HIV Digest	HIV Digest Archive

The US Food and Drug Administration last month announced its approval of Sculptra-- the first treatment specifically for the loss of facial fat that can leave HIV patients' faces gaunt and sunken. The substance, a form of polymer, has been used for decades to make dissolvable stitches. Since 1999, it has been used as in injectable wrinkle filler in Europe.

No one is sure what causes lipoatrophy-- the fat loss-- although it seems to be associated with HIV therapies. An estimated 20-50 percent of HIV patients experience the condition to some degree. The sunken cheeks and eyes can dramatically affect quality of life for patients severely affected.

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In announcing its approval, FDA cited studies showing that Sculptra improved facial shape and appearance when injected into sunken areas of HIV patients' faces. The improvements may last two years; however, FDA cautioned that repeat treatments may be necessary as the substance breaks down.

Skin nodules, redness, swelling and injection-site bruising are among side effects. But because studies to date have mainly focused on white men, FDA is requiring Dermik Laboratories, Sculptra's maker, to conduct a five-year study whose 100 participants must include at least 30 women and 30 patients with dark skin.

Sculptra should be used only by health professionals familiar with Dermik's training materials, FDA said, and is not approved for cosmetic wrinkle-filling. Aventis, Dermik's parent company, declined to reveal its planned price for Sculptra.

Editor's Note: from the Associated Press