1. Comparison of INSTI – Phase 2
ARV-trial.com
Comparison of INSTI – Phase 2
BIC Phase 2 Study

2. BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF
ARV-trial.com
BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF
Design
Randomisation
2:1
Double-blind
W24
W48
> 18 years
ARV-naïve
HIV RNA > c/mL
CD4 ≥ 200/mm3
HBs Ag and HCV Ab
negative
N = 65
BIC + FTC/TAF + DTG placebo
DTG + FTC/TAF + BIC placebo
N = 33
BIC: 75 mg QD
DTG: 50 mg QD
Objective
% HIV RNA < 50 c/mL at W24
BIC Phase 2
Sax PE. Lancet HIV 2017; 4:e154-e160

3. BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF
ARV-trial.com
BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF
Baseline characteristics and patient disposition
BIC + FTC/TAF
N = 65
DTG + FTC/TAF
N = 33
Median age, years 30 36
Female, % 2 9
Race : white, % 58 55
HIV RNA (log10 c/mL), median
4.41
4.48
HIV RNA > c/mL, % 15 21
CD4 cell count (/mm3), median
441
455
CD4 < 200 per mm3, % 5
Median eGFR (Cockroft-Gault), mL/min
130
122
Premature discontinuation, N
Adverse event
Lost to follow-up
Non-compliance 1
BIC Phase 2
Sax PE. Lancet HIV 2017; 4:e154-e160

4. BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF
ARV-trial.com
BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF 58
HIV RNA < 50 c/mL (ITT, snapshot)
W24 (primary endpoint) 97 2 91 6 3 20 40 60 80
100
Virologic
response
non-response
No data %
W48
Difference (95% CI) = 6.4% (- 6.0 to 18.8) 97 3 94 6 20 40 60 80
100
Virologic
response
failure
No data %
Difference (95% CI) = 2.9% (- 8.5 to 14.2)
DTG + FTC/TAF (N = 33)
BIC + FTC/TAF (N = 65)
CD4 increase at W48 (mean) BIC: + 258/mm3 vs DTG: + 192/mm3
BIC Phase 2
Sax PE. Lancet HIV 2017; 4:e154-e160

5. BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF
ARV-trial.com
BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF 62
Adverse events, %
BIC + FTC/TAF
N = 65
DTG + FTC/TAF N = 33
Adverse event ≥ 5% in either group
Diarrhea
Nausea
Headache
Upper respiratory tract infection
Fatigue
Arthralgia
Chlamydial infection
Back pain
Furuncle
Flatulence
Gastroenteritis
Costochondritis
Hemorrhoids
Pruritis
Grade 2-4 laboratory abnormalities ≥ 8% in either group
Creatine kinase
AST
Hyperglycemia
LDL-cholesterol 13 9 8 6
1 patient in the BIC + FTC/TAF group with a past history of urticaria and atopic dermatitis discontinued study drug after W24 due to urticaria
BIC Phase 2
Sax PE. Lancet HIV 2017; 4:e154-e160