Retreatment with Injectable Poly-l-Lactic Acid for HIV-Associated Facial Lipoatrophy: 24-Month Extension of the Blue Pacific Study

Facial lipoatrophy occurs in HIV-positive patients taking highly active antiretroviral therapy and during natural aging. Injectable poly-l-lactic acid (PLLA) is a device approved internationally for restoration and correction of the signs of HIV-associated facial lipoatrophy. To evaluate the long-term safety, duration of effect, and satisfaction with serial injections of PLLA for HIV-associated facial lipoatrophy. In this single-site, open-label, retreatment study, 65 HIV-positive patients were treated with injectable PLLA every 5 weeks (until optimal recorrection). Presenting degree of lipoatrophy based on the James scale (1=mild, 4=severe) was reviewed. Skin thickness was measured at fixed points with calipers. Patients completed a post-retreatment satisfaction questionnaire. Nearly 10% of patients had persistent correction > 36 months, based on patient report. Approximately 50% required three or fewer retreatments to maintain satisfactory correction (determined by patient and physician). Milder lipoatrophy on initial presentation required fewer retreatments and had more sustained correction. Time to first retreatment varied according to James scale score: 1 (21.4 months) and 4 (13.0 months). The mean patient satisfaction score was 4.9 (1=dissatisfied, 5=very satisfied) at study end. No serious adverse events were reported. Injectable PLLA is a safe and effective long-term treatment option for HIV-associated lipoatrophy. Dr. Mest is a consultant for Dermik Aesthetics, a division of sanofi-aventis U.S. LLC, and Dr. Humble is a consultant for Dermik Laboratories, a business of sanofi-aventis U.S. LLC. Study materials were provided by Dermik Laboratories.