Switch to BIC/FTC/TAF
GS-US-380-1878 Study: Switch to BIC/FTC/TAF
Original article : Daar ES. IDWeek 2017, Abs. LB4
Last update :
11/05/2018
Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK
- Switching to BIC/FTC/TAF was non-inferior to remaining on a boosted protease inhibitor + 2 NRTI
- 1.7% of subjects in each arm had HIV-1 RNA ≥ 50 c/mL through 48 weeks
- 92.1% of subjects treated with BIC/FTC/TAF maintained virologic suppression
vs 88.9% in the continuation arm
- No treatment emergent resistance in patients who switched to BIC/FTC/TAF
- 1 subject who continued DRV/r + ABC/3TC developed resistance mutation to ABC
- BIC/FTC/TAF was well tolerated
- Adverse events were comparable between arms at week 48
- mild headache was reported more with BIC/FTC/TAF but was mostly transient and low grade
- Less than 1% of patients discontinued due to an adverse event in both arms
- No difference in grade 3 or 4 laboratory abnormalities between arms, except for more total bilirubin abnormalities in continuation arm due to ATV use
- Statistically significant improvements in triglycerides and total cholesterol:HDL ratio in subjects who switched to BIC/FTC/TAF
Design
Endpoint
- Primary: proportion of patients with HIV RNA ≥ 50 c/mL at W48
(ITT, snapshot) ; non-inferiority if upper margin of a two-sided 95.002% CI
for the difference = 4%
Baseline characteristics and patient disposition
Virologic outcome at W48
- Patients analysed for resistance: 1 BIC/FTC/TAF vs 3 Continuation ART
- Emergence of resistance : 0/1 vs 1/3 (L74V in a patient on ABC/3TC + DRV/r)
Adverse events between D0 and W48, %
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 eGFRCG at W48:
- 4.3 mL/min BIC/FTC/TAF vs + 0.2 mL/min continuation ART (p < 0.001)
Median Fasting Lipid Changes at Week 48 (mg/ dL )
- Taking lipid lowering agents at baseline:
B/F/TAF : 16.2%, Continuation ART : 15.7%, p = 0.91
- Initiated lipid lowering agents during the study: B/F/TAF : 2.8%, Continuation ART: 3.5%, p = 0.64
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