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M. Lafaurie, M. Dolivo, M. Bentata, E. Carbonnel, M. Volstein, I. Bodokh, E. Allamagny, B. Loze, PowerPoint Presentation
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M. Lafaurie, M. Dolivo, M. Bentata, E. Carbonnel, M. Volstein, I. Bodokh, E. Allamagny, B. Loze, - PowerPoint PPT Presentation


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Polylactic acid vs polyacrylamide hydrogel for the treatment of facial lipoatrophy A randomized controlled trial ANRS 132 SMILE. M. Lafaurie, M. Dolivo, M. Bentata, E. Carbonnel, M. Volstein, I. Bodokh, E. Allamagny, B. Loze, I. Madelaine, R. Porcher, JM. Molina

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Polylactic acid vs polyacrylamide hydrogel for the treatment of facial lipoatrophy A randomized controlled trial ANRS 132 SMILE

M. Lafaurie, M. Dolivo, M. Bentata, E. Carbonnel,

M. Volstein, I. Bodokh, E. Allamagny, B. Loze,

I. Madelaine, R. Porcher, JM. Molina

and the ANRS 132 SMILE study group

anrs 132 study design and objectives
ANRS 132 : Study Design and Objectives

Randomized, partly blinded, open-label, non-inferiority study

Primary objective: demonstrate non-inferiority of Polyacrylamide gel vs. Polylactic acid injections in patient satisfaction at week 48 as assessed by a visual analogue scale score (VAS).

Primary analysis

Week 48

End of study

W 96

Injections

Week 0 4 8 12 16 20 24

148 patients randomized

Polylactic Acid (N=73)

  • ARV-experienced pts, 18 yrs
  • ART-induced lipoatrophy
  • No previous facial injection
  • CD4 cell count >100 c/mm3
  • No d4T
  • Normal coagulation tests

Polyacrylamide Gel (N=75)

Patients stratified by severity of lipoatrophy*

*as assessed by the baseline satisfaction visual analogue scale score

anrs 132 baseline characteristics
ANRS 132 : Baseline Characteristics

*lipoatrophy was clinically defined according to the severity scale from Carruthers et al.

non inferiority defined as 15 of mean satisfaction score at week 48

Polylactic acid

Polyacrylamide hydrogel

10

8

6

VAS

4

2

0

Week 48

Baseline

*Non inferiority defined as 15% of mean satisfaction score at Week 48

ANRS 132 : Efficacy Results at Week 48

Mean treatment difference (ITT) polyacrylamide gel - polylactic acid*

LOCF: + 0.4 (-0.4; 1.1); p = 0.0002

Observed cases: + 0.2 (-0.7; 1.0); p = 0.006

7.1

7.5

2.8

2.8

anrs 132 safety summary
ANRS 132 : Safety Summary

*assessed by a visual analogue scale

anrs 132 conclusions
ANRS 132 : Conclusions
  • Polyacrylamide hydrogel is non-inferior to polylactic acid for the treatment of facial lipoatrophy
  • Both treatments were associated with high patients satisfaction scores.
  • Polyacrylamide hydrogel is associated with more pain during injections.
  • Long-term inflammatory reactions at the injection site are a concern with polyacrylamide gel
  • Long-term follow-up is in progress
acknowledgments
Acknowledgments
  • All Patients participating in the study
  • ANRS 132 scientific committee: M. Bentata, E. De Kerviler, M. Dolivo, JM. Molina, R. Porcher, I. Madelaine, E. Carbonnel, G. Thoni, M. Lafaurie, Sanofi-Aventis, Procytech
  • ANRS clinical sites: St. Louis (Paris),St. Antoine (Paris), Bicêtre (KB), Avicenne (Bobigny), Brabois (Nancy), A. Paré (Boulogne), Bichat (Paris), P. Brousse (Villejuif), Cochin Tarnier (Paris), Bocage (Dijon), H. Mondor (Créteil), Cannes, Pessac (Toulouse), E. Herriot (Lyon).
  • DSMB: D. Costagliola, C. Lascoux, F. Rodenburg, C Lebbe
  • ANRS clinical research department: MJ. Comoy, S. Couffin, A. Métro.
  • Sanofi-Aventis (polylactic acid, Newfill®)and Procytech (polyacrylamid hydrogel, Eutrophill®) who provided the fillers