Post on 13-Dec-2015
Switch to ATV ± r-containing regimen
SWAN Study SLOAT Study
SLOAT Study: switch LPV/r to ATV+r
Design
Objective Non inferiority in the proportion of patients with virologic rebound at W48
(upper limit of the 95% CI for the difference = 90%, 90% power) Virologic rebound: HIV-1 RNA > 50 c/mL
Switch to ATV+r qd*+ continue NRTIs
Continue LPV/r+ NRTIs
* ATV 400 mg (N = 49), or ATV/r 300/100 mg if TDF part of NRTI backbone (N = 53)
RandomisationOpen-label
RandomisationOpen-label
224 HIV+ patientsOn LPV/r + 2 NRTIs ≥ 3 monthsHIV RNA < 50 c/mL ≥ 24 weeks
224 HIV+ patientsOn LPV/r + 2 NRTIs ≥ 3 monthsHIV RNA < 50 c/mL ≥ 24 weeks
N = 87
N = 102
W48W48
Soriano V, JAC 2008;61:200-5SLOATSLOAT
SLOAT Study: switch LPV/r to ATV+r
LPV/rN = 87
ATV+rN = 102
Median age, years 40 42
Female 41% 18%
Median CD4 cell count/mm3 403 548
Median exposure to prior ARV, months* 38 57
Chronic Hepatitis C 45% 36%
Chronic hepatitis B 3% 3%
Discontinuation before W48, n 1 (lost to follow-up) 2 (jaundice)
Baseline characteristics and patient disposition
* Nearly half of the patients had been exposed to other PIs, before LPV/r, and failure on prior PIs had occurred in two-thirds of these PI-experienced patients
Soriano V, JAC 2008;61:200-5SLOATSLOAT
SLOAT Study: switch LPV/r to ATV+r
Virologic failure
11.710.3
0
5
10
15
20
25
30
12/1029/87
%
Results: W48 outcome Resistance mutations at virologic
failure– LPV/r: 1/9– ATV: 2/5
– ATV/r: 3/7
Median ATV Ctrough *
– ATV/r: 0.822 mg/L
– ATV: 0.234 mg/L
Median CD4 increase between baseline and W48– LPV/r: 46/mm3
– ATV+r: 42/mm3
Soriano V, JAC 2008;61:200-5SLOATSLOAT
Switch to ATV±rContinue on LPV/r
* Effective minimal Ctrough = 0.15 mg/L
SLOAT Study: switch LPV/r to ATV+r
Median changes (mg/dL) in fasting metabolic parameters from baseline up to Week 48
LPV/rN = 87
ATV totalN = 102 p ATV 400
N = 49 pATV/r
300/100N = 53
p
Triglycerides -5 -80<
0.001-96
< 0.001
-38 0.022
Total cholesterol -0.5 -19<
0.001-27
< 0.001
-12 NS
HDL cholesterol -0.5 +2 NS -1 NS +4 NS
LDL cholesterol +1 +1 NS -4 NS +2 NS
Glucose +6 -1 NS -2 NS +1 NS
Proportion of patients with LDL cholesterol levels within NCEP categoriesLDL 130-159 mg/dL 21% 7%
LDL 160-189 mg/dL 9% 3%
LDL ≥ 190 mg/dL 5% 1%
Metabolic parameters
Soriano V, JAC 2008;61:200-5SLOATSLOAT
Use of lipid-lowering agents was more frequent in the LPV/r group: 17% vs 5% (p = 0.006)
SLOAT Study: switch LPV/r to ATV+r
Conclusion– For patients with undetectable viraemia on a stable
LPV/r-based regimen, replacement of LPV/r by ATV+r may provide:
• An overall reduction in fasting cholesterol and triglycerides
• No increased risk of virologic failure
Soriano V, JAC 2008;61:200-5SLOATSLOAT