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Approval of Sculptra Recommended

March/April 2004

One of the more disabling side effects of antiretroviral therapy is loss of fat in the face known as facial wasting, or lipoatrophy. Fat loss in the cheeks and temples has been associated with the use of nucleoside reverse transcriptase inhibitors (NRTI) and most strongly with the use of Zerit. Many people who have enjoyed a dramatic recovery of health after starting therapy have found that the onset of facial wasting can be as identifying and stigmatizing as the wasting of AIDS. Some people with severe facial wasting have reported being unable to leave the house and conduct their normal business due to depression and extreme discomfort about their appearance. For many people with long-term exposure to HIV drugs, facial wasting has posed a significant barrier to fully participating in society or returning to work.

On March 25, 2004, an advisory committee to the Plastic and Reconstructive Surgical Devices Branch of the federal Food and Drug Administration (FDA) met to consider the evidence submitted in support of a new, implantable substance intended to build up fat-depleted tissues in the face. The substance, poly-L-lactic acid, is called Sculptra by its sponsor, Dermik Laboratories, although it has been better known in Europe and in HIV community press reports as New-Fill. The proposed indication for Sculptra is to "correct shape and contour deficiencies" resulting from facial fat loss in people with HIV. The FDA granted an expedited review of the Sculptra application because they felt the product addressed a debilitating condition, represented an unmet medical need, and was in the best interest of patients.

According to observers at the hearing, despite a rather sparse presentation of data demonstrating the efficacy of Sculptra, it may have been dramatic testimony by individuals who had suffered the debilitating effects of facial wasting and who had benefited from treatment with the product that convinced panel members to vote for approval in the "best interest of patients."


Did it Work?

In a 50-person French efficacy trial, the main study outcomes were total cutaneous thickness (TCT) as measured by ultrasound and a series of photographs taken at baseline and after various stages of treatment. TCT generally showed the greatest improvement early in treatment and the selected photographs presented could be described as convincing demonstrations that the treatments were effective at restoring a normal appearance in the cheeks. Patients also reported improved quality of life soon after receiving treatments. A 30-person study conducted in London produced similar improvements in skin thickness and patient satisfaction as well as reductions in depression and anxiety. In several open-label U.S. studies, photographs showed less striking changes than were seen in the French photos; nonetheless, patient satisfaction with the treatment was high.

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The FDA and the panel was generally convinced of the product's safety. Only a few adverse events associated with Sculptra have been reported, primarily bruising, injection site reactions or the development of nodules or granulomas at the injection site. Poly-L-lactic acid is a synthetic polymer supplied in the form of microparticles of irregular shape that are injected below the skin. Eventually, the substance seems to degrade into harmless chemicals within the body. Unfortunately, gradual degradation may mean that periodic touch-ups will be required to keep treated areas from fading away. Longer-term studies will be needed to address this concern. Additional questions about cost and recommended training for providers who will administer Sculptra are still to be determined.


I delivered my story about how I wanted to remain anonymous with this disease and how lipoatrophy stripped me of that ability ... How, if it wasn't for lipoatrophy, I could essentially live a fairly normal life with HIV. How people who were unaware of my diagnosis, such as family members, friends and co-workers, became concerned about my "failing health" and how I passed up consulting job opportunities since I would never be comfortable with face-to-face interaction.

-- "Anonymous," on her testimony to the FDA panel.




  
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This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.
 

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