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