National report - Results of two parallel, prospective, open-label, North American studies demonstrate that treatment with the injectable filler consisting of microspheres of calcium hydroxylapatite (CaHA) in a carboxymethylcellulose gel carrier (Radiesse, BioForm Medical) provides safe, immediate and relatively durable restoration of facial volume in patients with HIV-associated lipoatrophy.
The two studies are comprised of a single center Canadian trial that enrolled 30 patients beginning in December, 2004, and a United States Investigational Device Exemption (IDE) study launched in June, 2004, that entered 100 patients through three investigational sites. Patients in the Canadian trial received an initial injection aiming to achieve full correction and touch-ups at one and six months if clinically indicated. Based on a Food and Drug Administration (FDA) protocol requirement, U.S. patients were brought to full correction at an initial injection and then could receive a touch-up as needed after one month and six months if clinically indicated. There were no volume limits or requirements for either the U.S. or Canadian study.
Collectively, the results from the two studies show the filler treatment has resulted in improvement in all patients based on both investigator subjective assessment on the Global Aesthetic Improvement Scale (GAIS) and statistically significant increases from baseline in cheek skin thickness. The benefits have been generally long-lasting, often persisting for 12 to 18 months, associated with high patient satisfaction, and have occurred without any serious adverse events or problems relating to material migration.
"Over the years I have used a variety of approaches to treat HIV-associated facial lipoatrophy. However, I have been most satisfied with Radiesse because in my hands it has produced the best results with the greatest ease of use and the least side effects," concurs Stacey L. Silvers, M.D., who is one of the investigators in the U.S. trial.
Dr. Silvers is an ear, nose and throat and facial plastic surgeon in private practice in New York. Joseph A. Eviatar, M.D., an oculoplastic surgeon in New York, and Michael I. Echavez, M.D., a plastic surgeon in San Francisco, are the other two investigators in the U.S. study.
BioForm Medical submitted a premarket approval application for treatment of HIV-related facial lipoatrophy in September, 2005.
Inclusion criteria were similar for the U.S. and Canadian studies. Patients had to be HIV positive with a CD4 count of 250 cells/mm3 or greater, a viral load of 5,000 copies/ml or less, at least 18 years old, on HAART therapy for more than three years, and have a grading of 2, 3 or 4 on the Carruthers Facial Lipoatrophy Severity Scale.
In both studies, three-month results from the GAIS assessment were analyzed as the primary efficacy endpoint. Changes at six months in GAIS and in cheek skin thickness at three and six months were evaluated as secondary endpoints, and those data are also being collected at later follow-up visits.
The study population in the U.S. FDA Investigational Device Exemption study is predominantly male (94 percent), and non-Hispanic Caucasian (56 percent), but also includes 25 percent Hispanic patients, 18 percent who are black and 1 percent Asians. About half of the patients were classified as having grade 2 lipoatrophy on the Carruthers grading scale, while 39 percent were categorized as grade 3, and 13 percent as grade 4.