Retreatment with injectable poly-l-lactic acid for HIV-associated facial lipoatrophy: 24-month extension of the Blue Pacific study.

BACKGROUND: 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. OBJECTIVE: To evaluate the long-term safety, duration of effect, and satisfaction with serial injections of PLLA for HIV-associated facial lipoatrophy. METHODS AND MATERIALS: 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. RESULTS: 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. CONCLUSION: Injectable PLLA is a safe and effective long-term treatment option for HIV-associated lipoatrophy.

Safety and efficacy of poly-L-lactic acid injections in persons with HIV-associated lipoatrophy: the US experience.

BACKGROUND: With the introduction of highly active antiretroviral therapy (HAART), HIV/AIDS has become a more chronic disease. This increase in survival, however, has been accompanied by the occurrence of metabolic and morphologic changes known collectively as HIV-associated lipodystrophy. OBJECTIVE: The objective was to evaluate the quantifiable improvement in facial wasting (lipoatrophy) after serial injections of poly-L-lactic acid (PLLA) as well as the long-term safety and durability of this material. METHODS AND MATERIALS: A single-site, open-label study in which patients received up to six treatment sessions of injectable PLLA. Patients were followed for 12 months after treatment. Patients were evaluated for increase in total cutaneous thickness by skin calipers. Serial photographs and patient satisfaction and patient well-being questionnaires were undertaken throughout the study period. RESULTS: Patients at the end of treatment exhibited a mean increase in skin thickness of 65.1% compared with baseline values. This correction was maintained throughout the 12-month follow-up period (68.8% at 6 months and 73% at 12 months). On a one to five scale, patient satisfaction was 4.5 at the end of treatment and increased to 4.8 at 12-month follow-up. No serious adverse events were reported. CONCLUSION: PLLA is a safe and well-tolerated treatment option for HIV-associated lipoatrophy.