Patient Reported Outcomes from HIV Facial Lipoatrophy Treatment With a Volumizing Hyaluronic Acid Filler: A Prospective, Open-Label, Phase I and II Study
September 2016 | Volume 15 | Issue 9 | Original Article | 1064 | Copyright © 2016
Derek Ho BSa,b and Jared Jagdeo MD MSa,b,c
aDermatology Service, Sacramento VA Medical Center, Mather, CA
bDepartment of Dermatology, University of California Davis, Sacramento, CA
cDepartment of Dermatology, State University of New York Downstate Medical Center, Brooklyn, NY
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.
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.
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).
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.
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.
J Drugs Dermatol. 2016;15(9):1064-1069.
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Human immunodeficiency virus (HIV) facial lipoatrophy (FLA) is associated with the use of highly active antiretroviral therapy (HAART) and HIV disease.1 HIV FLA is primarily characterized by midface (cheeks and temples) volume loss, resulting in a “sunken” and aged appearance. The prevalence of HIV FLA is significant and may exceed 50% among the HIV population.2 Although new HAART medications are associated with less severe HIV FLA, first generation HAART medications are still currently being used in geographic areas with limited resources. Additionally, the cumulative dose of HAART medications is a risk factor for HIV FLA, and this may be a significant concern as patients are now living longer with HIV on HAART.
HIV FLA is a major stigma for HIV patients as they are twice as likely to feel recognizable as HIV-positive from their physical appearance.3,4 HIV FLA may negatively affect patients’ adherence to HAART and psychological health.5-8 The impact to patients’ quality-of-life (QOL), such as with friendship and social support system, may result in depression and personal identity changes.9,10 Filler agents for treatment of HIV FLA can provide midface volumization and improve many categories of QOL, including health perception, mental health, social function, and emotional status.11,12
In 2004 and 2006, the FDA approved poly-L-lactic acid (PLLA, Sculptra®, Galderma, Fort Worth, TX) and calcium hydroxylapatite (CaHA, Radiesse®, Merz Aesthetics, Raleigh, NC), respectively, for treatment of HIV FLA. However, PLLA and CaHA each have their own limitations, such as delayed results, a need for frequent retreatment, risk of nodule and granuloma formation, and filler composition that may not be optimal for midface volumization.13 In addition, PLLA and CaHA is non-reversible in an instance of an adverse event. There is an unmet need for treatment of HIV FLA that may improve patients’ QOL with immediate, durable, and natural looking results that is