What is HIV-associated lipodystrophy?
Key elements of lipodystrophy, also called "Fat Redistribution Syndrome," include central fat accumulation (the abdomen, the upper back "buffalo hump," and the internal organs), and peripheral fat loss (the face, particularly the cheeks and temples, as well as the arms and legs). Metabolic complications, such as hyperlipidemia (elevated cholesterol and triglycerides), impaired glucose tolerance, and diabetes may also be present. Any given patient may have one or several of these symptoms.
Facial lipoatrophy, or facial wasting as it is also called, is usually the most distressing symptom of lipodystrophy. While clothing may be used to camouflage other affected areas of the body, the face cannot be concealed.
Is there a treatment for HIV-associated lipodystrophy?
Metabolic complications associated with HIV-associated lipodystrophy such as hyperlipidemia and diabetes should be carefully monitored and treated by a primary care physician. The cosmetic aspects of HIV- associated lipodystrophy, such as facial wasting and "buffalo hump," may be addressed by a dermatologist with expertise in cosmetic dermatology and HIV-associated lipoatrophy.
Do protease inhibitors cause facial wasting?
Although lipodystrophy is widely associated with highly active anti-retroviral therapy (HAART), there is no consensus on the roles played by HIV infection, drug therapy, the long-term survival offered by drug therapy, gender, age, or other factors. It is possible that the effects of different drugs and/or drug classes are interactive. Any changes to or discontinuation of HIV medication regimes should be discussed with your primary care provider.
Is there a treatment for HIV-associated lipoatrophy, or facial wasting?
There is no medication that will "cure" HIV- associated lipoatrophy, or facial wasting; however, the appearance of facial wasting can be significantly improved with various soft tissue augmenting agents.
At this time (October 2003) the only legally marketed soft tissue augmenting agents are Zyderm® and Zyplast®, or bovine collagen, as well as Cosmoderm® and Cosmoplast®, human fibroblast derived collagen. Although collagen injections can significantly improve facial wasting, relatively large volumes of the material are required, and collagen is absorbed by the body after a period of time, requiring repeat treatments, making collagen financially out of reach for most patients. Fat transplantation may be an option for selected patients, however, many lipoatrophy patients do not have sufficient reserves for fat transplantation and fat is generally not long lasting. Furthermore, fat transplantation involves significant bruising and swelling which may take weeks to resolve.
Other methods that have been used to improve facial wasting are facelifts and implants. Facelifts may improve facial sagging but cannot "replace" lost tissue. Implants will help to replace lost volume but often fail to provide optimal results due to contour irregularities. In addition, implants are not suitable for most of the affected facial areas, such as the temple and mid-cheek.
At this time, we believe liquid injectable silicone (LIS), using the Orentreich micro-droplet serial puncture injection technique is the best option for the treatment of facial wasting, because of the persistence of the correction and the ability to fill depressions without creating contour irregularities. Using LIS for soft tissue augmentation is an off-label use of this medical device.
What is off-label use?
Under U.S. FDA regulations, a physician may use any legally marketed drug or device for an indication other than the approved indication, provided certain criteria are met. Physicians may use Silikon™ 1000 as a treatment for HIV-associated lipoatrophy (and other indications), under off-label use regulations. Silikon™ 1000 is a legally marketed, FDA approved device used to treat retinal injuries. It is injected into the eye to act as a tamponade, providing a stabilizing retention force.
Are trials being conducted?
At this time, David S. Orentreich, MD is an investigator for a limited enrollment, FDA approved study (IDE G020092) entitled " A Clinical Trial to Determine the Safety and Effectiveness of Microdroplet Injections of SilSkin™ Silicone Oil for HIV-Associated Facial Lipoatrophy." This study will evaluate the clinical and quality of life improvement of patients with facial wasting after undergoing soft tissue augmentation with LIS.
A similar study in Canada has been approved and is currently underway.
Is there literature on this topic?
David S. Orentreich MD, has published his work in treating facial lipoatrophy with LIS in Dermatologic Surgery, a peer- reviewed professional journal, and has presented his work at dermatology conferences. He is also the co-author of a report on a multi-center study treating HIV -associated lipoatrophy, which has been accepted for publication in Dermatologic Surgery, and should appear with in the next six moths.
What is the difference between Silikon™ and SilSkin™?
Silikon™ 1000 is a one thousand centistoke silicone oil approved by the U.S. FDA for use as a prolonged retinal tamponade in selected cases of retinal detachment. Silikon™ 1000 may be used off-label for purposes other than retinal detachment under certain circumstances.
SilSkin™ is also a 1000 cc LIS, however, it is only available to FDA-approved investigators and the patients formally enrolled in FDA-approved trials.
Bear in mind:
Patients distressed by facial wasting may feel a sense of urgency when looking for treatment options. Clinics or persons offering unapproved materials or "treatments" should be avoided. Bear in mind the adage "If it sounds too good to be true," it probably is – at best. At worst, treatments may be deadly or disfiguring. It is important that any treatment option, including LIS, be discussed with your health care provider.