1. Comparison of INSTI vs PI
ARV-trial.com
Comparison of INSTI vs PI
FLAMINGO GS
ACTG A5257
WAVES
ARIA 1

2. ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
ARV-trial.com
ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
Design
Randomisation*
1 : 1
Open label
W48
N = 248
extension
Women
ARV-naive
HIV RNA > 500 c/mL
Any CD4 cell count
HLA-B*5701 negative
Hepatitis B negative
DTG/ABC/3TC QD
N = 247
ATV + r 300/100 mg + FTC/TDF QD
* Randomisation was stratified by HIV RNA (≤ or > c/mL) at screening and CD4 (≤ or > 350/mm3)
Objective
Non inferiority of DTG/ABC/3TC at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (lower margin of the 2-sided 95% CI for the difference = - 12%)
ARIA
Orrell C. AIDS 2016, Durban, Abs. THAB0205LB 2

3. ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
ARV-trial.com
ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
Baseline characteristics and patient disposition
DTG/ABC/3TC
N = 248
ATV + r + FTC/TDF
N = 247
Female, %
100
Median age, years
37.5 37
White / Black / Asian, %
46 / 41 / 9
43 / 44 / 9
AIDS, % 4
HIV RNA (log10 c/mL), median
4.48
4.44
HIV RNA > c/mL, % 28 27
CD4 cell count (/mm3), median
370
380
CD4 < 350 per mm3, % 52 50
Hepatitis C coinfection, % 6 9
Discontinuation by W48, N (%)
42 (17%)
55 (22%)
For lack of efficacy, N 5
For adverse event, N 10 18
Lost to follow-up / Withdrew consent, N
11 / 5
13 / 7
Protocol deviation/ Investigator discretion, N
10 / 1
13 / 0
13 patients: 5 DTG/ABC/3TC and 8 ATV/r + FTC/TDF became pregnant and were withdrawn from the study
ARIA
Orrell C. AIDS 2016, Durban, Abs. THAB0205LB 3

4. ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
ARV-trial.com
ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
Response to treatment at week 48
HIV RNA < 50 c/mL (ITT-E, snapshot)
HIV RNA < 50 c/mL at W48 (%)
DTG/ABC/3TC (N = 248)
ATV + r + FTC/TDF (N = 247) 25 50
100 75 82 71
Adjusted difference
(95% CI) =
10.5 % (3.1 ; 17.8)
p = 0.005 6 14
Virologic success
Virologic failure % 12 15
No virologic
data
DTG/ABC/3TC
ATV + r + FTC/TDF
Per protocol 86 76
ITT, by baseline strata
HIV RNA ≤ 105 c/mL 83 74
HIV RNA > 105 c/mL 80 64
CD4 ≤ 350/mm3 85 72
CD4 > 350/mm3 78 71
Emergence of resistance
Confirmed virologic failure (HIV RNA ≥ 400 c/mL): 6 DTG/ABC/3TC vs 4 ATV + r + FTC/TDF
Mutations emergence at failure
DTG/ABC/3TC, N = 1 (K219K/Q + E138E/G)
ATV + r + FTC/TDF, N = 1 (M184V)
ARIA
Orrell C. AIDS 2016, Durban, Abs. THAB0205LB 4

5. ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
ARV-trial.com
ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
Adverse events
DTG/ABC/3TC
ATV + r + FTC/TDF
Grade 2 to 4 adverse events, N (%)
115 (46)
137 (55)
Drug-related adverse events (≥ 5% in either arm), N (%)
Nausea
Diarrhea
Dyspepsia
Ocular icterus
Headache
Jaundice
83 (33)
31 (13)
12 (5)
4 (2)
5 (2)
121 (49)
35 (14)
18 (7)
15 (6)
14 (6)
13 (5)
Serious adverse events, N (%)
20 (8)
Fatal adverse events, N
1 (unrelated)
Drug-related serious adverse events, N 3
Discontinuation due to adverse events, N (%)
10 (4)
17 (7)
Psychiatric adverse events, N (%)
Insomnia
Anxiety
Depression
Suicidal ideation
Depressed mood
Abnormal dreams
3 (1)
2 (< 1)
9 (4)
7 (3)
ARIA
Orrell C. AIDS 2016, Durban, Abs. THAB0205LB 5

6. ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
ARV-trial.com
ARIA Study: DTG/ABC/3TC QD vs ATV + r + FTC/TDF QD in Women
Conclusion
In treatment-naive women, DTG/ABC/3TC was superior to ATV + r + TDF/FTC at 48 weeks of treatment
HIV RNA < 50 c/mL (ITT-E, snapshot): 82% vs 71%
Adjusted difference 10.5%, 95% CI: 3.1% to 17.8%, p = 0.005
Difference driven by lower rate of virologic non-response and fewer discontinuations due to adverse events in DTG arm
DTG/ABC/3TC had a favorable safety profile compared to ATV + r + TDF/FTC
ARIA
Orrell C. AIDS 2016, Durban, Abs. THAB0205LB 6