Question: How safe are hyaluronic acid fillers in HIV-associated facial lipoatrophy and what are the results after a follow-up of one year?
Background: Facial lipoatrophy, characterized by a localized decrease in subcutaneous adipose tissue around the face, is common in HIV patients on highly active antiretroviral therapy (HAART) and may sensitively affect adherence. Effects on psychological well-being and thus quality of life are to be expected (it is a painful reminder of the continuation of the disease that should not be underestimated). The cheek and temporal and orbital regions are usually affected. The extent to which even a simple treatment with hyaluronic acid filler, 20 mg/mL, can help has now been investigated in a new US study published in JAMA Dermatology. Can it safely and effectively improve the natural appearance of the face over a year?
PATIENTS AND METHODS: Patients with HIV-associated facial lipoatrophy of grade 2 or higher on the four-grade Carruthers Lipoatrophy Severity Scale (CLSS) (Table 1) and with no previous treatment for this indication in the past year were included in the study. A total of 20 participants (all men, average age 57) received treatment with Juvederm Voluma® XC (Allergan, California) and optional touch-up two weeks later. Sixteen patients had a CLSS grade of 2, three patients had a grade of 3, and one had a grade of 4. The intervention was performed via “smile-and-fill” fan and depot technique for the midface (cheek and temporal region), developed by the paper’s coauthor Dr. Jagdeo. On average, a total filler volume of 6.1 mL was used for grade 2 lipoatrophy, 9.3 mL for grade 3 lipoatrophy, and 26 mL for grade 4 lipoatrophy. Patients were followed up at two weeks and at three, six, nine, and 12 months – although one patient could no longer be evaluated at the one-year follow-up due to a change of residence. At the two-week follow-up, 14 patients had received a touch-up with an average of 2.5, 2, and 8 mL (depending on the CLSS grade mentioned above). Main endpoints were safety, i.e., occurrence of treatment-associated adverse events, CLSS grade, and the five-grade Global Aesthetic Improvement Scale (0 worsened to 4 very much improved). The trial was open-label, so patients and practitioners knew about the type of therapy.
Results and authors’ conclusion: All 19 patients who could be evaluated at the final follow-up after one year showed a durable and significant improvement on the CLSS – namely a reduction to grade 1 immediately after the first treatment and thereafter over one year (p<0.001 to baseline) – and on the Global Aesthetic Improvement Scale (very much improved, grade 4). Treatment-associated persistent side effects were not found after twelve months. The authors therefore consider the result to be excellent (patients were 100% satisfied). Both safety and efficacy would support the use of the hyaluronic acid filler in question for HIV-associated facial lipoatrophy. Of course, multicenter randomized phase III trials that blind the assessment and include a more diversified sample with higher-grade lipoatrophy would be desirable, he said. This is the only way to definitively confirm the long-term safety and efficacy of the active ingredient in this indication. While other fillers are already FDA-approved for HIV-associated lipoatrophy, this study was a new approach or use of the filler in question, which is currently indicated for age-associated volume loss. This would expand the field of treatment.
Comment Dr. Kreyden: Hyaluronic acid augmentation in HIV-associated lipoatrophy.
Lipoatrophy can be considered a side effect of proteinase inhibitors introduced in 1996. The etiology is not yet fully understood. It is suspected that the nucleoside reverse transcriptase inhibitors induce targeted lipid degradation through mitochondrial toxicity. Fat loss is most evident on the extremities, gluteal and (as mentioned above) facial areas.
The quality of life in HIV-infected patients is already significantly limited by the chronic disease itself compared to the non-infected overall population. A cross-sectional study of 194 patients at CHUV (Geneva) showed a prevalence of lipoatrophy of 18.9% with a high negative impact on quality of life. Thus, 35.6% of respondents reported suffering from depression, 51.9% from anxiety symptoms, and 49.5% from feelings of inferiority, depending on the severity of lipoatrophy [1]. The possibility of restorative augmentation of the midface and cheek region thus makes a significant contribution to improving the quality of life.
Case report: a 45-year-old patient with HIV disease diagnosed since 1987 has been treated with HAART since 1996. Among them, over the years, there was increasingly pronounced lipoatrophy (grade 4 according to CLSS), especially in the midface and cheek area, but also gluteal. A planned autologous fat augmentation of facial lipoatrophy had to be cancelled due to lack of gluteal fat harvest. Thus, the indication for augmentation with highly cross-linked hyaluronic acid arose.
Due to the severity of the lipoatrophy, the augmentation procedure was divided into three sessions at four-week intervals – on the one hand, to limit the amount of hyaluronic acid to be injected per session, and on the other hand, to avoid changing the expression of the face too much in one session (changing the “look”). For quality assurance, it has been proven to inject no more than 8 mL (4 mL distributed per half of the face) per session.
In a first session, the midface, in the narrower sense the ozygomaticum region was volumized (total 6 mL), in the second session the cheek area (total 8 mL). The third session was used to augment the temporal region resp. to correct certain asymmetries (total 5 mL). A total volume of 19 mL HA (Teosyal® Ultimate) was thus augmented.
This step-by-step procedure allowed a full reconstruction of the facial volumes with a natural result (Fig. 1-3). The actual condition could be reassessed in each session and the target condition adapted to the new conditions in each case. In addition, overcorrections or (equally incorrect) undercorrections can be largely avoided by using the serial augmentation technique.
Augmentation with hyaluronic acid instead of autologous fat should have the advantage of a significantly longer duration of effect, as it can be assumed that the transplanted autologous fat will also be degraded by HAART treatment. In the specific case, a touch-up treatment with only 2 mL of hyaluronic acid had to be performed only after 16 months.
Postscript
When asked if his case could be published by means of image documentation, the patient said he hoped the publication would encourage more doctors to treat patients like him. Not only did it give him a new look, but it also gave him a decisive boost to his self-confidence. What was to be achieved…
Source: Ho D, Jagdeo J: Safety and Efficacy of a Volumizing Hyaluronic Acid Filler for Treatment of HIV-Associated Facial Lipoatrophy. JAMA Dermatol 2017; 153(1): 61-65.
Literature:
- Verolet CM, et al: Lipodystrophy among HIV-infected patients: a cross-sectional study on impact on quality of life and mental health disorders. AIDS Res Ther 2015; 12: 21.
DERMATOLOGIE PRAXIS 2017; 27(2): 22-25
