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

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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