The US Food and Drug Administration this week approved the first treatment in the US specifically indicated for facial fat loss, or lipoatrophy. Called Sculptra, or polylactic acid, the treatment uses a series of injections into the facial tissue to stimulate the production of collagen, which in turn thickens the facial tissue, leading to the partial or complete restoration of the facial features. The substance does not stimulate new fat production.
Sculptra is known as New-Fill in Europe, and is already widely used in France and the United Kingdom as a treatment for facial fat loss in people with HIV.
US approval was based on the results of four clinical studies which followed patients for up to two years and reported sustained responses to Sculptra treatment. As a condition of approval, Sculptra’s manufacturer Dermik has agreed to conduct an open-label registry study of 100 patients for five years to evaluate Sculptra's long-term safety. The study will include at least 30 females and 30 people with dark skin types.
Facial fat loss occurs in people with HIV when fat pads in the cheek and temples shrink, leaving a hollow and gaunt facial appearance.
The cause of fat loss is not fully understood, but facial fat loss in people with HIV appears to be a side-effect of treatment, with people who have received past treatment with stavudine (d4T) plus a protease inhibitor at particularly high risk. However, facial fat loss can also occur in people who have never been exposed to d4T; people with a pre-treatment CD4 cell count below 100 cells/mm3 are at particularly high risk, regardless of their treatment choices.
Facial fat loss has been shown to affect up to one third of people with HIV receiving treatment in some cross-sectional studies, and the psychological effects of fat loss are difficult for many people to bear. Pressure for the availability of treatment has been high, with some individuals importing New-Fill from Europe or travelling to Europe for treatment.