Switch studies in virologically suppressed patients

Switch to BIC/FTC/TAF
GS-US-380-1961 Study : Switch to BIC/FTC/TAF
Original article : Kityo C. CROI 2018, Abs. 500
Last update : 11/05/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Switching to BIC/FTC/TAF was non inferior to continuing ATV-
    and EVG-based regimens at Week 48, in women
    • 1.7% of participants in both groups had HIV-1 RNA ≥ 50 c/mL
    • 96% of women treated with BIC/FTC/TAF maintained
      HIV-1 RNA < 50 c/mL vs 95% with continuation of ART
  • No treatment-emergent resistance was observed in women receiving BIC/FTC/TAF
  • BIC/FTC/TAF was well tolerated, and no adverse event led to discontinuation
  • Changes from baseline in lipid parameters and renal markers were comparable between treatment arms

Design

Endpoints

  • Primary: proportion of patients with HIV RNA ≥ 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if upper margin of a two-sided 95.001% CI for the difference = 4%
  • Secondary: proportion of patients with HIV RNA < 50 c/mL at W48 (ITT, snapshot)

Baseline characteristics and patient disposition

Virologic outcome at W48

  • Emergence of resistance in BIC/FTC/TAF: 0/1 patient analysed for resistance
  • Emergence of resistance in Continuation ART:1/2 patients analysed for resistance (M184I/V)

Adverse events between D0 and W48, %


* Headache (N = 2), vomiting (N = 1), cerebrovascular accident (N = 1), abnormal dreams (N = 1),
suicidal ideation (N = 1) ; ** headache (N = 1), pruritus (N = 1)

Median change in eGFRCG at W48

  • - 1.8 mL/min BIC/FTC/TAF vs - 2.7 mL/min Continuation ART (p = 0.70)

Median percent change in quantitative proteinuria at W48


UACR: urine albumin:creatinine ratio ; RBP: retinol-binding protein ; β-2- m: beta-2 microglobulin

Median % change in fasting lipids at W48

 

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