Patient Reported Outcomes from HIV Facial Lipoatrophy Treatment With a Volumizing Hyaluronic Acid Filler: A Prospective, Open-Label, Phase I and II Study.

[BACKGROUND] Human immunodeficiency virus (HIV) facial lipoatrophy (FLA) is associated with the use of highly active antiretroviral therapy (HAART) and HIV disease. HIV FLA is primarily characterized by midface (cheeks and temples) volume loss, resulting in a "sunken" and aged appearance. Filler agents for treatment of HIV FLA can provide midface volumization and improve quality-of-life (QOL). A 20 mg/ml hyaluronic acid (HA) filler (Juvéderm Voluma® XC, Allergan plc, Irvine, CA) may provide an immediate, natural appearing facial enhancement outcome in one treatment. We hypothesized that this HA filler for treatment of HIV FLA is safe and efficacious and may help improve patients' QOL.<br/>

[OBJECTIVE] To provide patient reported outcomes from HA filler for treatment of HIV FLA and suggest recommendations on use of validated QOL outcome measures to assess patient concerns specific to HIV FLA.<br/>

[METHODS] This was a prospective, open-label, phase I and II study to evaluate patient reported outcomes, in addition to safety and efficacy, of this HA filler for treatment of HIV FLA in 20 subjects at the Sacramento Veterans Affairs Medical Center, Mather, CA (ClinicalTrials.gov NCT02342223). Outcome measures include the Dermatology Life Quality Index (DLQI) and a subject satisfaction questionnaire (SSQ).<br/>

[RESULTS] Nineteen subjects completed the 12-month follow-up. There was no significant improvement of DLQI score. Subject comments revealed high degree of satisfaction and there were no negative comments on the SSQ.<br/>

[CONCLUSIONS] In this study, we report that all subjects that completed this study were satisfied and had subjective improvement of their QOL post-treatment. We recommend against use of DLQI in the future as it may not fully encompass the emotional and mental health aspects that may be affected from HIV FLA. We recommend use of the Facial Appearance Inventory (FAI) and FACE-Q in future studies for HA filler treatment of HIV FLA. <br /><br /> <em>J Drugs Dermatol.</em> 2016;15(9):1064-1069.