1. NRTI-sparing SPARTAN PROGRESS RADAR NEAT001/ANRS 143 A4001078 VEMAN
ARV-trial.com
NRTI-sparing
SPARTAN
PROGRESS
RADAR
NEAT001/ANRS 143 A
VEMAN
MODERN 1

2. RADAR Study: DRV/r + RAL vs DRV/r + TDF/FTC
118
Design
Randomisation
1 : 1
Open-label
W96
N = 42
Age ≥ 18 years
HIV+
Antiretroviral naive
HIV-1 RNA ≥ c/mL
CD4 ≥ 100/mm3
No resistance to TDF, FTC or DRV
DRV/r 800/100 qd + RAL 400 bid
DRV/r + TDF/FTC
N = 43
Objective
Primary endpoint: time to loss of virologic response until W24 (ITT, TLOVR)
Definition of failure: the earliest of any of the following events: death, permanent discontinuation of the study drug, loss to follow-up, or plasma HIV-1 RNA concentrations > 48 copies/ml obtained at 2 consecutive visits or one value > 48 copies/ml followed by permanent discontinuation of the study drug or loss to follow-up
RADAR
Bedimo R. PLOS One 2014;9:e106221

3. RADAR Study: DRV/r + RAL vs DRV/r + TDF/FTC
Baseline characteristics (median), and disposition
DRV/r + RAL
N = 40
DRV/r + TDF/FTC
N = 43
Age, years 44 39
Female
10% 5%
CD4/mm3
249
201
HIV RNA, log10 copies/mL
4.69
4.92
Discontinuation by W48
N = 9
N = 6
Virologic efficacy
DRV/r + RAL
DRV/r + TDF/FTC
HIV RNA < 48 c/mL at W24 (ITT, TLOVR)
75%
76.7%
Mean time to loss of virologic response (ITT, TLOVR)
36.3 weeks
42.1 weeks
HIV RNA < 48 c/mL at W48 (ITT, TLOVR)
60%
83.7%
≠ : % (95% CI : to – 5.0) ; p = 0.016
HIV RNA < 48 c/mL at W48 (ITT, snapshot)
62.5%
Resistance testing: no treatment-emergent resistance-associated mutations
RADAR
Bedimo R. PLOS One 2014;9:e106221

4. RADAR Study: DRV/r + RAL vs DRV/r + TDF/FTC
Lipid parameters, renal function, body fat and bone mineral density
Mean changes from baseline (95% CI)
DRV/r + RAL
N = 40
DRV/r + TDF/FTC
N = 43 p
Total cholesterol, mg/dL
+ 23.3
+ 6.5
0.003
LDL-cholesterol, mg/dL
+ 11.2
+ 3.3 NS
HDL-cholesterol, mg/dL
+ 4.8
+ 7.2
Triglycerides, mg/dL
+ 21.2
- 38.1
Total cholesterol:HDL cholesterol ratio
- 0.25
- 0.71
eGFR (CKD-EPI formula), ml/min
- 4.4
- 7.9
DXA analyses
Subtotal BMD, g/cm2
Total BMD, g/cm2
Total fat, kg
Total lean body mass, kg
+ 9.2
+ 11.3
+ 3.13
+ 1.48
- 7
- 6.9
+ 1.8
+ 0.6
0.002
0.013
0.084
Grade 3 or higher clinical or laboratory adverse event: 5 in the RAL arm vs 2 in the TDF/FTC arm
RADAR
Bedimo R. PLOS One 2014;9:e106221

5. RADAR Study: DRV/r + RAL vs DRV/r + TDF/FTC
Conclusion
The NRTI-sparing regimen RAL+ DRV/r did not achieve similar week 48 virologic efficacy compared with TDF/FTC + DRV/r, but was better with regard to markers of bone health
The two regimens achieved comparable immunologic response
Patients in the TDF/FTC arm had smaller increases in total cholesterol
Limitations
Small sample size
Unpowered to establish non-inferiority
AEs self-reported, open-label unblinded design
No site-specific BMD evaluation
RADAR
Bedimo R. PLOS One 2014;9:e106221