Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA.
BACKGROUND
In the absence of currently available therapy to manage facial lipoatrophy, 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-Fill) in HIV-infected patients with severe facial lipoatrophy. Patients received four sets of injection at day 0 and then every 2 weeks for 6 weeks. Patients were evaluated by clinical examination, facial ultrasonography, and photography at screening and at weeks 6, 24, 48, 72, and 96.


RESULTS
Fifty patients were enrolled. At entry, the median facial fat thickness was equal to zero (range, 0.0-2.1 mm). The median total cutaneous thickness (TCT) increased significantly from baseline : +5.1 mm (range, 2.2-8.6 mm) at week 6, +6.4 mm (range, 3.1-9.1 mm) at week 24, +7.2 mm (range, 4.2-9.6 mm) at week 48, +7.2 mm (range, 3.5-9.6 mm) at week 72 and +6.8 mm (range, 3.9-10.1 mm) at week 96 (P < 0.001). The proportion of patients with TCT > 10 mm was observed in 19% at week 6, 41% at week 24, 61% at week 48, 52% at week 72 and 43% at week 96. In 22 (44%) patients, palpable but non-visible subcutaneous micronodules were observed with a spontaneous resolution in six patients at week 96.


CONCLUSIONS
The benefit of PLA for the correction of the facial lipoatrophy in HIV-infected patients was clearly demonstrated, with an evident aesthetic and quality of life improvement. The efficacy, safety profile, and the simplicity of the injection schedule of PLA make this filling material a potentially attractive treatment.
Departement des Maladies Infectieuses et Tropicales, Hôpital Pitié-Salpêtrière, INSERM 0214 Université Pierre et Marie CURIE, Paris, France.
Marc-Antoine
MA
Valantin
Camille
C
Aubron-Olivier
Jade
J
Ghosn
Elisabeth
E
Laglenne
Michelle
M
Pauchard
Hélène
H
Schoen
Raymond
R
Bousquet
Philippe
P
Katz
Dominique
D
Costagliola
Christine
C
Katlama
D000273:Adipose Tissue / Q000473:pathology; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects; D004343:Drug Implants; D005145:Face / Q000000981:diagnostic imaging; D005148:Facial Dermatoses / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000188:drug therapy*; D006801:Humans; D007267:Injections; D019344:Lactic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011091:Polyesters; D011108:Polymers / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D014463:Ultrasonography
D001672:Biocompatible Materials; D004343:Drug Implants; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)