1. Switch to BIC/FTC/TAF
GS-US
GS-US
GS-US

2. GS-US-380-1961 Study: Switch to BIC/FTC/TAF
Design
Randomisation
1 : 1
Open-label
W48
HIV+ ≥ 18 years
Women
On E/C/F/TAF or TDF or ATV/r + FTC/TDF
HIV RNA < 50 c/mL ≥ 6 months
eGFR (Cockroft-Gault) > 50 mL/min
N = 234
BIC/FTC/TAF 50/200/25 mg QD
BIC/FTC/TAF
Continuation of baseline ART
N = 236
Endpoints
Primary: proportion of patients with HIV RNA ≥ 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if upper margin of a two-sided % CI for the difference = 4%
Secondary: proportion of patients with HIV RNA < 50 c/mL at W48 (ITT, snapshot)
GS-US
Kityo C. CROI 2018, Abs. 500

3. GS-US-380-1961 Study: Switch to BIC/FTC/TAF
Baseline characteristics and patient disposition
BIC/FTC/TAF
N = 234
Continuation ART
N = 236
Median age, years 39 40
Ethnicity: white / black / hispanic, %
25 / 39 / 15
480
CD4 cell count (/mm3), median
667
704
eGFR (Cockroft-Gault), mL/min, median
99.6
102.0
ARV regimen at randomisation, %
E/C/F/TAF
E/C/F/TDF
ATV/r + FTC/TDF 53 42 6
Discontinuation by W48, N (%)
For adverse event, N
Lost to follow-up, N
Investigator discretion, N
Pregnancy, N
Death, N
3 (1.3%) 3
5 (2.1%) 1 2
GS-US
Kityo C. CROI 2018, Abs. 500

4. GS-US-380-1961 Study: Switch to BIC/FTC/TAF
Virologic outcome at W48
BIC/FTC/TAF (N = 234)
Continuation ART (N = 236)
Difference : 0.0%
(95.001% CI : to 2.9) 2 96 3 95
HIV RNA < 50 c/mL
No virologic data 20 40 60 80
100 %
HIV RNA ≥ 50 c/mL
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)
GS-US
Kityo C. CROI 2018, Abs. 500

5. Adverse events between D0 and W48, %
GS-US Study: Switch to BIC/FTC/TAF
Adverse events between D0 and W48, %
BIC/FTC/TAF
N = 234
Continuation ART
N = 236
Discontinuation for adverse event
Adverse event in ≥ 5% of either arm, %
Nasopharyngitis
Urinary tract infection
Upper respiratory tract infection
Headache
Vulvovaginal candidiasis 8 7 6 5 2 4
Any study-drug related adverse event
20 (9%)
13 (6%)
Grade 3-4 laboratory abnormalities, %
Urine red blood cell count
LDL-cholesterol
Amylase
Total cholesterol 11 3
< 1 1
Median change in eGFRCG at W48:
- 1.8 mL/min BIC/FTC/TAF vs mL/min Continuation ART (p = 0.70)
GS-US
Kityo C. CROI 2018, Abs. 500

6. GS-US-380-1961 Study: Switch to BIC/FTC/TAF
Median percent change in quantitative proteinuria at W48
Baseline TDF-containing regimen
Baseline non-TDF-containing regimen
BIC/FTC/TAF
Continuation ART
UACR p = 0.40
RBP:Cr p < 0.001
β-2-m:Cr p < 0.001
UACR p = 0.09
RBP:Cr p = 0.14
β-2-m:Cr p = 0.19 80 60 40 20 17 20 10 11 7 -4 -4
-20 -9 -7
-40
-27
-29
UACR: urine albumin:creatinine ratio ; RBP: retinol-binding protein ; β-2-m: beta-2 microglobulin
GS-US
Kityo C. CROI 2018, Abs. 500

7. Median % change in fasting lipids at W48
GS-US Study: Switch to BIC/FTC/TAF
Median % change in fasting lipids at W48
Total
cholesterol ns
LDL-
cholesterol ns
HDL-
cholesterol ns
Triglycerides p < 0.001 10
-10
-20 4 -1 -3 -4
GS-US
Kityo C. CROI 2018, Abs. 500

8. GS-US-380-1961 Study: Switch to BIC/FTC/TAF
Conclusion
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
GS-US
Kityo C. CROI 2018, Abs. 500