Poly-L-lactic acid (PLLA)- based injectable gives HIV/AIDS patients suffering from disfiguring facial lipodystrophy hope. Dr. Cheryl M. Burgess talks technique.
Cheryl M. Burgess, M.D.Cheryl M. Burgess, M.D., was among the first dermatologists in the United States to inject HIV patients suffering from disfiguring facial lipodystrophy with poly-L-lactic acid (PLLA, Sculptra Aesthetic, Galderma). The Washington D.C.-based dermatologist says using the filler, which has been approved by the U.S. Food and Drug Administration (FDA) to treat facial lipodystrophy since 2004, has become the mainstay of treatment and a quality-of-life saver for these patients.
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Ironically, use of life-saving highly active antiretroviral therapy (HAART) is associated with lipodystrophy syndrome, also known as lipoatrophy. Dr. Burgess, lead author on one of the first U.S. papers on the use of PLLA for HIV-associated lipodystrophy in Feb. 2005, in the Journal of the American Academy of Dermatology (JAAD). In it, she reported that from 15% to 80% of patients on HAART develop facial lipoatrophy within 10 months of starting the therapy.
The sometimes extensive facial fat-wasting that results is among the most stigmatizing complications of HIV, and the disfigurement often leads to poor body image, low self-esteem and depression, according to Dr. Burgess.
“Disfigurement and deformities [such as facial lipoatrophy] can cause profound psychological effects on the patient with respect to behavior alterations, reluctance to social interaction and occasionally high levels of anxiety about meeting new people,” Dr. Burgess says. “Due to the advancement of non-invasive cosmetic procedures, many individuals are now seeking cosmetic advice and recommendations.”
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By using collagen-stimulating fillers for pan facial enhancement, dermatologists can greatly improve the appearance of patients affected by facial wasting, according to Dr. Burgess, who spoke on the topic at the annual meeting of the American Society for Dermatologic Surgery (ASDS) (Chicago, October 2015).
Before the FDA approved PLLA (originally named New Fill) for soft tissue augmentation in HIV-associated facial lipotrophy, physicians in the United States had primarily collagen fillers and fat for volumizing the face, according to Dr. Burgess.
“Collagen wasn’t suitable for the correction of HIV-associated facial lipoatrophy,” Dr. Burgess says. “It would have been cost-prohibitive and wouldn’t have lasted [more than six months].”
New Fill had been approved for lipoatrophy treatment in Europe and Mexico; however, the FDA allowed buyer’s clubs in the United States to dispense a very limited number of New Fill vials for the treatment of lipoatrophy in HIV/AIDS patients. Dr. Burgess was one of only about 13 doctors treating patients by way of the New York Buyers’ Club, a not-for-profit group that provides treatment access and information to patients with HIV, hepatitis and other chronic diseases.
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“When I started treating HIV/AIDS-associated facial lipoatrophy in the early 2000s with poly-L-lactic acid (PLLA) to restore facial contours, I had patients coming from all over the United States to get treatment. Although it was available in Europe and Mexico, it was a novel treatment and U.S. physicians weren’t proficient in the injection technique, which differed vastly from collagen fillers,” Dr. Burgess says. “In desperation, my patients weren’t concerned with my level experience - they just wanted to look normal and not appear as if they had AIDS.”
Today’s Sculptra is an ideal filler for pan facial enhancement, according to Dr. Burgess.
“It’s a preparation that is injected subdermally,” she says. “On average, it takes three to four treatments, [at] four-to six-week intervals to see correction of facial concavities.”
In the study, 61 immunocompromised, HIV-infected male patients had an average three treatment sessions with PLLA over a five-month period for facial lipoatrophy. At the six-month follow-up, all the patients had a successful outcome - one which researchers defined by smoother skin with less concavities or depressions and improved overall appearance.
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Patients were happy with their results, according to the study, but two developed persistent asymptomatic palpable intradermal papules in the infraorbital region. That, according to the authors was as a result of the reconstitution dilution and superficial dermal injections near the orbital region. The researchers found that reconstitution at any dilution caused the filler to clump in the syringe and, to avoid the papules, dermatologists should inject the PLLA in the subcutaneous-deep dermal plane, avoiding hyperkinetic areas, such as the periocular or perioral regions.
At the 18-month follow-up, 13 of 61, or 21%, of patients asked for additional treatment sessions, beyond the initial three. The effect lasted up to two years in some patients, and the treatment was well tolerated, according to the study.
Dr. Burgess says that while treatment with PLLA for this condition is often successful, dermatologists should not over-promise results.
“It is better to under promise and over deliver results in the reconstruction process,” she says. “Generally, patients with deformities or disfigurements are very grateful for any attempts that are made to improve or correct their condition.”
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The rewards from impacting a patient’s outlook on life by using non-invasive procedures that can be performed in the office are immeasurable, according to Dr. Burgess.
“Although it has been over 15 years of treating HIV/AIDS-associated facial lipoatrophy, I still get teary eyed when I see the flow of tears come from the patient when they look in the mirror,” she says.
Dermatologists who offer to treat these patients, however, should be current on the possible options available to address deformities and disfigurements. Those who do not perform the treatments, should refer these patients to physicians who are capable of addressing the specific concerns of patients with this and other disfigurements, she says.
Disclosure: Dr. Burgess is on the advisory board for Galderma.