1. Switch to ATV- or ATV/r-containing regimen
ARV-trial.com
Switch to ATV- or ATV/r-containing regimen
Switch to ATV/r-containing regimen
ATAZIP
Switch to ATV ± r-containing regimen
SWAN Study
SLOAT Study
Switch to ATV-containing regimen
ARIES Study
INDUMA Study
ASSURE Study 1

2. SWAN Study: switch PI+r to ATV+r
Design
Randomisation
2: 1
Open-label
W48
419 HIV+ patients
On stable PI-based regimen ≥ 3 months
(PI dosed at least bid and > 3 pills/day)
No history of failure on PI therapy
HIV RNA < 50 c/mL ≥ 3 months
CD4 > 50/mm3
N = 278
Switch to ATV+r qd*
+ continue other ARVs
N = 141
Continue previous PI regimen
+ other ARVs
* ATV 400 mg, or ATV/r 300/100 mg if TDF part of NRTI backbone
Objective
Non inferiority in the proportion of patients with virologic rebound at W48 (upper limit of the 95% CI for the difference = 12%, 90% power)
Virologic rebound: 2 consecutive HIV-1 RNA ≥ 50 c/mL on study, or last on-study HIV-1 RNA ≥ 50 c/mL followed by study discontinuation
SWAN
Gatell J, CID 2007;44:

3. SWAN Study: switch PI+r to ATV+r
ARV-trial.com
SWAN Study: switch PI+r to ATV+r
Baseline characteristics and patient disposition
ATV+r,
N = 278
Comparator PI, N = 141
Median age, years 40 41
Female
16%
21%
History of AIDS diagnosis
27%
31%
Hepatitis B and/or C co-infection
32%
Duration of prior PI treatment, mean years
3.4
3.3
HIV-1 RNA at randomisation (baseline), median log10c/mL
1.69
CD4 cell count at baseline, median/mm3
490
489
Discontinuation before W48, n (%)
40 (14%)
27 (19%)
For adverse event 17 8
For lack of efficacy 1 2
PI use at screening was LPV/r: 37%, NFV: 33%, IDV/r: 10%, IDV: 8%,
SQV/r: 6%, SQV: 3%
TDF was part of the ARV regimen in 37 patients (9%) [26 in the ATV group]
SWAN
Gatell J, CID 2007;44:

4. SWAN Study: switch PI+r to ATV+r
Virologic rebound (HIV-1 RNA ≥ 50 c/mL)
Treatment
failure 5 10 15 35 40 30 25 20
p = 0,004
p = 0,53
p < 0,001 7% 8% 5%
16%
11%
22%
21%
34%
19/278
22/141
12/150
8/76
7/128
14/65
59/278
48/141
Difference estimate
(95% CI)
-8.8 (-14.8 ; -2.7)
-2.5 (-10.4 ; 5.3)
-16.1 (-25.4 ; -6.8)
-12.8 (-21.7 ; -4.0)
ATV group
Comparator PI group
Patients on PI/r
at screening
All patients
Patients on unboosted
PI at screening %
SWAN
Gatell J, CID 2007;44:

5. SWAN Study: switch PI+r to ATV+r20 40 60 80
100 12
Baseline 36 24 48
Weeks
Patients not experiencing virologic rebound,%
Hazard Ratio estimate (95% CI): 0.42 ( ) ; p = 0.007
Patients not experiencing treatment failure,%
Hazard Ratio estimate (95% CI): 0.59 ( ) ; p = 0.008
ATV group
Comparator PI group
278
141
254
231
239
143
121
101
110 74
258
240
122
ATV group
Comparator PI group
SWAN
Gatell J, CID 2007;44:

6. SWAN Study: switch PI+r to ATV+r
Mean changes from baseline in lipid parameters at W48
ATV group
Comparator PI group TC
HDL-C
Fasting TG
Non-HDL-C
Mean mg/dL at baseline
Mean mg/dL at Week 48
123
108
135
133
212
181
220
216 50 51 49
203
137
201
215
162
132
171
168
Fasting LDL-C
-40
-30
-10 10
-20
p = 0.18
p < 0.001
p = 0.62
-12%
-5%
-3%
-15%
-1%
-33%
-18% 9%
HDL-C,high density lipoprotein cholesterol ; LDL-C, low-density lipoprotein cholesterol ; PI, protease inhibitor ; TC, total cholesterol
SWAN
Gatell J, CID 2007;44:

7. SWAN Study: switch PI+r to ATV+r
Adverse events by W48
ATV group
Comparator PI
Death 5
Serious adverse event
27 (10%)
9 (6%)
Discontinuation because of adverse event
17 (6%)
8 (6%)
Scleral icterus
8 (3%)
Jaundice
7 (3%)
Abdominal pain
6 (2%)
2 (2%)
Grade 3-4 ALT elevation
12 (4%)
Grade 3-4 AST elevation
4 (3%)
Grade 3-4 total bilirubin elevation
116 (43%)
AST and ALT elevations were more frequent in patients with hepatitis co-infection
SWAN
Gatell J, CID 2007;44:

8. SWAN Study: switch PI+r to ATV+r
Conclusions
Switching to a simplified PI-based regimen containing ATV provided better maintenance of virologic suppression with lower rates of virologic rebound and treatment failure than those observed with continued, unmodified therapy
Safety and tolerability were similar in both groups
But lipid parameters improved in the ATV group
Hyperbilirubinemia was frequent on ATV
SWAN
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