Comparing Efficacy and Costs of Four Facial Fillers in Human Immunodeficiency Virus-Associated Lipodystrophy: A Clinical Trial.

BACKGROUND: The objective of this study was to evaluate and compare the safety and effectiveness of four different dermal fillers in the treatment of facial lipoatrophy secondary to human immunodeficiency virus. METHODS: The authors conducted a clinical trial including 147 patients suffering from human immunodeficiency virus-induced lipoatrophy treated with Sculptra (poly-L-lactic acid), Radiesse (calcium hydroxylapatite), Aquamid (polyacrylamide), or autologous fat. Objective and subjective changes were evaluated during a 24-month follow-up. Number of sessions, total volume injected, and overall costs of treatment were also analyzed. A comparative cost-effectiveness analysis of the treatment options was performed. RESULTS: Objective improvement in facial lipoatrophy, assessed by the surgeon in terms of changes from baseline using the published classification of Fontdevila, was reported in 53 percent of the cases. Patient self-evaluation showed a general improvement after the use of facial fillers. Patients reported being satisfied with the treatment and with the reduced impact of lipodystrophy on their quality of life. Despite the nonsignificant differences observed in the number of sessions and volume, autologous fat showed significantly lower costs than all synthetic fillers (p < 0.05). CONCLUSIONS: Surgical treatment of human immunodeficiency virus-associated facial lipoatrophy using dermal fillers is a safe and effective procedure that improves the aesthetic appearance and the quality of life of patients. Permanent fillers and autologous fat achieve the most consistent results over time, with lipofilling being the most cost-effective procedure.

A systematic review of filler agents for aesthetic treatment of HIV facial lipoatrophy (FLA).

HIV facial lipoatrophy (FLA) is characterized by facial volume loss. HIV FLA affects the facial contours of the cheeks, temples, and orbits, and is associated with social stigma. Although new highly active antiretroviral therapy medications are associated with less severe FLA, the prevalence of HIV FLA among treated individuals exceeds 50%. The goal of our systematic review is to examine published clinical studies involving the use of filler agents for aesthetic treatment of HIV FLA and to provide evidence-based recommendations based on published efficacy and safety data. A systematic review of the published literature was performed on July 1, 2015, on filler agents for aesthetic treatment of HIV FLA. Based on published studies, poly-L-lactic acid is the only filler agent with grade of recommendation: B. Other reviewed filler agents received grade of recommendation: C or D. Poly-L-lactic acid may be best for treatment over temples and cheeks, whereas calcium hydroxylapatite, with a Food and Drug Administration indication of subdermal implantation, may be best used deeply over bone for focal enhancement. Additional long-term randomized controlled trials are necessary to elucidate the advantages and disadvantages of fillers that have different biophysical properties, in conjunction with cost-effectiveness analysis, for treatment of HIV FLA.

The pilot study of DXA assessment in chinese HIV-infected men with clinical lipodystrophy.

The aim of this study was to evaluate human immunodeficiency virus (HIV)-infected patient's body composition changes by dual-energy X-ray absorptiometry (DXA) and to analyze factors associated with lipodystrophy (LD). Total-body composition was measured by DXA in HIV-infected men and healthy men. HIV-infected men were divided into LD patients and non-LD patients according to whether they were complicated with LD. Healthy men were selected as controls. Fat mass (FM) of HIV-infected patients correlated negatively with the duration of HIV infection and with the duration of highly active antiretroviral therapy regimen (r(s)=-0.448 and -0.563; p=0.032 and 0.000, respectively). Multiple linear regression results showed that FM had positive correlation with weight and bone mineral content (BMC) and had negative correlation with lean mass (LM). Total body and regional FMs were found to be significantly different among LD patients, non-LD patients, and controls-the lowest in LD patients and the highest in controls (p<0.05). Total body, trunk, and leg BMCs of LD patients were lower than those of controls (p<0.05). Lumbar bone mineral density of LD patients was lower than that of non-LD patients and controls (p=0.04 and 0.007). LM of LD patients was higher than that of non-LD patients, and trunk LM had statistical difference between the 2 groups (p=0.003). Applying DXA to assess HIV-infected patient's body composition changes could provide objective information for physicians to prevent LD and osteoporosis.

Epidemiology, assessment, and management of excess abdominal fat in persons with HIV infection.

Metabolic and morphologic abnormalities in persons with HIV remain common contributors to stigma and morbidity. Increased abdominal circumference and visceral adiposity were first recognized in the late 1990s, soon after the advent of effective combination antiretroviral therapy. Visceral adiposity is commonly associated with metabolic abnormalities including low HDL-cholesterol, raised triglycerides, insulin resistance, and hypertension, a constellation of risk factors for cardiovascular disease and diabetes mellitus known as "the metabolic syndrome". Medline and conference abstracts were searched to identify clinical research on factors associated with visceral adiposity and randomized studies of management approaches. Data were critically reviewed by physicians familiar with the field. A range of host and lifestyle factors as well as antiretroviral drug choice were associated with increased visceral adiposity. Management approaches included treatment switching and metformin, both of which have shown benefit for insulin-resistant individuals with isolated fat accumulation. Testosterone supplements may also have benefits in a subset of individuals. Supra-physiological doses of recombinant human growth hormone and the growth hormone releasing hormone analog tesamorelin both significantly and selectively reduce visceral fat over 12-24 weeks; however, the benefits are only maintained if doping is continued. In summary, the prevention and management of visceral adiposity remains a substantial challenge in clinical practice.

Objective evidence for the use of polylactic acid implants in HIV-associated facial lipoatrophy using three-dimensional surface laser scanning and psychological assessment.

The advent of highly active antiretroviral therapy (HAART) has dramatically improved the life expectancy of people infected with human immunodeficiency virus (HIV). Although patients often have excellent disease control with these combinations of antiretrovirals, they are at risk for the multiple toxicities associated with these drugs. Facial lipoatrophy is a particularly distressing complication of some HAART regimes. This disfigurement can lead to significant psychosocial stress, resulting in decreased treatment compliance. Polylactic acid (PLA) facial implants provide a potential method of restoring a normal appearance. One hundred consecutive patients had a course of PLA facial implants. All patients were assessed clinically and had photographs, facial surface laser scans and completed psychological questionnaires throughout the course of treatment. After a mean of 4.85 treatments per patient, there were improvements in all measures. The mean clinical scores improved from a moderate-severe grade to none-mild grade after treatment. Three-dimensional (3D) laser surface scans showed a volume increase of 2.81 cc over the treated area of the cheek. There were significant improvements in all of the psychological measures. This study shows clear objective evidence of the psychological and physical benefit of PLA implants in HIV-associated facial lipodystrophy.

[Poly-L-lactic-acid filling of facial lipoatrophy in HIV+ patients under tritherapy]. / Comblement par l'acide L-polylactique des lipoatrophies faciales des patients VIH+ sous trithérapie.

Facial lipoatrophy is one of the complications of antiretroviral therapy in HIV+ patients. Poly-L-lactic-acid filling can compensate this atrophy. This treatment has been completely covered by social security since 2005. The filling technique is described in this article.

Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy.

BACKGROUND: Lipodystrophy syndrome is uniquely associated with the use of highly active antiretroviral therapy (HAART) containing protease inhibitors or nucleoside reverse transcriptase inhibitors. Between 15% and 80% of patients on HAART develop facial lipoatrophy within 10 months of initiating therapy. At present, no ideal treatment strategies have emerged in spite of the psychosocial stress, resulting in depression and isolation in many HIV-infected patients. Most soft tissue fillers seem to be well tolerated; however, various reactions such as allergic reactions, infection, and inflammatory and allergic granulomatous nodules are possible. Poly-L-lactic acid (PLA; New-Fill, Biotech Industry SA, Luxembourg) is currently being used in Europe and is approved by the Food and Drug Administration (FDA) in the United States for soft tissue augmentation in HIV-associated facial lipoatrophy. OBJECTIVE: To determine the safety and efficacy of PLA for dermal enhancement of facial lipoatrophy in immuncompromised HIV-infected patients with prior use of HAART. METHODS: Sixty-one immunocompromised, HIV-infected male patients (52 whites, 7 African Americans, 1 Latino, and 1 Asian) underwent multiple treatment sessions with PLA over a 5-month period for facial lipoatrophy. The severity of facial lipoatrophy was assessed and photographs were taken at baseline and before each treatment session. Periodic monitoring for adverse reactions and degree of improvement were assessed by the patient, the treating physician, and a non-treating physician. RESULTS: At the 6-month follow-up, all 61 immunocompromised HIV patients had a successful outcome, defined as smoothing of the skin with less concavities or depressions, and improved overall appearance in an average of 3 treatment sessions. Although all patients were very pleased with their results, two patients developed persistent asymptomatic palpable intradermal papules in the infraorbital region as a result of the site of placement and concentration of PLA. On long-term follow-up (18 months), 48 of 61 (79%) required an average of 3 visits to achieve the desired enhancement and 13 of 61 (21%) patients requested additional treatment sessions beyond the initial 3 sessions. Although the patient and the physicians rated the level of improvement as "Excellent," the desire for further dermal enhancement was purely subjective. In general, the procedures were well tolerated without the clinical development of adverse reactions. CONCLUSION: The use of PLA to treat facial lipoatrophy resulted in significant and prolonged improvement in HIV-infected patients. The effect was long lasting, for up to 2 years in some patients, depending on when treatment was initiated. There were no reported cases of infection, allergies, or serious adverse reactions, and the treatment was well tolerated.