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Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE. ARIES Study: Switch ATV/r to ATV. Design. Randomisation* 1 : 1 Open-label. W84. Induction phase 36 weeks. Maintenance phase 48 weeks. HIV+≥ 18 years ARV-naïve HLA-B*5701-negative HIV-1 RNA ≥ 1000 c/mL Any CD4

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Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE

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Switch to atv containing regimen aries induma assure

  • Switch to ATV-containing regimen

    • - ARIES

    • - INDUMA

    • - ASSURE


Aries study switch atv r to atv

ARIES Study: Switch ATV/r to ATV

  • Design

Randomisation*

1 : 1

Open-label

W84

Induction phase

36 weeks

Maintenance phase

48 weeks

HIV+≥ 18 years

ARV-naïve

HLA-B*5701-negative

HIV-1 RNA ≥ 1000 c/mL

Any CD4

HBs Ag-negative

N = 515

N = 209

N = 210

* Randomisation if 2 consecutive HIV-1 RNA < 50 c/mL prior to W36 ; randomisation

stratified on baseline viral load (< 100.000 or ≥ 100.000 c/mL)

  • Endpoints

    • Primary: non inferiority in the proportion of patients with HIV-1 RNA < 50 c/mL at W48 of the maintenance phase (intent-to-treat, exposed analysis), lower limit of the 95% CI for the difference = -12%, 90% power

    • Secondary: treatment failure, CD4, fasting lipids, adverse events

Squires K, AIDS 2010;24:2019-27

ARIES


Aries study switch atv r to atv1

ARIES Study: Switch ATV/r to ATV

Baseline characteristics and patient disposition

Squires K, AIDS 2010;24:2019-27

ARIES


Aries study switch atv r to atv2

%

100

86

81

80

60

40

20

0

ITT-e (TLOVR)

ARIES Study: Switch ATV/r to ATV

Outcome at week 48 of the maintenance phase

HIV RNA < 50 c/mL

Other endpoints

ATV/r

ATV

  • HIV-1 RNA < 50 c/mL at W48 of the maintenance phase according to baseline plasma viral load

  • Per-protocol virologic failure(confirmed HIV-1 RNA > 400 c/mL after achieving < 400 c/mL)

    • ATV/r, N = 7

    • ATV, N = 1

    • No major PI-resistance mutations at failure

95% CI for the difference= -1.75 ; 12.48

Squires K, AIDS 2010;24:2019-27

ARIES


Aries study switch atv r to atv3

ARIES Study: Switch ATV/r to ATV

Grades 2 to 4 drug-related adverse events (frequency ≥ 3%)

and serious adverse events (intent-to-treat exposed)

Squires K, AIDS 2010;24:2019-27

ARIES


Aries study switch atv r to atv4

ARIES Study: Switch ATV/r to ATV

Fasting lipids (mg/dL), observed analysis

(intent-to-treat exposed)

Squires K, AIDS 2010;24:2019-27

ARIES


Aries study switch atv r to atv5

ARIES Study: Switch ATV/r to ATV

  • Conclusions

    • ATV + ABC/3TC

      • Is potent and well tolerated in patients who have achieved initial virologic suppression on a 36 weeks induction regimen of ATV/r + ABC/3TC

      • Represents a viable treatment simplification strategy

    • Limitations

      • Such a strategy is restricted to NRTI backbone such as ABC/3TC(TDF may lead to decrease in ATV levels and is therefore not recommended)

      • Unboosted ATV may offer less forgiveness than ritonavir-boosted ATV

Squires K, AIDS 2010;24:2019-27

ARIES


Aries study switch atv r to atv6

ARIES Study: Switch ATV/r to ATV

HIV RNA < 50 c/mL at W144, ITT

Drug-related AE between W36-W144

%

ATV/r

ATV

100

94

92

80

80

77

78

73

60

Emergence of resistance mutations

40

  • ATV, N = 2

  • ATV/r, N = 1

20

0

TLOVR

M/D = F

Observed

Squires K, IAS 2011, Abs. MOPE215

ARIES


Aries study switch atv r to atv7

ARIES Study: Switch ATV/r to ATV

Median values of fasting lipids, mg/dL

NCEP thresholds

ATV/r

ATV (from W36)

Total cholesterol

200 mg/dL

Triglycerides

200

150 mg/dL

186

183

181

182

160

LDL-C

163

153

152

160

130 mg/dL

151

120

127

123

121

104

HDL-C

98

98

99

80

88

85

40 mg/dL

40

51

49

46

45

39

37

0

0

36

144

0

36

144

0

36

144

0

36

144

Weeks

W0-W36: all patients received induction therapy with ABC/3TC + ATV/r

Squires K, IAS 2011, Abs. MOPE215

ARIES


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