AEGiS-10CROI: Polylactic Acid Implants (New-Filla) in the Correction of Facial Lipoatrophy in HIV-infected Patients (VEGA Study): Results at 72 Weeks.

10th Conference on Retroviruses and Opportunistic Infections

Boston, MA USA - February 10 -14, 2003

Polylactic Acid Implants (New-Filla) in the Correction of Facial Lipoatrophy in HIV-infected Patients (VEGA Study): Results at 72 Weeks.

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 719
Valantin MA, Aubron-Olivier C, Ghosn J, Laglenne E, Pauchard M, Schoen H, Katz P, Costagliola D, Katlama C; GH Pitie-Salpetriere, Paris, France

BACKGROUND: There is as yet no proven strategy to manage facial lipoatrophy. In the absence of currently available therapy, strategies used to compensate for facial fat loss warrant clinical evaluation.

METHODS: The goal of this open-label, single-arm, pilot study was to evaluate the efficacy and safety of facial injections of poly-L-lactic acid (PLA) (New-Filla) in HIV-infected patients (pts) with severe facial lipoatrophy over 96 wks (2 yrs). Pts received 4 sets of injection at day 0 and then every 2 wks for 6 wks. Pts were evaluated by clinical examination, facial ultrasonography, and photography at screening and at wks 6, 24, 48, 72, and 96.

RESULTS: Fifty (50) pts were enrolled into the study between June 2000 and February 2001. All pts had severe facial lipoatrophy with, at entry, a median facial fat thickness equal to zero (range 0.0-2.1). The median total cutaneous thickness (TCT) increased significantly from baseline: +5.1 mm (2.2-8.6) at wk 6, +6.4 mm (3.1-9.1) at wk 24, +7.2 mm (4.2-9.6) at wk 48 and +7.1 mm (3.5-9.6) at wk 72 (p < 0.001). The proportion of pts with a TCT of 10 mm or greater was observed in 19% at wk 6; 41% at wk 24; 61% at wk 48; and 48% at wk 72. Results at wk 96 will be presented. No serious adverse events were observed. Minimal and localized edema at the injection site was reported for most pts, which spontaneously resolved within 24-48 hrs.

CONCLUSIONS: The benefit of PLA for the correction of the facial lipoatrophy in HIV-infected pts was clearly demonstrated in this study, with an evident esthetic improvement and improved pt quality of life. The efficacy, safety profile, and the simplicity of the injection schedule of PLA also make this filling material a potentially attractive treatment.

Keywords: AEGIS, Lactic Acid, Lipodystrophy, Polymers, Drug Implants, HIV Infections, poly(lactic acid), Prostheses and Implants, HIV Seropositivity, Anti-HIV Agents, Face, Biocompatible Materials, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Human

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Copyright © 2003 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.