1. Comparison of PI vs PI ATV vs ATV/r BMS 089
ARV-trial.com
ARV-trial.com
ATV vs ATV/r BMS 089
LPV/r mono vs LPV/r + ZDV/3TC MONARK
LPV/r QD vs BID M M A5073
LPV/r + 3TC vs LPV/r + 2 NRTI GARDEL
ATV/r vs FPV/r ALERT
ATV/r vs DRV/r ATADAR
FPV/r vs LPV/r KLEAN
SQV/r vs LPV/r GEMINI
ATV/r vs LPV/r CASTLE
DRV/r vs LPV/r ARTEMIS
DRV/r + 3TC vs DRV/r + 3TC/TDF ANDES 1 1

2. ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
ARV-trial.com
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
Design
Randomisation*
1 : 1
Open-label
W48
> 18 years
ARV-naïve
HIV RNA > c/mL
Any CD4 cell count
HBsAg negative
No R to study drugs
N = 75
DRV/r 800/100 mg FDC + 3TC 300 mg QD
N = 74
DRV/r 800/100 mg FDC + 3TC/TDF QD
*Randomisation was stratified by HIV RNA (< or > c/mL) at screening
Objective
Non inferiority of DRV/r + 3TC at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis
ANDES
Figueroa MI, CROI 2018, Abs. 489 2

3. ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
ARV-trial.com
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
Baseline characteristics and patient disposition
DRV/r + 3TC
N = 75
DRV/r + 3TC/TDF
N = 74
Median age, years 30
Female, % 7 12
HIV RNA (log10 c/mL), median
4.6
4.5
HIV RNA > c/mL, % 27 22
CD4 cell count (/mm3), median
419
367
Discontinuation by W24, N
Adverse event
Lost to follow-up
Withdrew consent 4 2 1
ANDES
Figueroa MI, CROI 2018, Abs. 489 3

4. ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
ARV-trial.com
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
Efficacy outcome at W48
DRV/r + 3TC
N = 75
DRV/r + 3TC/TDF
N = 74
HIV RNA < 50 c/mL, % 93 94
Difference : %
(95% CI : to 5.6)
HIV RNA < 50 c/mL in patients with baseline HIV RNA > c/mL, % 91 92
Median CD4 increase (/mm3)
246
200
p = 0.20
Safety at W48
DRV/r + 3TC
N = 75
DRV/r + 3TC/TDF
N = 74
Grade 2-4 adverse events possibly/probably related, N 11 17
Gastro-intestinal adverse events, % 7%
14%
Rash, % 8%
Total cholesterol elevation
LDL-cholesterol elevation
Triglycerides elevation
19%
25%
4% (p = 0.01)
6% (ns)
14% (ns)
No treatment-related serious adverse event
ANDES
Figueroa MI, CROI 2018, Abs. 489 4

5. ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
ARV-trial.com
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF
Summary
DRV/r + 3TC dual therapy was virologically non inferior to a standard therapy of DRV/r + 3TC/TDF in naïve patients
Similar virologic response of the 2 regimens in patients with HIV RNA > c/mL at enrolment
Only 1 case of virologic failure (DRV/r + 3TC/TDF) with no emergence of resistance
Incidence of gastro-intestinal adverse events higher in triple therapy group
Lipid elevations higher in the DRV/r + 3TC group, significantly higher than in DRV/r + 3TC/TDF group for total cholesterol
ANDES
Figueroa MI, CROI 2018, Abs. 489 5