Injectable poly-L-lactic acid for human immunodeficiency virus-associated facial lipoatrophy: cumulative year 2 interim analysis of an open-label study (FACES).

BACKGROUND: Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. OBJECTIVE: To report cumulative year 2 interim study results examining the safety and efficacy of injectable PLLA in subjects with HIV categorized according to Fitzpatrick skin type and sex. MATERIALS AND METHODS: This is an ongoing open-label, multicenter, 5-year study of 290 treated subjects. After correction with injectable PLLA, subjects are being followed annually. Primary end points include incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points include mean change from baseline of James scale severity grade and treatment satisfaction. RESULTS: At 2 years, TEAE incidences were: potentially related to study product (n = 53,18.3%) or injection procedure (n = 71, 24.5%), injection-site nodules (n = 24, 8.3%) and papules (n = 25, 8.6%). No hypertrophic scars, keloids, or product-related serious TEAEs were reported. Mean improvement in James scale grade for all groups was 1.4 (p < .001), and 89.4% of subjects and 95.5% of physicians rated treatment satisfaction as very good or excellent. CONCLUSION: At 2 years, injectable PLLA is a safe and effective long-term treatment for HIV-associated facial lipoatrophy regardless of Fitzpatrick skin type; confirmation of these results will be needed at the completion of this 5-year study.

The generation challenge programme platform: semantic standards and workbench for crop science.

The Generation Challenge programme (GCP) is a global crop research consortium directed toward crop improvement through the application of comparative biology and genetic resources characterization to plant breeding. A key consortium research activity is the development of a GCP crop bioinformatics platform to support GCP research. This platform includes the following: (i) shared, public platform-independent domain models, ontology, and data formats to enable interoperability of data and analysis flows within the platform; (ii) web service and registry technologies to identify, share, and integrate information across diverse, globally dispersed data sources, as well as to access high-performance computational (HPC) facilities for computationally intensive, high-throughput analyses of project data; (iii) platform-specific middleware reference implementations of the domain model integrating a suite of public (largely open-access/-source) databases and software tools into a workbench to facilitate biodiversity analysis, comparative analysis of crop genomic data, and plant breeding decision making.

Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with human immunodeficiency virus-associated lipoatrophy: one-year durability.

BACKGROUND: The objective was to evaluate the safety and effectiveness of soft-tissue augmentation of calcium hydroxylapatite (Radiesse) in patients with facial lipoatrophy secondary to human immunodeficiency virus disease. METHODS: This 18-month, prospective, open-label, multicenter clinical trial of calcium hydroxylapatite for soft-tissue augmentation of patients with facial lipoatrophy enrolled 100 subjects (94 men and six women). RESULTS: Correction of facial lipoatrophy was evaluated by comparing changes from baseline using the Global Aesthetic Improvement Scale, with confirmation using standardized photography. All 100 patients were determined to be improved or better at 3 months. Secondary effectiveness endpoints-improvement at 6 months on the scale and skin thickness measurements at 3 and 6 months-were also met. Twelve-month data and 18-month scale scores were also available. One hundred percent of assessable patients were rated as improved or better on the scale at every time point through 12 months; 91 percent were improved or better at 18 months. "Yes" responses to all patient satisfaction questions ranged from 97 percent to 100 percent at every evaluation through 12 months. In addition, skin thickness measurements at 12 months remained statistically better than those at baseline. Eighteen-month patient satisfaction and skin thickness measurements were not available at the time of submission. Adverse events reported through 12 months were generally mild (ecchymosis, edema, erythema, pain, and pruritus), not unexpected, and generally short in duration. Eighteen-month safety data were not available at the time of submission. CONCLUSIONS: Radiesse is an appropriate and well-tolerated treatment for patients with facial lipoatrophy. It demonstrates an excellent safety profile, causes immediate augmentation of the soft tissues, and appears to provide relatively long-lasting improvement in appearance, with very high patient satisfaction.

Relationship between lipoatrophy and quality of life.

An informal yet comprehensive literature review of abstracts published in Medline was undertaken to identify papers that reported on how facial aging, lipodystrophy, and facial lipoatrophy affect quality of life. Facial lipoatrophy can erode self-esteem, cause psychological distress, and lead to depression. Persons with HIV infection encounter both stigmatization and marginalization as a result of facial lipoatrophy. In addition to exploring novel antiretroviral therapies that do not result in lipodystrophy, clinicians should consider treatments that correct the appearance of lipoatrophy for patients who feel adversely affected by the condition.