switch studies in virologically suppressed patients n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Switch studies in virologically suppressed patients PowerPoint Presentation
Download Presentation
Switch studies in virologically suppressed patients

Loading in 2 Seconds...

play fullscreen
1 / 7

Switch studies in virologically suppressed patients - PowerPoint PPT Presentation


  • 136 Views
  • Uploaded on

Switch studies in virologically suppressed patients. Switch to TDF/FTC/EFV AI266-073 Switch to FTC + ddI + EFV ALIZE Switch to ATV/r-containing regimen ATAZIP Switch to ATV ± r-containing regimen SWAN SLOAT Switch to ATV-containing regimen ARIES INDUMA Switch to ATV/r monotherapy

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

Switch studies in virologically suppressed patients


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
switch studies in virologically suppressed patients
Switch studies in virologically suppressed patients

Switch to TDF/FTC/EFV

AI266-073

Switch to FTC + ddI + EFV

ALIZE

Switch to ATV/r-containing regimen

ATAZIP

Switch to ATV±r-containing regimen

SWAN

SLOAT

Switch to ATV-containing regimen

ARIES

INDUMA

Switch to ATV/r monotherapy

ATARITMO

Swedish Study

ACTG A5201

OREY

Synopsis

  • Switch to LPV/r monotherapy
    • Pilot LPV/r
    • M03-613
    • American Study
    • KalMo
    • OK
    • OK04
    • KALESOLO
    • MOST
    • HIV-NAT 077
  • Switch to DRV/r monotherapy
    • MONOI
    • MONET
  • Switch to RAL-containing regimen
    • Canadian Study
    • CHEER
    • Montreal Study
    • EASIER
    • SWITCHMRK
    • SPIRAL
alize study switch pi r to ftc ddi efv
ALIZE Study: Switch PI+r to FTC + ddI + EFV
  • Design

Randomisation

1 : 1

Open-label

W48

N = 177

389 HIV+ adults

ARV with PI±r + 2 NRTIs

HIV-1 RNA < 400 c/mL > 6 months

CD4 cell count ≥ 100/mm3

NNRTI-naïve

N = 178

  • Objective
    • Non inferiority in the proportion of patients with HIV-1 RNA < 400 c/mL at W48 (Intent-to-treat analysis, missing = failure) ; upper limit of the 95% CI for the difference = 15%, 80% power

Molina JM, JID 2005;191:830-9

ALIZE

alize study switch pi r to ftc ddi efv1
ALIZE Study: Switch PI+r to FTC + ddI + EFV

Baseline characteristics and patient disposition

Molina JM, JID 2005;191:830-9

ALIZE

alize study switch pi r to ftc ddi efv2

ITT,

M = F

On Treatment,M = F

Kaplan-Meier(ITT)

%

96

93.1

100

90.5

87.6

87

79

80

60

40

20

0

HIV-1 RNA

< 200 c/mL

HIV-1 RNA

< 200 c/mL

HIV-1 RNA

< 50 c/mL

Non inferiority

Upper bound of

the 95% CI for

the ≠: 2,6%

Upper bound of

the 95% CI for

the ≠: 1.2%

p < 0.05

log rank test

ALIZE Study: Switch PI+r to FTC + ddI + EFV

Outcome at Week 48

Virologic response

Continuation PI

FTC + ddI + EFV

M= F: missing= failure

  • Patients who had received prior suboptimal ARV therapy with mono- or dual-NRTIs alone were not a higher risk of virologic failure (10% vs 11%)

Molina JM, JID 2005;191:830-9

ALIZE

alize study switch pi r to ftc ddi efv3
ALIZE Study: Switch PI+r to FTC + ddI + EFV

CD4 response, resistance and safety

  • No differences in median CD4 cell counts over time between groups
  • 13/14 virologic failures had a genotype (5 in the FTC + ddI + EFV group,8 in the PI group)
    • FTC + ddI + EFV: R to EFV (K103N, N = 4, L100I, N = 2) + FTC (M184V) = 5/5 ; L74 V in 1/5
    • PI group: major PI resistance mutation = 3/8, M184V = 5/8
  • Trend towards a higher overall incidence of grade 2 to 4 adverse events in the FTC + ddI + EFV group (48% vs 38%, p = 0.06)
    • Related to neurosensorial reactions in first 4 weeks
    • And to higher increases in aminotransferase levels
  • Discontinuation for adverse events was similar in both groups: 10% vs 9%, for PI and FTC + ddI + EFV group, respectively
  • Lipoatrophy increased in the PI group (46% at baseline vs 60% at W48) and remained stable in the FTC + ddI + EFV group (43% vs 42%), p < 0.0001
  • Full adherence (100% of the pills taken during the 4 days before all visits) through W48 was 63% vs 82%, respectively (p = 0.0002)

Molina JM, JID 2005;191:830-9

ALIZE

alize study switch pi r to ftc ddi efv4

Total cholesterol

35

30

25

20

15

10

5

0

-5

-10

-15

-20

-25

Weeks

0

4

8

12

16

20

24

28

32

36

40

44

48

171

160

163

164

159

155

164

PI

173

168

166

171

166

166

169

FTC + ddI + EFV

ALIZE Study: Switch PI+r to FTC + ddI + EFV

Median change from baseline in fasting lipids (mg/dL)

Continuation PI

FTC + ddI + EFV

Triglycerides

HDL cholesterol

60

20

50

40

15

30

20

10

10

0

5

-10

-20

0

-30

-40

-5

-50

-60

-10

Weeks

Weeks

0

4

8

12

16

20

24

28

32

36

40

44

48

0

4

8

12

16

20

24

28

32

36

40

44

48

171

160

164

163

158

154

163

PI

166

153

157

158

152

143

153

PI

173

168

166

171

167

165

168

FTC + ddI + EFV

171

162

157

164

162

160

159

FTC + ddI + EFV

Molina JM, JID 2005;191:830-9

ALIZE

alize study switch pi r to ftc ddi efv5
ALIZE Study: Switch PI+r to FTC + ddI + EFV
  • Conclusions
    • Switching a PI-based regimen, in patients with virologic suppression, to a convenient once-daily combination of FTC + ddI + EFV is associated with
      • Sustained virologic suppression
      • Some adverse events, mainly neurosensorial and hepatic, usually not treatment-limiting
      • Improvement in HDL cholesterol
      • No worsening of lipoatrophy

Molina JM, JID 2005;191:830-9

ALIZE