Sculptra wins FDA nod

National report — HIV patients who suffer from lipoatrophy now have access to the injectable filler Sculptra (Dermik Laboratories, Berwyn, Pa.) specifically for the correction of facial fat loss. The U.S. Food and Drug Administration (FDA) expedited its review of Sculptra and approved the drug for commercial use on Aug. 3.

Sculptra, an injectable poly-L-lactic acid (PLA), is the only FDA-approved filler for treating facial lipoatrophy related to human immunodeficiency virus (HIV), reducing a sunken appearance in the cheek, temple and eye areas.

Dr. Michael Echavez, M.D., a San Francisco-based plastic surgeon, has treated about 400 HIV-related lipoatrophy patients with injectable PLA filler within the past three years, and has also seen the psychological repercussions of lipoatrophy.

"Some patients are clinically depressed because of their appearance," says Dr. Echavez. "I've seen some studies where patients opt to stop taking their anti-retroviral medications in order to stop the progression of lipoatrophy. Some would trade years of their life not to have lipoatrophy."

Cause uncertain Studies differ on the exact cause of lipoatrophy in HIV patients. Some indicate it's simply an effect of the AIDS infection. But the more prominent theory places the cause on the antiretroviral medications (which have many side effects) used to prolong the lives of those with HIV. Of the 900,000 to 1 million people in the United States who are HIV-positive, it's thought that 50 percent will develop lipoatrophy. The FDA estimates 150,000 to 350,000 patients could potentially benefit from the new treatment.

The FDA's approval of Sculptra was based on a review of clinical studies submitted by the manufacturer, Dermik. The company reported on the use of Sculptra in 278 HIV-positive men with severe facial lipoatrophy, mostly between ages 41 and 45. All patients were being treated with antiretroviral drugs. Patients were given three to six injections of Sculptra at two-week intervals and were followed for two years. Dermik will continue the studies by conducting an open-label registry study of 100 patients for five years to evaluate Sculptra's long-term safety.

Dr. Echavez says he has seen his patients' quality of life improve once their facial concavities are corrected. And he believes that Sculptra's FDA approval signifies a positive turn in treating the condition.

"Now that it is FDA-approved, more people will be aware of the product and what it can be used for," he says.

Dr. Echavez has used other fillers to correct facial concavities, such as collagen and Cymetra (LifeCell, Branchburg, N.J.), but found their effects didn't last long. He also uses soft tissue implants, but says they are limited in that they can only treat the upper part of the face, and they require a more invasive and complex procedure to administer.

Longer process Of all the fillers he works with, he says, "At this point, I think that I do prefer Sculptra. The results are natural-looking; there's no recovery period. But there is a longer process involved than with other fillers."

That longer process is due to characteristics specific to injectable PLA, the biodegradable and biocompatible material used in dissolvable stitches and soft tissue implants. Once it's injected, it increases the thickness of the skin in the treated areas, by stimulating the body's tissue to produce collagen fibers, thus improving the appearance of fat loss. However, the process of collagen production is gradual, and it takes longer to see the end result.

Dermik recommends that physicians limit the volume of Sculptra to 0.1 mL to 0.2 mL for each individual injection, adding that in the cheek area, approximately 20 injections might be needed.