1. Intensification with INSTI
ARV-trial.com
Intensification with INSTI
REALITY 1

2. Adults, adolescents and children > 5 years
ARV-trial.com
REALITY Study: raltegravir-intensified quadruple therapy in first-line antiretroviral therapy
Design
Randomisation
1 : 1
Open label
W48
N = 902
2 NRTI + NNRTI + 12 weeks of RAL
Adults, adolescents and children > 5 years
ARV-naïve
CD4 < 100/mm3
N = 903
2 NRTI + NNRTI
Two other factorial randomisations: 12 weeks enhanced prophylaxis, 12 weeks supplementary food
Objective
Primary endpoint: 24-week mortality
REALITY
Kityo C. AIDS 2016, Durban, Abs. FRAB0102LB 2

3. Baseline characteristics
ARV-trial.com
REALITY Study: raltegravir-intensified quadruple therapy in first-line antiretroviral therapy
Baseline characteristics
Additional RAL, N = 902
Standard ART, N = 903
Median age, years
5-17 years, % 36 4
Female, % 47
WHO stage 1 or 2, % 46 48
CD4 cell count (/mm3), median
CD4 < 25/mm3, % 38 37
HIV RNA (log10 c/mL), median
HIV RNA > c/mL, % 72
EFV, % 89 90
TDF/FTC backbone, % 78 80
REALITY
Kityo C. AIDS 2016, Durban, Abs. FRAB0102LB 3

4. HIV RNA < 50 copies/mL (95% CI)
REALITY Study: raltegravir-intensified quadruple therapy in first-line antiretroviral therapy
Mortality
HIV RNA < 50 copies/mL (95% CI)
902
825
801
786
775
766
657
903
830
789
776
760
669
10.2%
13.0%
10.9%
12.4% 5 10 15 20
N at risk 8 16 24 32 40 48
Weeks 60 80
100 4 12
14.5%
54.6%
76.0%
79.5%
42.8%
74.1%
77.2%
82.9% %
Mean change in CD4/mm3 at W48:
+ 163 vs (p = 0.04)
W24: HR =1.09 (95% CI: ) ; p = 0.54
Additional RAL
Standard ART
REALITY
Kityo C. AIDS 2016, Durban, Abs. FRAB0102LB

5. Secondary/other outcomes (HR, 95% CI)
REALITY Study: raltegravir-intensified quadruple therapy in first-line antiretroviral therapy
Secondary/other outcomes (HR, 95% CI)
RAL better
Standard ART better
WHO 4 or death
p = 0.72
WHO 3 or 4 or death
p = 0.43
New TB disease
p = 0.82
New cryptococcal disease
p = 0.48
New candida disease
p = 0.85
Presumptive severe bacterial infection
p = 0.28
SAE
p = 0.90
Grade 4 AE
p = 0.28
Grade 3 or 4 AE
p = 0.75
Grade 4 AE in first 12 weeks
p = 0.86
Grade 4 AE related to ART
p = 0.38
Grade 4 AE def/prob related to ART
p = 0.03
AE leading to ART modification
p = 0.51
0.5
0.7
1.0
1.5
2.0
REALITY
Kityo C. AIDS 2016, Durban, Abs. FRAB0102LB

6. ARV-trial.com
REALITY Study: raltegravir-intensified quadruple therapy in first-line antiretroviral therapy
Conclusion
Standard triple ART (FTC/TDF + EFV) intensified with raltegravir for 12 weeks
Was well tolerated
Resulted in faster HIV RNA reduction through 24 weeks, and higher increase in CD4 at 48 weeks
But did not reduce mortality or WHO 3/4 events through either week 24 or 48
REALITY
Kityo C. AIDS 2016, Durban, Abs. FRAB0102LB 6