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Related articles :

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Comparison of INSTI vs INSTI
Study GS-US-380-1489: BIC/F/TAF QD vs DTG/ABC/3TC QD
Original article : Gallant J. Lancet. 2017 Nov 4;390(10107):2063-2072.
Last update : 31/01/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

• Initial HIV-1 therapy with BIC/F/TAF was non inferior to DTG/ABC/3TC at W48 by snapshot algorithm
  • 92.4% of patients on BIC/F/TAF and 93.0% of patients on DTG/ABC/3TC had HIV-1 RNA < 50 copies/mL
  • Sensitivity analyses confirmed non inferiority
• No treatment emergent resistance
• BIC/F/TAF was well tolerated, with no adverse events leading to discontinuation
  • Nausea was reported significantly more frequently in patients treated with DTG/ABC/3TC (p < 0.001)
  • Gastrointestinal, neuropsychiatric, and sleep-related symptoms were reported more frequently in patients treated with DTG/ABC/3TC
  • Changes from baseline in bone mineral density, lipid parameters and renal markers were comparable between treatment arms

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: 99.3%
  • DTG/ABC/3TC: 98.6%
    
    
• Met criteria for resistance testing (HIV RNA ≥ 200 c/mL)
  • BIC/F/TAF: 1 vs DTG/ABC/3TC: 4
  • No resistance emergence
    
    
• Mean CD4 increase at W48
  • BIC/F/TAF: + 233/mm3
  • DTG/ABC/3TC: + 229/mm3

Adverse events

* Nausea, rash ; thrombocytopenia ; chronic pancreatitis, steatorrhea ; depression
** p < 0.001

Renal parameters, bone mineral density and lipid changes at W48

• None of the differences between groups were significant
• No discontinuations due to renal adverse events and no proximal tubulopathy in either arm

Steady-state pharmacokinetic parameters of BIC/F/TAF (N = 17)

* BIC mean Ctau about 14 times higher than the protein adjusted effective concentration (162 ng/mL) against wild type HIV-1 virus.

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