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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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