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.

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy.

OBJECTIVE: To evaluate the efficacy and safety of tesamorelin, a growth hormone releasing factor analogue approved by the Food and Drug Administration in November 2010 for the treatment of lipodystrophy associated with HIV infection. DATA SOURCES: Literature was obtained through MEDLINE (1948-November 2011) and International Pharmaceutical Abstracts (1970-October 2011) using the search terms tesamorelin, TH9507, growth hormone releasing factor, and HIV-associated lipodystrophy syndrome. Additional publications were obtained through review of references within primary literature publications as well as pertinent Web sites. STUDY SELECTION AND DATA EXTRACTION: All articles published in English identified from the data sources were evaluated and all pertinent information was included. All studies relevant to the evaluation of efficacy and safety of tesamorelin in the management of HIV-associated lipodystrophy were included, with a focus on trials completed in humans. DATA SYNTHESIS: In 2 Phase 3 clinical trials and their pooled analyses, tesamorelin was proven to significantly decrease waist circumference and visceral adipose tissue (VAT) following 26 weeks of treatment. Both trials also demonstrated significant improvements in some subjective body image parameters. Both studies had 26-week extension phases that confirmed maintenance of VAT improvements on treatment without adverse impact on blood glucose and lipid parameters. Limited data support off-label uses of tesamorelin at this time. CONCLUSIONS: Tesamorelin is effective in improving visceral adiposity and body image in patients with HIV-associated lipodystrophy over 26-52 weeks of treatment. Potential limitations for its use include high cost and lack of long-term safety and adherence data. Tesamorelin provides a useful treatment option for management of patients with significant lipodystrophy related to HIV infection.

An economic evaluation of treatments for HIV-associated facial lipoatrophy: a cost-utility analysis.

INTRODUCTION: HIV-associated facial lipoatrophy (FLA) is a stigmatizing hallmark for persons living with HIV [PLWH], and can lead to poor social functioning, social isolation, and reduced labour force participation. Treatments for this condition are prohibitively expensive and are not publicly insured in the Province of Ontario, Canada. Information gleaned from an economic evaluation of treatments for FLA could inform policy decision making concerning coverage. METHOD: Decision-analytic techniques were used to estimate the lifetime incremental costs and quality-adjusted life years (QALYs) gained from use of either Poly-l-lactic acid or Polyalkylimide gel from the perspectives of society and the Ontario Ministry of Health. Disease progression probabilities and utilities were derived from the literature. Costs were obtained through interviews with product distributors and physicians who perform these treatments. Costs were valued in 2009 Canadian Dollars. Costs and outcomes were discounted annually at 3%. FINDINGS: Treatments using Polyalkylimide gel exhibit such a cost advantage over those using Poly-l-lactic acid that they more than compensate for the health-related quality of life advantages of Poly-l-lactic acid. From a Ministry of Health perspective, the incremental cost-utility ratios for Polyalkylimide gel or Poly-l-lactic acid compared to no treatment were $45,457 CAD or $57,352 CAD per QALY, respectively, $1.00 CAD = $0.876 USD). From a societal perspective the equivalent ratios were $48,583 CAD and $66,608 CAD respectively. These findings were not altered in the sensitivity analyses. CONCLUSION: FLA treatments for PLWH enhance QALYs and meet conventional cost-utility thresholds. The incremental cost per QALY for Polyalkylimide gel was lower than that for Poly-l-lactic acid.