well tolerated
    • Overall safety profile similar to RAL 400 mg BID
  • Reformulated once-daily raltegravir may offer a new potent, well tolerated, and convenient option for initial treatment of HIV infection

Design


*Randomisation was stratified by baseline HIV RNA ( < or > 100 000 c/mL) and viral hepatitis co-infection status
** Reformulated RAL 600 mg tablet

Objective

  • Non inferiority of RAL QD: % HIV RNA < 40 c/mL by ITT, NC=F (lower margin of the 2-sided 95% CI for the difference = - 10%, 90% power)

Baseline characteristics and patient disposition

HIV RNA < 40 c/mL (NC = F ; snapshot), % (95% CI)

  • CD4/mm3 increase at W48 (observed failure): QD = + 232 vs BID = + 234 ; Δ∆ -2 (- 31 ; 27)

Virologic failure

  • Non response: did not achieve HIV RNA < 40 c/ mL by W24
  • Rebound: 2 consecutive measurements of HIV-1 RNA ≥ 40 c/mL at least 1 week apart after initial response of HIV RNA < 40 c/ mL

Clinical adverse events , %

   

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