Study shows promising results for New-Fill
BY Advocate.com Editors
November 14 2003 12:00 AM ET
A new study of the lipoatrophy treatment New-Fill, a biocompatible and immunologically inert synthetic polymer, shows that the product may be useful in providing a long-term solution to the facial fat loss that is common among people being treated for HIV disease. New-Fill has been approved in Europe since 1999 for the treatment of facial wasting caused by HIV disease and the antiretroviral medications taken to combat it, as well as to reduce scars and wrinkles.
The 96-week study of 50 HIV-positive patients, conducted in France, showed that median facial fat thickness increased among study participants from nearly zero millimeters at the beginning of the trial to about seven millimeters by its conclusion. More than 40% of the study subjects had facial fat thickness of more than 10 millimeters at the conclusion of the study. No serious adverse events were observed during the study, and no patient stopped taking New-Fill due to side effects.
The study authors, writing in the November 21 edition of the journal AIDS, conclude, "The benefit of [New-Fill] for the correction of the facial lipoatrophy in HIV-infected patients was clearly demonstrated, with an evident aesthetic and quality of life improvement. The efficacy, safety profile, and the simplicity of the injection schedule of [New-Fill] make this filling material a potentially attractive treatment." The Food and Drug Administration is expected to review New-Fill for the treatment of HIV-related lipoatrophy in the first half of 2004.