Patients with HIV-associated facial lipoatrophy who received treatment with hyaluronic acid filler achieved significant improvement in facial volume up to 1 year, with no permanent adverse events, according to a new study.
Healio reports that researchers at the Sacramento Veterans Affairs Medical Centre, Mather, California, University of California – Davis, Sacramento and the State University of New York Downstate Medical Centre, Brooklyn conducted an open-label study of 20 men (mean age, 57 years) with HIV-associated facial lipoatrophy (FLA) who received one hyaluronic acid treatment with an optional touch-up at the Sacramento Veterans Medical Centre. The patients had a Carruthers Lipoatrophy Severity Scale (CLSS) grade of 2 or greater and had not been previously treated for FLA during the prior year.
Treatment and follow-up occurred between 15 March, 2015, and 17 May, 2016. Treatment included midface (cheeks and temples) volumisation using the “smile and fill,” fanning and depot technique, followed by an optional touch-up at 2-week follow-up.
Nineteen patients completed the study, and the mean volume of hyaluronic acid used in initial treatments were 4.5 mL for grade 2 FLA, 8 mL for grade 3 FLA and 18 mL for grade 4 FLA, with 1 mL equaling 1 syringe of hyaluronic acid filler. Fourteen patients received touch-up treatments. Mean total volume of hyaluronic acid used for all treatments was 6.1 mL for grade 2 FLA, 9.3 mL for grade 3 FLA and 26 mL for grade 4 FLA.
There were no reports of permanent treatment-related adverse events, with common transient adverse events lasting less than 21 days including ecchymosis, oedema, tenderness and pain.
The patients achieved a significant decrease in CLSS, with all patients achieving CLSS grade 1 after optional touchup at 2-week follow-up visit. All patients maintained CLSS grade 1 at follow-ups.
All patients were rated much improved using the Global Aesthetic Improvement Scale at 2-week follow-up, with patients rated at very much improved at 12 months.
“This study reports excellent safety and efficacy and supports use of this (hyaluronic acid) filler for treatment of HIV FLA, with durable results at 12 months,” the researchers concluded. “Future multicenter, randomised clinical trials with blinded independent investigators may confirm its long-term safety, efficacy and durability. Additional research may ensure widespread adoption by dermatologists and patients.”
Importance: Facial lipoatrophy (FLA) is associated with human immunodeficiency virus (HIV) disease and the use of highly active antiretroviral therapy. The condition is primarily characterized by facial volume loss that affects the contours of the cheeks, temples, and orbits and may negatively affect patients’ adherence to highly active antiretroviral therapy, psychological health, and quality of life. A single treatment of hyaluronic acid (HA) filler, 20 mg/mL, may provide an immediate, natural-appearing facial enhancement outcome.
Objective: To evaluate the safety and efficacy of an HA filler for treatment of HIV-associated FLA during a 12-month follow-up.
Design, Setting, and Participants: Open-label, safety and efficacy study in patients with HIV-associated FLA, a Carruthers Lipoatrophy Severity Scale (CLSS) grade of 2 or greater (range, 1-4, with higher scores indicating greater severity), and no previous treatment for FLA during the past year received 1 treatment and an optional touch-up. Twenty patients were treated and followed up at the Sacramento Veterans Affairs Medical Center, Mather, California, from March 5, 2015, to May 17, 2016.
Interventions: Midface (cheeks and temples) volumization was performed using the “smile-and-fill,” fanning, and depot technique with an optional touch-up at the 2-week follow-up.
Main Outcomes and Measures: Patients underwent evaluation at the initial visit and follow-up at 2 weeks and 3, 6, 9, and 12 months. Main outcome measures included safety (rate of treatment-related adverse events), CLSS grade, and Global Aesthetic Improvement Scale rating (5-point scale, ranging from worse to very much improved).
Results: Nineteen of the 20 patients (all men; mean [SD] age, 57  years) completed all study visits. Baseline HIV-associated FLA severity was CLSS grade 2 in 16 patients; grade 3, in 3 patients; and grade 4, in 1 patient. The total mean (SD) volume of HA used was 6.1 (3.1) mL for grade 2 FLA; 9.3 (4.2) mL for grade 3 FLA; and 26.0 (0) mL for grade 4 FLA (1 mL equals 1 syringe of HA filler). All 19 patients maintained a significant improvement of CLSS (grade 1) and Global Aesthetic Improvement Scale rating (very much improved) with no treatment-related adverse events at 12 months.
Conclusions and Relevance: This study reports excellent safety and efficacy and supports use of this HA filler for treatment of HIV-associated FLA with durable results at 12 months. Future multicenter, randomized clinical trials with blinded independent investigators are needed to demonstrate the long-term safety, efficacy, and durability of this HA filler for treatment of HIV-associated FLA.
Derek Ho; Jared Jagdeo