National report — The U.S. Food and Drug Administration (FDA) has approved the injectable filler, Sculptra, for correction of lipoatrophy in people with human immunodeficiency virus (HIV) infection. Manufactured by Dermik Laboratories,the U.S.-based dermatology arm of Aventis, Sculptra becomes part of a growing armamentarium of FDA-approved fillers and injectables. The FDA says it expedited review of the injectable poly-L-lactic acid because of its importance to people with HIV/AIDS, whose physical symptoms — hollow eyes, indentations, and sunken cheeks — often have negative psychological effects, including anxiety and depression. The product, known in Europe as New-Fill, has been shown to produce significant increases in skin thickness, adding volume to facial tissue and restoring shape in areas of the face with fat loss. It is estimated that of the 900,000 to 1 million people in the United States who are HIV-positive, some 50 percent will develop lipoatrophy. An estimated 150,000 to 350,000 patients could potentially benefit from the new treatment. "Until now, there have been no treatments approved by the FDA specifically for (lipoatrophy)," says Marcus Conant, M.D., clinical professor, University of California, San Francisco Medical Center. "Sculptra is a well-tolerated, breakthrough treatment that can be administered during an outpatient office visit and offers long-lasting results." In one research study, Sculptra was used in 277 HIV-positive patients with severe facial lipoatrophy. The patients, who were all being treated with antiretroviral drugs, were primarily white males, mostly ages 41 to 45. Patients were given three to six injections of Sculptra at two-week intervals and were followed for two years. The study showed that the product was safe and significantly improved facial appearance. Most adverse events were related to the injection itself and included nodules, redness, swelling and bruising in the injection area.Currently, Sculptra is only FDA-approved for use in patients with HIV, and is not approved for wrinkle treatment. This concerns some cosmetic surgeons, who say they applaud the use of the product for HIV patients, but wonder, over the long term, about its cost and availability for cosmetic procedures. "Once the FDA opens up the restrictions on Sculptra, I think that it will be one of the fillers on the market that will be competitive, based on cost and usefulness," says James Carraway, M.D., of Virginia Beach, Va. "With the advent of Restylane, Perlane, non-allergic collagen and Radiance, we have a good, wide variety," he adds. David H. McDaniel, M.D., of Norfolk, Va., is less concerned about the FDA restriction. "I think we will see off-label use of Sculptra, particularly for cases where fat grafting (due to volume) might have been used," he says. As a condition of approval, 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. Commercial availability of Sculptra is expected in the third quarter of this year, the company says. |
