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

Comparison of INSTI vs INSTI
Study GS-US-380-1490: BIC/F/TAF QD vs DTG + F/TAF QD
Original article : Sax PE. Lancet. 2017 Nov 4;390(10107):2073-2082.
Last update : 31/01/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Virologic suppression at W48 was high in both arms, with BIC/F/TAF being non inferior to DTG + F/TAF in treatment-naïve adults
    • Sensitivity analyses confirmed BIC/F/TAF was non inferior to DTG + F/TAF
    • No patient discontinued either treatment arm due to lack of efficacy
  • No treatment-emergent resistance to any study medication was observed in either arm
  • BIC/F/TAF was safe and well tolerated
    • Less decrease in eGFRCG was observed with BIC/F/TAF vs DTG + F/TAF
    • There were no discontinuations due to renal adverse events and no cases of renal tubulopathy, including Fanconi syndrome, in either treatment group
    • Changes from baseline in lipid parameters were equivalent

Design


* Randomisation was stratified by HIV RNA (< 100 000 c/mL, 100 000-4000 000 c/mL or > 100 000 c/mL), CD4 (< 50/mm3, 50-199/mm3 or ≥ 200/mm3) at screening and geographic region (USA vs non-USA)

BIC/F/TAF : 50/200/25 mg, as STR

Objective

  • Non inferiority of BIC/F/TAF at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (lower margin of the 2-sided 95.002% CI for the difference= -12%, 95% power)

Baseline characteristics and patient disposition

Virologic outcome at week 48

  • HIV RNA < 50 c/mL (per-protocol)
    • BIC/F/TAF: 98.9%
    • DTG + F/TAF: 99.7%
  • Met criteria for resistance testing (HIV RNA ≥ 200 c/mL)
    • BIC/F/TAF: 7 vs DTG + F/TAF: 5
    • No resistance emergence
  • Mean CD4 increase at W48
    • BIC/F/TAF: + 180/mm3
    • DTG + F/TAF: + 201/mm3

Adverse events

* Abdominal distension ; Cardiac arrest (sepsis, appendicitis) ; Chest pain ; Paranoia, crystal metamphetamine
use ; sleep disorders, insomnia, dyspepsia, tension headache, depressed mood
** Erythema, pruritus

Change from baseline in eGFR and lipids at W48

  • No discontinuations due to renal adverse events and no proximal tubulopathy in either arm

Resistance data at W96

* N = 15
** BIC mean Ctau about 16 times higher than the protein adjusted effective concentration (162 ng/mL) against wild type HIV-1 virus

 

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