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

2. GS-US-380-1878 Study: Switch to BIC/FTC/TAF
Design
Randomisation
1 : 1
Open-label
W48
N = 290
BIC/FTC/TAF 50/200/25 mg QD
HIV+ ≥ 18 years
On boosted ATV or DRV
+ 2 NRTI (ABC/3TC or FTC/TDF)
HIV RNA < 50 c/mL ≥ 6 months
eGFR (Cockroft-Gault) > 50 mL/min
Continuation of baseline ART
N = 287
Endpoint
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%
GS-US
Daar ES. IDWeek 2017, Abs. LB4

3. GS-US-380-1878 Study: Switch to BIC/FTC/TAF
Baseline characteristics and patient disposition
BIC/FTC/TAF
N = 290
Continuation ART
N = 287
Median age, years 48 47
Female, % 16 18
Ethnicity: white / black / hispanic, %
52 / 27 / 21
59 / 25 / 16
CD4 cell count (/mm3), median
617
626
HBV / HCV co-infection, %
8 / 5
6 / 5
eGFR (Cockroft-Gault), mL/min, median
107
105
Discontinuation by W48, N (%)
For adverse event, N
For lack of efficacy, N
Investigator discretion, N
Consent withdrawal, N
Loss to follow-up, N
Non-compliance, N
Protocol violation, N
Death, N
16 (5.5%) 2 1 9
26 (9.1%) 14 3 5
GS-US
Daar ES. IDWeek 2017, Abs. LB4

4. GS-US-380-1878 Study: Switch to BIC/FTC/TAF
Virologic outcome at W48
BIC/FTC/TAF (N = 290)
Continuation ART (N = 287)
Difference : 0%
(95.002% CI: to 2.5)
1.7
92.1
6.2
88.9
9.4
HIV RNA < 50 c/mL
No virologic
data 20 40 60 80
100
Difference : 3.3%
(95.002% CI : to 8.2) %
HIV RNA ≥ 50 c/mL
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)
GS-US
Daar ES. IDWeek 2017, Abs. LB4

5. Adverse events between D0 and W48, % Fracture/acute kidney injury
GS-US Study: Switch to BIC/FTC/TAF
Adverse events between D0 and W48, %
BIC/FTC/TAF
N = 290
Continuation ART
N = 287
Discontinuation for adverse event, N 2
Rash ; Schizophrenia 1
Fracture/acute kidney injury
Adverse event in ≥ 5% of either arm, %
Headache
Diarrhea
Nasopharyngitis
Upper respiratory tract infection
Back pain
Arthralgia
12 8
Grade 3-4 laboratory abnormalities, %
LDL-cholesterol
Amylase
Glycosuria
ALT
Total bilirubin
Total cholesterol
Hematuria
GS-US
Daar ES. IDWeek 2017, Abs. LB4

6. GS-US-380-1878 Study: Switch to BIC/FTC/TAF
Median percent change in quantitative proteinuria at W48
Baseline FTC/TDF-containing regimen
Baseline ABC/3TC-containing regimen
BIC/FTC/TAF
Continuation ART
RBP:Cr
β-2-m:Cr
UACR % 40 30 20 10
-10
-20
-30
-40
-50
-2.1
9.9
-17.7
-40.3
34.9
31.6
RBP:Cr
β-2-m:Cr
UACR % 40 30 20 10
-10
-20
-30
-40
-50
4.2
1.1
5.4
-19.5
7.3
25.8
UACR: urine albumin:creatinine ratio ; RBP: retinol-binding protein ; β-2-m: beta-2 microglobulin
Median change in eGFRCG at W48: mL/min BIC/FTC/TAF vs mL/min continuation ART (p < 0.001)
GS-US
Daar ES. IDWeek 2017, Abs. LB4

7. Total Cholesterol: HDL
GS-US Study: Switch to BIC/FTC/TAF
Median Fasting Lipid Changes at Week 48 (mg/dL)
BIC/FTC/TAF
Continuation ART
Total Cholesterol
LDL Cholesterol
Triglycerides
HDL Cholesterol
p = 0.32
p = 0.47
p = 0.13
p = 0.002 30 20 10
-10
-20
-30 1 5 3 -6 4
Total Cholesterol: HDL
p = 0.033
-0,2
1,5
1,0
0,5
0,0
-0,5
-1,0
-1,5
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
GS-US
Daar ES. IDWeek 2017, Abs. LB4

8. GS-US-380-1878 Study: Switch to BIC/FTC/TAF
Conclusions
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
GS-US
Daar ES. IDWeek 2017, Abs. LB4