1. Switch to DTG + 3TC
ASPIRE Study

2. ASPIRE Study: switch to DTG + 3TC
Design
Randomisation
1: 1
Open-label
W24
W48
≥ 18 years
Stable triple ART ≥ 48 weeks with ≥ 2 HIV RNA < 50 c/mL during past 48 weeks
Screening HIV RNA < 20 c/mL
No NRTI resistance mutation on
pre-treatment genotype
No history of virologic failure
HBs Ag negative
DTG 50 mg + 3TC 300 mg QD
N = 44
Continuation of current 3-drug ARV regimen
N = 45
Objective
Primary Endpoint: proportion with treatment failure (virologic failure, loss to follow-up, discontinuation/modification of treatment) at W24
Virologic failure: confirmed HIV RNA > 50 c/mL
Non-inferiority of DTG + 3TC (margin of 12%, 80% power)
ASPIRE
Taiwo BO. Clin Infect Dis Dec 26 (ePub ahead of print)

3. Baseline characteristics and disposition Continuation triple ART
ASPIRE Study: switch to DTG + 3TC
Baseline characteristics and disposition
DTG + 3TC
N = 44
Continuation triple ART
N = 45
Median age, years 46 50
Female, % 11 13
Baseline CD4/mm3, median (IQR)
694 ( )
646 ( )
Nadir CD4/mm3, median (IQR)
333 ( )
228 (91-341)
Current antiretroviral therapy, %
NNRTI
PI/r
INI
TDF/FTC / ABC/3TC
/ 18
91 / 9
Discontinued at W48, N 3
Adverse event 1
Virologic rebound
Lost to follow-up
Physician decision 2
ASPIRE
Taiwo BO. Clin Infect Dis Dec 26 (ePub ahead of print)

4. ASPIRE Study: switch to DTG + 3TC
107
Virologic outcome at W24 and W48(ITT, snapshot)
Primary endpoint:
Treatment failure %
100
DTG + 3TC (N = 44) %
93.2
90.9
91.1
88.9
Continuation Triple ART (N = 45)
100 80 80 60 60
Difference : 0.2%
(95% CI : to 10.2) 40 40 20 20
8.9
8.9
4.5
6.8
6.8
6.7
2.3
2.3
2.2
W24
W48
W24
W48
W24
W48
HIV RNA < 50 c/mL
HIV RNA > 50 c/mL
No virologic data
One confirmed virologic failure (DTG + 3TC arm)
HIV RNA (c/mL): W4: 21 ; W12: 48 ; W24: 375 confirmed at 235 ; W36 (on ABC/3TC + DRV/r): 264 ; W48: 85
At virologic failure (W24): no resistance mutation on RT or integrase ; therapeutic plasma concentration of DTG (3115 ng/mL)
One discontinuation for adverse event (DTG + 3TC arm): constipation grade 2
ASPIRE
Taiwo BO. Clin Infect Dis Dec 26 (ePub ahead of print)