The second and final part of this series focuses on the development of HIV-associated facial lipoatrophy, a condition dermatologists can treat with injectable fillers.
Highly active antiretroviral therapy (HAART) has had a very significant impact on the long-term survival of patients with HIV/AIDS. For patients who adhere to drug regimens and engage in additional healthy lifestyle practices, HIV infection can now be managed as a chronic disease.1,2
However, in the scope of the dermatologic management of HIV/AIDS, the long-term survival of these patients has introduced a new issue: lipoatrophy. Lipoatrophy, the localized loss of fat tissue, is one aspect of the larger lipodystrophy syndrome. The terms lipoatrophy and lipodystrophy can be – and are – used interchangeably, explains Dr. Marcus Conant, a dermatologist in San Francisco who was one of the first physicians to identify the symptoms of HIV and diagnose and treat AIDS patients in the early 1980s. He started seeing some of the first cases of lipodystrophy in HIV-positive patients around 1999.
“Lipoatrophy is the loss of fat,” Dr. Conant explains. “Lipodystrophy means the abnormal disposal of fat. Lipoatrophy of the face – or lipodystrophy of the face – means wasting in the face. The lipodystrophy syndrome includes facial wasting, buffalo hump (when the fat pad in the back of the neck becomes enlarged), abdominal obesity and swelling or increased fat in the mons pubis, right above the pubic bone. And there’s peripheral wasting – the loss of fat in the arms and legs. [HIV patients] also get insulin-resistant diabetes. All of that is the lipodystrophy syndrome. Patients come to dermatologists for the lipoatrophy of the face part of that syndrome.”
Lipoatrophy of the face in HIV-positive patients is associated with a negative impact on control of HIV disease and quality of life.3-5 Patients who experience lipoatrophy describe the volume loss as highly stigmatizing, and it can lead to depression, occupational issues and social isolation.3,4 However, the use of deep fillers has become an effective strategy dermatologists can offer HIV-positive patients who suffer from lipoatrophy.6
This article will review the development of lipoatrophy in HIV-positive patients, the potential mechanisms behind it and the treatment options dermatologists can offer patients to correct facial wasting. The impact of successful treatment for HIV-associated lipoatrophy of the face will also be explored.
Progression of HIV-Associated Lipoatrophy
Reports of lipoatrophy in HIV-positive patients began surfacing in the literature around the same time as the introduction of protease inhibitors, a class of drugs that are seen as a major advancement in the treatment of HIV.7 Other classes of HAART have been associated with the development of lipoatrophy, including reverse-transcriptase inhibitors.8 However, it is not clear whether facial wasting is due to the drugs themselves, the underlying HIV infection or the two factors in combination.
“We don’t know what causes lipodystrophy,” Dr. Conant explains. “It may be the drugs, but there are other factors. The trouble is that the reports you see are a few case reports – you put the whole picture together, and you talk to people who have been seeing these patients as I have for years and years and years, and you say, yes, you’ve seen patients who have been on the protease inhibitors. But they were also on the other drugs. So then we wondered, well, maybe it’s not the drugs – maybe patients didn’t live long enough before to get lipodystrophy, and so, consequentially, the drugs are keeping them alive, so it’s a problem related to the underlying HIV infection that’s now presenting itself. So, there are two possibilities – one that it’s the drugs and two that it was the HIV infection itself coupled with the number of years of survival. So, at the present time, I think we have to say: It is unique to HIV-infected people on treatment and we do not know the cause.”
One study describes HIV-associated lipoatrophy as a condition with “multifactorial etiologies related to the type of antiretroviral therapy, HIV disease and host factors rather than one entity.”8
Treatment with Fillers
According to Dr. Conant, treatment of HIV-associated facial lipodystrophy requires a semi-permanent deep filler. The two products used most often are Sculptra (poly-L-lactic acid [PLA]) and Radiesse (calcium particles). Sculptra and Radiesse are the only fillers specifically approved by the FDA for the treatment of HIV-associated facial lipoatrophy.
“Sculptra has a long history of treating HIV-associated lipoatrophy and has worked well,” explains Kenneth Beer, MD, a dermatologist in private practice in West Palm Beach, FL and a director of the Cosmetic Bootcamp meeting. “Radiesse also has the ability to treat facial volume loss and may be used to treat HIV-associated lipoatrophy.”
The nature of the filler treatment will vary depending on the degree of the patient’s facial volume loss, explains Joel Cohen, MD, FAAD, director of AboutSkin Dermatology and DermSurgery in Denver, CO.
“Grade 1 is some soft tissue loss,” Dr. Cohen explains. “Grade 2 is moderate soft tissue loss. Grade 3 is significant, such that you’re starting to get skin with very little soft tissue, and then Grade 4 is just skin on bone – there’s nothing in that compartment.”
The Facial Lipoatrophy Severity Scale was published by James, Carruthers and Carruthers in 2002, where the four grades of HIV-associated lipoatrophy are explained in detail.7
Dr. Cohen has been treating patients with HIV-associated lipodystrophy for about 10 years, and he believes Sculptra and Radiesse offer distinct advantages for treating this condition.
“With Sculptra, you take someone who’s Grade 3 or 4 and you do a couple treatments and it’s gradual,” Dr. Cohen explains. “There are other people who, after you do something gradual like that, you can switch to something like Radiesse. With Radiesse, you put it in and it’s there [immediately]. So there are some patients who say, ‘Make this gradual, I don’t want this to be corrected overnight – it’s Friday and I don’t want to look like a different person on Monday.’ That’s great – you start with Sculptra and you do some sessions and then maybe you switch them over to Radiesse to put the finishing touches on it. Then there are other people who come in and say, ‘Look, I’m starting a new job, and I have this condition, and people don’t know what I look like, and so I just want to look better, and my new job starts in two weeks.’ So, with those people, I would go right to Radiesse.”
Artefill and silicone can also be used for HIV-associated facial lipoatrophy, according to Dr. Beer. Artefill is a long-lasting dermal filler composed of bovine collagen and polymethylmethacrylate microspheres. Silicone is polymers of dimethylsiloxane composed of elemental silicon, oxygen and methane subgroups.
“Artefill and silicone last forever, but, with the loss of additional volume, patients will need touch-ups,” Dr. Beer explains.
Efficacy and Duration of Various Fillers
Sculptra
Poly-L-lactic acid (Sculptra) was approved by the FDA for the treatment of HIV-associated facial lipodystrophy in 2004.9 The data from the four studies that led to the approval of PLA for this indication demonstrate the product significantly improves facial appearance and was safe for restoration and/or correction of shape and contour deficiencies resulting from facial fat loss in HIV/AIDS patients.9
“People who have severe lipoatrophy – which means that they’ve lost all of the fat – will require something in the range of 6 to 12 bottles of Sculptra to correct the problem,” Dr. Conant explains. “People who have minor lipoatrophy or who start the treatments earlier will require only two or three bottles of polylactic acid to correct it. The polylactic acid will last a variable period of time. For most patients, they get good results for a year, year and a half. For many patients, especially those who have severe lipoatrophy, they begin to notice that they’re losing [the volume restoration] as early as 6 months.”
Studies investigating the use of PLA for HIV-associated facial lipoatrophy speak to the treatment’s efficacy for this indication.
In one study, participants received three treatment sessions, separated by fortnightly intervals, of bilateral injections of PLA into the deep dermis overlying the buccal fat pads.10 For each treatment, 0.15 g of PLA was reconstituted with 2 mL of sterile water for injection and 1 mL of 2% lidocaine for a total volume of 3 mL.10 The researchers injected up to 3 mL of reconstituted PLA into the treatment area.10 Patients in the delayed group commenced treatment 12 weeks after those in the immediate group.10
The researchers showed PLA has a favorable long-term safety and efficacy profile, with no serious or severe side effects reported in 2 years.10 Significant improvements in Visual Analogue Scores from baseline were noted as well as a trend for improvements in Hospital Anxiety and Depression Scale scores.10 The positive results of PLA treatment achieved at week 24 were maintained to the recall visit, up to 2 years after treatment initiation.10
A second study investigated the use of PLA in patients with all four grades of lipoatrophy.11 The distribution of severity among patients was Stage I (N=9); Stage II (N=15); Stage III (N=30); and Stage IV (N=7).11 After the initial treatment, 100% of patients noted at least a slight improvement of facial concavities (Grade 3, or ‘‘Fair’’).11 In all cases, the patient rated his appearance higher than the physicians, even when the physicians noted no change.11
A review of how Sculptra is used for the treatment of HIV-associated facial lipodystrophy reports the resulting change in skin thickness may persist from baseline for up to 2 years.12
Radiesse
Radiesse, a semi-solid cohesive implant of synthetic calcium hydroxylapatite suspended in a gel carrier, was approved by the FDA for HIV-associated facial lipoatrophy in 2006.13 The approval study involved a mean initial treatment volume of 4.8 mL and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month).13 At 6 months, the mean touch-up volume was 2.4 mL for almost 90% (89%) of patients.13 The majority of patients (78%) received a total of three treatments, while 4% received only one treatment and 18% had two treatments.13 No patient received more than three treatments.13
Treatment with Radiesse resulted in sustainable improvements in cheek thickness.13 At baseline, mean thickness of the left cheek was 4.7 mm (N=100).13 At 3 months, mean thickness of the left check was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline (P=0.0001).13 At 6 months, the mean thickness of the left cheek was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline (P=0.0001).13 For the right cheek, mean cheek thickness at baseline was 4.9 mm (N=100).13 At 3 months, mean thickness of the right cheek was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline (P=0.0001). At 6 months, the mean thickness of the right cheek was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline (P=0.0001).13
Other studies support the use of Radiesse for this indication. One investigation found that mean cheek thickness improved over 12 months, with the greatest improvement after 3 months.14 At all three points of measurement, the changes from baseline were highly statistically significant.14 In addition, 100% of patients reported satisfaction on all measurements of patient satisfaction at all time periods measured (3, 6 and 12 months).14
Generally, Radiesse results in sustained improvement through 12 months.15
The Effect of Treatment on Quality of Life
The negative impact of HIV-associated facial lipoatrophy is well documented in the literature and through the anecdotal experience of physicians. Lipodystrophy can inadvertently disclose an individual’s HIV status if the person lives in a community where lipodystrophy is well understood, such as a large city like San Francisco or New York, or where there are large populations of high-risk groups, particularly men who have sex with men. This change in facial structure can affect social and personal relationships, mood and quality of life and one’s ability to work.3,4,15 The condition can also negatively impact an individual’s adherence to HAART.3,15,16
“It’s one thing for society to care about people’s survival, but you have to care about their quality of life,” Dr. Conant says. “It’s not just enough to breathe in and out every day. It’s can you have friends, can you go out, can you be seen in public? It’s just as important. We, as a culture, have provided Social Security and other benefit programs for patients, but, unfortunately, we have not taken the steps necessary to provide for their quality of care. It’s the same as a woman who has had a breast removed – she’s going to want an implant. Someone who’s lost their face because of the disease – because of treatment for the disease – is going to want some sort of corrective procedure so they can live normally.”
The ability to use dermal fillers has significantly improved the appearance of this condition and, therefore, improved quality of life for these patients, Dr. Conant continues.
Dr. Cohen concurs.
“These patients are living longer, they’re much healthier, they actually look good – they don’t look like they have HIV and are on HAART therapy, and they don’t require as many treatments,” he says. “It’s something that I really enjoy doing. My staff knows this is an important part of my day when I see patients with this, and I can really help them through the stigma of appearing sick when they don’t feel sick anymore.”
Figure 1: Before (left) and after (right) photos of a patient injected with 2.6 cc of Radiesse for HIV-associated lipodystrophy. The follow-up photo was taken 2 weeks after the injection.
Photos courtesy of Joel Cohen, MD, FAAD
Editor's Note: Please click on each image to see the full-size version.
Two of Dr. Cohen’s patients described the impact that treatment for lipoatrophy has had on their quality of life.
Scott
Scott was diagnosed as HIV-positive in 1987, and he participated in many different case studies for any new drug that was introduced. He started to notice a gradual volume loss that quickly became apparent.
“I grew up as a speed skater to begin with, so I was very fit,” Scott says. “That only made it worse. Mainly, it was around the nose and mouth that looked really sunken in. You just look 20 years older. I would say, by the year 2000 or so, I was like, ‘Okay, what can I do?’”
Scott’s decision to seek treatment for his facial lipodystrophy coincided with his occupational move into education.
“You could look at people and you could tell,” Scott explains. “By the time the lipoatrophy started, I had moved into education, as a teacher and as a principal of an elementary school. Especially in the gay community, and even outside of there, you could tell who had [HIV] and who didn’t, just by the appearance of their face. I didn’t want to be seen that way.”
The treatment was life changing, Scott says, who discussed the impact of his improved facial appearance in relation to his HIV infection.
“I went from 53 T cells at one point to an undetectable viral load now,” Scott says. “There’s been a lot of lows in there, but you can’t go by your lows, necessarily. I think the mental aspect of it – and the way you look – and I’m not a person who’s over the top or anything like that, but I’m very athletic – is huge. As someone who once had a terminal disease, [the filler treatment] definitely makes you feel like a person again."
Richard
“I was diagnosed HIV positive in 1984,” Richard explains. “I started drug therapy as soon as there were drugs available. At first, there wasn’t anything – they just expected you to die within 6 months and told you to go home and get your affairs in order. I’ve been on any number of regimens for the past almost 30 years.”
Richard says it was about 10 years ago that he first started noticing the facial volume loss. He noticed the issue around the same time he was recovering from chemotherapy for rectal cancer, once he had started going back to the gym and working with a nutritionist and a personal trainer.
“My body looked great, but my face – I’d look in the mirror and think, ‘Oh, god, I have the AIDS face,’” Richard explains. “I don’t know if the general population is aware of the AIDS face, but anyone who has gay friends or who has been in the community – they know the look, the AIDS face. You [can] look at a room full of men and pick out the ones who are probably HIV-positive.”
A friend of Richard’s who is also HIV-positive told him about the filler treatment he had been receiving, which prompted Richard to see Dr. Cohen.
“It’s really hard to describe, emotionally, how [the filler treatment] makes you feel about yourself,” Richard explains. “It helps to improve your self-worth and your self-image. You wouldn’t think that a little bit of injecting someone could have that type of effect, but it’s on your face. Your whole outlook on life – when you don’t even feel like leaving the house – changes… It’s hard to really, unless you’re in our shoes and inside our brains, understand that this has a huge impact on your life and your whole outlook and how you feel about yourself and how you want to go out and interact with other people.”
Richard also reflected on the impact of the filler treatments in regard to the span of his HIV infection.
“We spent thousands of dollars on drugs and co-pays and doctor visits and tests,” he says. “Then we get to the point where they have these really great drugs out there that are going to keep us all alive, so you can continue to work and be a productive member of society and not be on disability and build your life and resume saving for retirement – because now you may live until retirement – and you look in the mirror and it’s like, ‘Oh god, everything’s good but this’ – but now there’s fillers to help with that.”
SIDEBAR: The Affordability of Dermal Fillers for HIV-Associated Lipoatrophy
The positive impact that filler treatments can have for patients with HIV-associated lipoatrophy is significant. However, the cost can be significant as well. According to Dr. Beer, Sculptra costs between $2,500 and $5,000, depending on how many bottles are required for treatment. He estimates each bottle costs about $800.
“Radiesse is a little more complicated,” Dr. Beer continues. “It comes in various size syringes, including 0.3 mL, 0.8 mL and 1.5 mL. Many places will advertise injections for $500 and then use a small syringe. I would estimate that most injectors who are experienced charge $800 or so for the 1.5 mL syringe, $500 for the 0.8 mL syringe and $350 for the 0.3 mL syringe.”
As a result, access to these treatments can be complicated by how expensive the treatments are, Dr. Conant explains.
“Some insurance companies, including Medicare, do offer payment for the procedure, but the amount they offer is not enough to encourage most providers to give it,” he continues.
According to information from the Centers for Medicare & Medicaid Services published in 2010, “Dermal injections for facial lipodystrophy syndrome are only reasonable and necessary using dermal fillers approved by the FDA for this purpose, and then only in HIV-infected beneficiaries who manifest depression secondary to the physical stigma of HIV treatment.”17
Patients can utilize programs to reduce the cost of this filler treatment. One example in the San Francisco Bay Area is Catholic Charities, according to Dr. Conant.
The makers of Sculptra and Radiesse both offer assistance programs to help patients pay for the treatment. The Radiesse Patient Access Program has specific patient qualifications, including income range, US citizenship status and more.18 Sculptra also offers a patient access program that helps patients afford the injections; as with Radiesse, there are patient eligibility requirements in order to receive Sculptra at reduced or no cost.19
For both Scott and Richard, the treatments are worth the expense.
“The biggest thing for me – and I can say this because I have friends that I’ve referred – is that, once you realize you can get that look back and not have these facial features – you will maintain it and do whatever you can, even in hard economic times, because, for your own self-esteem and reapplying for jobs now, it’s very important to look as good as you can and as healthy as you can,” Scott says.
Richard concurs.
“It’s a very expensive procedure,” Richard explains. “It’s unfortunate. It’s sort of in my yearly budget to allocate so much money for treatment. Now, I’m to the point where I usually go in once a year for what I call a tune-up. Before, I was going every 6 months, but I was making a lot more money than I am now. It was easier to afford. It’s worth the money, because it makes you feel better about yourself and how you look, and you can’t put a price on that.”
Be sure to read Part 1: Dermatologic Management of Patients with HIV/AIDS, Part 1: Cutaneous Manifestations and Complications.
References
1. AIDS.gov. Chronic manageable disease. https://1.usa.gov/10h68VS. Accessed May 20, 2013.
2. UNAIDS.gov. The HIV experience and other chronic diseases. https://bit.ly/OWu61H. Accessed May 20, 2013.
3. Moyle GJ. Cosmetic interventions for HIV-associated lipoatrophy. Medscape Education. www.medscape.org/viewarticle/548185. Published November 30, 2006. Accessed May 20, 2013.
4. Hornberger J, Rajagopalan R, Shewade A, Loutfy MR. Cost consequences of HIV-associated lipoatrophy. AIDS Care. 2009;21(5):664-671.
5. Bugge H, Negaard A, Skeie L, Bergersen B. Hyaluronic acid treatment of facial fat atrophy in HIV-positive patients. HIV Med. 2007;8(8):475-482.
6. Schweiger ES, Riddle CC, Wernli BJ, Tonkovic-Capin V. Comparison of poly-L-lactic acid and calcium hydroxylapatite for treating human immunodeficiency virus-associated facial lipoatrophy. Cosmet Dermatol. 2007;20(5):304-312.
7. James J, Carruthers A, Carruthers J. HIV-associated facial lipoatrophy. Dermatol Surg. 2002;28(11):979-986.
8. Hansen AB, Lindegaard B, Obel N, Andersen O, Nielsen H, Gerstoft J. Pronounced lipoatrophy in HIV-infected men receiving HAART for more than 6 years compared with the background population. HIV Med. 2006;7(1):38-45.
9. FDA. FDA approval of Sculptra for treating facial lipoatrophy. https://1.usa.gov/18icKVZ. Accessed May 22, 2013.
10. Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-associated facial lipoatrophy. HIV Med. 2006;7(3):181-185.
11. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52(2):233-239.
12. Dinman S. Sculptra use in HIV-associated lipodystrophy. Plast Surg Nurs. 2008;28(1):53-54.
13. FDA. FDA approves Radiesse for treating facial lipoatrophy. https://1.usa.gov/YZNZLv. Accessed May 22, 2013.
14. Carruthers A, Carruthers J. Evaluation of injectable calcium hydroxylapatite for the treatment of facial lipoatrophy associated with human immunodeficiency virus. Dermatol Surg. 2008;34(11):1486-1499.
15. UpToDate. Treatment of HIV-associated lipoatrophy. https://nihlibrary.ors.nih.gov/jw/POC/UHIVlipids.htm. Accessed May 22, 2013.
16. Serra MS, Oyafuso LK, Trope BM, Munhoz Leite M, Ramos-e-Silva M. An index for staging facial lipoatrophy and evaluation of the efficacy of the treatment with polymethylmethacrylate in HIV/AIDS patients: A pilot study. J Eur Acad Dermatol Venereol. Published online ahead of print July 9, 2012.
17. MLN Matters. Dermal injections for treatment of facial lipodystrophy syndrome (LDS). https://go.cms.gov/18iJmPc. Accessed May 22, 2013.
18. Radiesse. How much does it cost? www.radiesse-fl.com/What-is-Radiesse/How-much-does-it-cost/. Accessed May 22, 2013.
19. TheBody.com. Forum on facial wasting. Radiesse/Sculptra patient assistance programs. https://bit.ly/11vhPd4. Accessed May 28, 2013.
The second and final part of this series focuses on the development of HIV-associated facial lipoatrophy, a condition dermatologists can treat with injectable fillers.
Highly active antiretroviral therapy (HAART) has had a very significant impact on the long-term survival of patients with HIV/AIDS. For patients who adhere to drug regimens and engage in additional healthy lifestyle practices, HIV infection can now be managed as a chronic disease.1,2
However, in the scope of the dermatologic management of HIV/AIDS, the long-term survival of these patients has introduced a new issue: lipoatrophy. Lipoatrophy, the localized loss of fat tissue, is one aspect of the larger lipodystrophy syndrome. The terms lipoatrophy and lipodystrophy can be – and are – used interchangeably, explains Dr. Marcus Conant, a dermatologist in San Francisco who was one of the first physicians to identify the symptoms of HIV and diagnose and treat AIDS patients in the early 1980s. He started seeing some of the first cases of lipodystrophy in HIV-positive patients around 1999.
“Lipoatrophy is the loss of fat,” Dr. Conant explains. “Lipodystrophy means the abnormal disposal of fat. Lipoatrophy of the face – or lipodystrophy of the face – means wasting in the face. The lipodystrophy syndrome includes facial wasting, buffalo hump (when the fat pad in the back of the neck becomes enlarged), abdominal obesity and swelling or increased fat in the mons pubis, right above the pubic bone. And there’s peripheral wasting – the loss of fat in the arms and legs. [HIV patients] also get insulin-resistant diabetes. All of that is the lipodystrophy syndrome. Patients come to dermatologists for the lipoatrophy of the face part of that syndrome.”
Lipoatrophy of the face in HIV-positive patients is associated with a negative impact on control of HIV disease and quality of life.3-5 Patients who experience lipoatrophy describe the volume loss as highly stigmatizing, and it can lead to depression, occupational issues and social isolation.3,4 However, the use of deep fillers has become an effective strategy dermatologists can offer HIV-positive patients who suffer from lipoatrophy.6
This article will review the development of lipoatrophy in HIV-positive patients, the potential mechanisms behind it and the treatment options dermatologists can offer patients to correct facial wasting. The impact of successful treatment for HIV-associated lipoatrophy of the face will also be explored.
Progression of HIV-Associated Lipoatrophy
Reports of lipoatrophy in HIV-positive patients began surfacing in the literature around the same time as the introduction of protease inhibitors, a class of drugs that are seen as a major advancement in the treatment of HIV.7 Other classes of HAART have been associated with the development of lipoatrophy, including reverse-transcriptase inhibitors.8 However, it is not clear whether facial wasting is due to the drugs themselves, the underlying HIV infection or the two factors in combination.
“We don’t know what causes lipodystrophy,” Dr. Conant explains. “It may be the drugs, but there are other factors. The trouble is that the reports you see are a few case reports – you put the whole picture together, and you talk to people who have been seeing these patients as I have for years and years and years, and you say, yes, you’ve seen patients who have been on the protease inhibitors. But they were also on the other drugs. So then we wondered, well, maybe it’s not the drugs – maybe patients didn’t live long enough before to get lipodystrophy, and so, consequentially, the drugs are keeping them alive, so it’s a problem related to the underlying HIV infection that’s now presenting itself. So, there are two possibilities – one that it’s the drugs and two that it was the HIV infection itself coupled with the number of years of survival. So, at the present time, I think we have to say: It is unique to HIV-infected people on treatment and we do not know the cause.”
One study describes HIV-associated lipoatrophy as a condition with “multifactorial etiologies related to the type of antiretroviral therapy, HIV disease and host factors rather than one entity.”8
Treatment with Fillers
According to Dr. Conant, treatment of HIV-associated facial lipodystrophy requires a semi-permanent deep filler. The two products used most often are Sculptra (poly-L-lactic acid [PLA]) and Radiesse (calcium particles). Sculptra and Radiesse are the only fillers specifically approved by the FDA for the treatment of HIV-associated facial lipoatrophy.
“Sculptra has a long history of treating HIV-associated lipoatrophy and has worked well,” explains Kenneth Beer, MD, a dermatologist in private practice in West Palm Beach, FL and a director of the Cosmetic Bootcamp meeting. “Radiesse also has the ability to treat facial volume loss and may be used to treat HIV-associated lipoatrophy.”
The nature of the filler treatment will vary depending on the degree of the patient’s facial volume loss, explains Joel Cohen, MD, FAAD, director of AboutSkin Dermatology and DermSurgery in Denver, CO.
“Grade 1 is some soft tissue loss,” Dr. Cohen explains. “Grade 2 is moderate soft tissue loss. Grade 3 is significant, such that you’re starting to get skin with very little soft tissue, and then Grade 4 is just skin on bone – there’s nothing in that compartment.”
The Facial Lipoatrophy Severity Scale was published by James, Carruthers and Carruthers in 2002, where the four grades of HIV-associated lipoatrophy are explained in detail.7
Dr. Cohen has been treating patients with HIV-associated lipodystrophy for about 10 years, and he believes Sculptra and Radiesse offer distinct advantages for treating this condition.
“With Sculptra, you take someone who’s Grade 3 or 4 and you do a couple treatments and it’s gradual,” Dr. Cohen explains. “There are other people who, after you do something gradual like that, you can switch to something like Radiesse. With Radiesse, you put it in and it’s there [immediately]. So there are some patients who say, ‘Make this gradual, I don’t want this to be corrected overnight – it’s Friday and I don’t want to look like a different person on Monday.’ That’s great – you start with Sculptra and you do some sessions and then maybe you switch them over to Radiesse to put the finishing touches on it. Then there are other people who come in and say, ‘Look, I’m starting a new job, and I have this condition, and people don’t know what I look like, and so I just want to look better, and my new job starts in two weeks.’ So, with those people, I would go right to Radiesse.”
Artefill and silicone can also be used for HIV-associated facial lipoatrophy, according to Dr. Beer. Artefill is a long-lasting dermal filler composed of bovine collagen and polymethylmethacrylate microspheres. Silicone is polymers of dimethylsiloxane composed of elemental silicon, oxygen and methane subgroups.
“Artefill and silicone last forever, but, with the loss of additional volume, patients will need touch-ups,” Dr. Beer explains.
Efficacy and Duration of Various Fillers
Sculptra
Poly-L-lactic acid (Sculptra) was approved by the FDA for the treatment of HIV-associated facial lipodystrophy in 2004.9 The data from the four studies that led to the approval of PLA for this indication demonstrate the product significantly improves facial appearance and was safe for restoration and/or correction of shape and contour deficiencies resulting from facial fat loss in HIV/AIDS patients.9
“People who have severe lipoatrophy – which means that they’ve lost all of the fat – will require something in the range of 6 to 12 bottles of Sculptra to correct the problem,” Dr. Conant explains. “People who have minor lipoatrophy or who start the treatments earlier will require only two or three bottles of polylactic acid to correct it. The polylactic acid will last a variable period of time. For most patients, they get good results for a year, year and a half. For many patients, especially those who have severe lipoatrophy, they begin to notice that they’re losing [the volume restoration] as early as 6 months.”
Studies investigating the use of PLA for HIV-associated facial lipoatrophy speak to the treatment’s efficacy for this indication.
In one study, participants received three treatment sessions, separated by fortnightly intervals, of bilateral injections of PLA into the deep dermis overlying the buccal fat pads.10 For each treatment, 0.15 g of PLA was reconstituted with 2 mL of sterile water for injection and 1 mL of 2% lidocaine for a total volume of 3 mL.10 The researchers injected up to 3 mL of reconstituted PLA into the treatment area.10 Patients in the delayed group commenced treatment 12 weeks after those in the immediate group.10
The researchers showed PLA has a favorable long-term safety and efficacy profile, with no serious or severe side effects reported in 2 years.10 Significant improvements in Visual Analogue Scores from baseline were noted as well as a trend for improvements in Hospital Anxiety and Depression Scale scores.10 The positive results of PLA treatment achieved at week 24 were maintained to the recall visit, up to 2 years after treatment initiation.10
A second study investigated the use of PLA in patients with all four grades of lipoatrophy.11 The distribution of severity among patients was Stage I (N=9); Stage II (N=15); Stage III (N=30); and Stage IV (N=7).11 After the initial treatment, 100% of patients noted at least a slight improvement of facial concavities (Grade 3, or ‘‘Fair’’).11 In all cases, the patient rated his appearance higher than the physicians, even when the physicians noted no change.11
A review of how Sculptra is used for the treatment of HIV-associated facial lipodystrophy reports the resulting change in skin thickness may persist from baseline for up to 2 years.12
Radiesse
Radiesse, a semi-solid cohesive implant of synthetic calcium hydroxylapatite suspended in a gel carrier, was approved by the FDA for HIV-associated facial lipoatrophy in 2006.13 The approval study involved a mean initial treatment volume of 4.8 mL and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month).13 At 6 months, the mean touch-up volume was 2.4 mL for almost 90% (89%) of patients.13 The majority of patients (78%) received a total of three treatments, while 4% received only one treatment and 18% had two treatments.13 No patient received more than three treatments.13
Treatment with Radiesse resulted in sustainable improvements in cheek thickness.13 At baseline, mean thickness of the left cheek was 4.7 mm (N=100).13 At 3 months, mean thickness of the left check was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline (P=0.0001).13 At 6 months, the mean thickness of the left cheek was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline (P=0.0001).13 For the right cheek, mean cheek thickness at baseline was 4.9 mm (N=100).13 At 3 months, mean thickness of the right cheek was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline (P=0.0001). At 6 months, the mean thickness of the right cheek was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline (P=0.0001).13
Other studies support the use of Radiesse for this indication. One investigation found that mean cheek thickness improved over 12 months, with the greatest improvement after 3 months.14 At all three points of measurement, the changes from baseline were highly statistically significant.14 In addition, 100% of patients reported satisfaction on all measurements of patient satisfaction at all time periods measured (3, 6 and 12 months).14
Generally, Radiesse results in sustained improvement through 12 months.15
The Effect of Treatment on Quality of Life
The negative impact of HIV-associated facial lipoatrophy is well documented in the literature and through the anecdotal experience of physicians. Lipodystrophy can inadvertently disclose an individual’s HIV status if the person lives in a community where lipodystrophy is well understood, such as a large city like San Francisco or New York, or where there are large populations of high-risk groups, particularly men who have sex with men. This change in facial structure can affect social and personal relationships, mood and quality of life and one’s ability to work.3,4,15 The condition can also negatively impact an individual’s adherence to HAART.3,15,16
“It’s one thing for society to care about people’s survival, but you have to care about their quality of life,” Dr. Conant says. “It’s not just enough to breathe in and out every day. It’s can you have friends, can you go out, can you be seen in public? It’s just as important. We, as a culture, have provided Social Security and other benefit programs for patients, but, unfortunately, we have not taken the steps necessary to provide for their quality of care. It’s the same as a woman who has had a breast removed – she’s going to want an implant. Someone who’s lost their face because of the disease – because of treatment for the disease – is going to want some sort of corrective procedure so they can live normally.”
The ability to use dermal fillers has significantly improved the appearance of this condition and, therefore, improved quality of life for these patients, Dr. Conant continues.
Dr. Cohen concurs.
“These patients are living longer, they’re much healthier, they actually look good – they don’t look like they have HIV and are on HAART therapy, and they don’t require as many treatments,” he says. “It’s something that I really enjoy doing. My staff knows this is an important part of my day when I see patients with this, and I can really help them through the stigma of appearing sick when they don’t feel sick anymore.”
Figure 1: Before (left) and after (right) photos of a patient injected with 2.6 cc of Radiesse for HIV-associated lipodystrophy. The follow-up photo was taken 2 weeks after the injection.
Photos courtesy of Joel Cohen, MD, FAAD
Editor's Note: Please click on each image to see the full-size version.
Two of Dr. Cohen’s patients described the impact that treatment for lipoatrophy has had on their quality of life.
Scott
Scott was diagnosed as HIV-positive in 1987, and he participated in many different case studies for any new drug that was introduced. He started to notice a gradual volume loss that quickly became apparent.
“I grew up as a speed skater to begin with, so I was very fit,” Scott says. “That only made it worse. Mainly, it was around the nose and mouth that looked really sunken in. You just look 20 years older. I would say, by the year 2000 or so, I was like, ‘Okay, what can I do?’”
Scott’s decision to seek treatment for his facial lipodystrophy coincided with his occupational move into education.
“You could look at people and you could tell,” Scott explains. “By the time the lipoatrophy started, I had moved into education, as a teacher and as a principal of an elementary school. Especially in the gay community, and even outside of there, you could tell who had [HIV] and who didn’t, just by the appearance of their face. I didn’t want to be seen that way.”
The treatment was life changing, Scott says, who discussed the impact of his improved facial appearance in relation to his HIV infection.
“I went from 53 T cells at one point to an undetectable viral load now,” Scott says. “There’s been a lot of lows in there, but you can’t go by your lows, necessarily. I think the mental aspect of it – and the way you look – and I’m not a person who’s over the top or anything like that, but I’m very athletic – is huge. As someone who once had a terminal disease, [the filler treatment] definitely makes you feel like a person again."
Richard
“I was diagnosed HIV positive in 1984,” Richard explains. “I started drug therapy as soon as there were drugs available. At first, there wasn’t anything – they just expected you to die within 6 months and told you to go home and get your affairs in order. I’ve been on any number of regimens for the past almost 30 years.”
Richard says it was about 10 years ago that he first started noticing the facial volume loss. He noticed the issue around the same time he was recovering from chemotherapy for rectal cancer, once he had started going back to the gym and working with a nutritionist and a personal trainer.
“My body looked great, but my face – I’d look in the mirror and think, ‘Oh, god, I have the AIDS face,’” Richard explains. “I don’t know if the general population is aware of the AIDS face, but anyone who has gay friends or who has been in the community – they know the look, the AIDS face. You [can] look at a room full of men and pick out the ones who are probably HIV-positive.”
A friend of Richard’s who is also HIV-positive told him about the filler treatment he had been receiving, which prompted Richard to see Dr. Cohen.
“It’s really hard to describe, emotionally, how [the filler treatment] makes you feel about yourself,” Richard explains. “It helps to improve your self-worth and your self-image. You wouldn’t think that a little bit of injecting someone could have that type of effect, but it’s on your face. Your whole outlook on life – when you don’t even feel like leaving the house – changes… It’s hard to really, unless you’re in our shoes and inside our brains, understand that this has a huge impact on your life and your whole outlook and how you feel about yourself and how you want to go out and interact with other people.”
Richard also reflected on the impact of the filler treatments in regard to the span of his HIV infection.
“We spent thousands of dollars on drugs and co-pays and doctor visits and tests,” he says. “Then we get to the point where they have these really great drugs out there that are going to keep us all alive, so you can continue to work and be a productive member of society and not be on disability and build your life and resume saving for retirement – because now you may live until retirement – and you look in the mirror and it’s like, ‘Oh god, everything’s good but this’ – but now there’s fillers to help with that.”
SIDEBAR: The Affordability of Dermal Fillers for HIV-Associated Lipoatrophy
The positive impact that filler treatments can have for patients with HIV-associated lipoatrophy is significant. However, the cost can be significant as well. According to Dr. Beer, Sculptra costs between $2,500 and $5,000, depending on how many bottles are required for treatment. He estimates each bottle costs about $800.
“Radiesse is a little more complicated,” Dr. Beer continues. “It comes in various size syringes, including 0.3 mL, 0.8 mL and 1.5 mL. Many places will advertise injections for $500 and then use a small syringe. I would estimate that most injectors who are experienced charge $800 or so for the 1.5 mL syringe, $500 for the 0.8 mL syringe and $350 for the 0.3 mL syringe.”
As a result, access to these treatments can be complicated by how expensive the treatments are, Dr. Conant explains.
“Some insurance companies, including Medicare, do offer payment for the procedure, but the amount they offer is not enough to encourage most providers to give it,” he continues.
According to information from the Centers for Medicare & Medicaid Services published in 2010, “Dermal injections for facial lipodystrophy syndrome are only reasonable and necessary using dermal fillers approved by the FDA for this purpose, and then only in HIV-infected beneficiaries who manifest depression secondary to the physical stigma of HIV treatment.”17
Patients can utilize programs to reduce the cost of this filler treatment. One example in the San Francisco Bay Area is Catholic Charities, according to Dr. Conant.
The makers of Sculptra and Radiesse both offer assistance programs to help patients pay for the treatment. The Radiesse Patient Access Program has specific patient qualifications, including income range, US citizenship status and more.18 Sculptra also offers a patient access program that helps patients afford the injections; as with Radiesse, there are patient eligibility requirements in order to receive Sculptra at reduced or no cost.19
For both Scott and Richard, the treatments are worth the expense.
“The biggest thing for me – and I can say this because I have friends that I’ve referred – is that, once you realize you can get that look back and not have these facial features – you will maintain it and do whatever you can, even in hard economic times, because, for your own self-esteem and reapplying for jobs now, it’s very important to look as good as you can and as healthy as you can,” Scott says.
Richard concurs.
“It’s a very expensive procedure,” Richard explains. “It’s unfortunate. It’s sort of in my yearly budget to allocate so much money for treatment. Now, I’m to the point where I usually go in once a year for what I call a tune-up. Before, I was going every 6 months, but I was making a lot more money than I am now. It was easier to afford. It’s worth the money, because it makes you feel better about yourself and how you look, and you can’t put a price on that.”
Be sure to read Part 1: Dermatologic Management of Patients with HIV/AIDS, Part 1: Cutaneous Manifestations and Complications.
References
1. AIDS.gov. Chronic manageable disease. https://1.usa.gov/10h68VS. Accessed May 20, 2013.
2. UNAIDS.gov. The HIV experience and other chronic diseases. https://bit.ly/OWu61H. Accessed May 20, 2013.
3. Moyle GJ. Cosmetic interventions for HIV-associated lipoatrophy. Medscape Education. www.medscape.org/viewarticle/548185. Published November 30, 2006. Accessed May 20, 2013.
4. Hornberger J, Rajagopalan R, Shewade A, Loutfy MR. Cost consequences of HIV-associated lipoatrophy. AIDS Care. 2009;21(5):664-671.
5. Bugge H, Negaard A, Skeie L, Bergersen B. Hyaluronic acid treatment of facial fat atrophy in HIV-positive patients. HIV Med. 2007;8(8):475-482.
6. Schweiger ES, Riddle CC, Wernli BJ, Tonkovic-Capin V. Comparison of poly-L-lactic acid and calcium hydroxylapatite for treating human immunodeficiency virus-associated facial lipoatrophy. Cosmet Dermatol. 2007;20(5):304-312.
7. James J, Carruthers A, Carruthers J. HIV-associated facial lipoatrophy. Dermatol Surg. 2002;28(11):979-986.
8. Hansen AB, Lindegaard B, Obel N, Andersen O, Nielsen H, Gerstoft J. Pronounced lipoatrophy in HIV-infected men receiving HAART for more than 6 years compared with the background population. HIV Med. 2006;7(1):38-45.
9. FDA. FDA approval of Sculptra for treating facial lipoatrophy. https://1.usa.gov/18icKVZ. Accessed May 22, 2013.
10. Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-associated facial lipoatrophy. HIV Med. 2006;7(3):181-185.
11. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52(2):233-239.
12. Dinman S. Sculptra use in HIV-associated lipodystrophy. Plast Surg Nurs. 2008;28(1):53-54.
13. FDA. FDA approves Radiesse for treating facial lipoatrophy. https://1.usa.gov/YZNZLv. Accessed May 22, 2013.
14. Carruthers A, Carruthers J. Evaluation of injectable calcium hydroxylapatite for the treatment of facial lipoatrophy associated with human immunodeficiency virus. Dermatol Surg. 2008;34(11):1486-1499.
15. UpToDate. Treatment of HIV-associated lipoatrophy. https://nihlibrary.ors.nih.gov/jw/POC/UHIVlipids.htm. Accessed May 22, 2013.
16. Serra MS, Oyafuso LK, Trope BM, Munhoz Leite M, Ramos-e-Silva M. An index for staging facial lipoatrophy and evaluation of the efficacy of the treatment with polymethylmethacrylate in HIV/AIDS patients: A pilot study. J Eur Acad Dermatol Venereol. Published online ahead of print July 9, 2012.
17. MLN Matters. Dermal injections for treatment of facial lipodystrophy syndrome (LDS). https://go.cms.gov/18iJmPc. Accessed May 22, 2013.
18. Radiesse. How much does it cost? www.radiesse-fl.com/What-is-Radiesse/How-much-does-it-cost/. Accessed May 22, 2013.
19. TheBody.com. Forum on facial wasting. Radiesse/Sculptra patient assistance programs. https://bit.ly/11vhPd4. Accessed May 28, 2013.
The second and final part of this series focuses on the development of HIV-associated facial lipoatrophy, a condition dermatologists can treat with injectable fillers.
Highly active antiretroviral therapy (HAART) has had a very significant impact on the long-term survival of patients with HIV/AIDS. For patients who adhere to drug regimens and engage in additional healthy lifestyle practices, HIV infection can now be managed as a chronic disease.1,2
However, in the scope of the dermatologic management of HIV/AIDS, the long-term survival of these patients has introduced a new issue: lipoatrophy. Lipoatrophy, the localized loss of fat tissue, is one aspect of the larger lipodystrophy syndrome. The terms lipoatrophy and lipodystrophy can be – and are – used interchangeably, explains Dr. Marcus Conant, a dermatologist in San Francisco who was one of the first physicians to identify the symptoms of HIV and diagnose and treat AIDS patients in the early 1980s. He started seeing some of the first cases of lipodystrophy in HIV-positive patients around 1999.
“Lipoatrophy is the loss of fat,” Dr. Conant explains. “Lipodystrophy means the abnormal disposal of fat. Lipoatrophy of the face – or lipodystrophy of the face – means wasting in the face. The lipodystrophy syndrome includes facial wasting, buffalo hump (when the fat pad in the back of the neck becomes enlarged), abdominal obesity and swelling or increased fat in the mons pubis, right above the pubic bone. And there’s peripheral wasting – the loss of fat in the arms and legs. [HIV patients] also get insulin-resistant diabetes. All of that is the lipodystrophy syndrome. Patients come to dermatologists for the lipoatrophy of the face part of that syndrome.”
Lipoatrophy of the face in HIV-positive patients is associated with a negative impact on control of HIV disease and quality of life.3-5 Patients who experience lipoatrophy describe the volume loss as highly stigmatizing, and it can lead to depression, occupational issues and social isolation.3,4 However, the use of deep fillers has become an effective strategy dermatologists can offer HIV-positive patients who suffer from lipoatrophy.6
This article will review the development of lipoatrophy in HIV-positive patients, the potential mechanisms behind it and the treatment options dermatologists can offer patients to correct facial wasting. The impact of successful treatment for HIV-associated lipoatrophy of the face will also be explored.
Progression of HIV-Associated Lipoatrophy
Reports of lipoatrophy in HIV-positive patients began surfacing in the literature around the same time as the introduction of protease inhibitors, a class of drugs that are seen as a major advancement in the treatment of HIV.7 Other classes of HAART have been associated with the development of lipoatrophy, including reverse-transcriptase inhibitors.8 However, it is not clear whether facial wasting is due to the drugs themselves, the underlying HIV infection or the two factors in combination.
“We don’t know what causes lipodystrophy,” Dr. Conant explains. “It may be the drugs, but there are other factors. The trouble is that the reports you see are a few case reports – you put the whole picture together, and you talk to people who have been seeing these patients as I have for years and years and years, and you say, yes, you’ve seen patients who have been on the protease inhibitors. But they were also on the other drugs. So then we wondered, well, maybe it’s not the drugs – maybe patients didn’t live long enough before to get lipodystrophy, and so, consequentially, the drugs are keeping them alive, so it’s a problem related to the underlying HIV infection that’s now presenting itself. So, there are two possibilities – one that it’s the drugs and two that it was the HIV infection itself coupled with the number of years of survival. So, at the present time, I think we have to say: It is unique to HIV-infected people on treatment and we do not know the cause.”
One study describes HIV-associated lipoatrophy as a condition with “multifactorial etiologies related to the type of antiretroviral therapy, HIV disease and host factors rather than one entity.”8
Treatment with Fillers
According to Dr. Conant, treatment of HIV-associated facial lipodystrophy requires a semi-permanent deep filler. The two products used most often are Sculptra (poly-L-lactic acid [PLA]) and Radiesse (calcium particles). Sculptra and Radiesse are the only fillers specifically approved by the FDA for the treatment of HIV-associated facial lipoatrophy.
“Sculptra has a long history of treating HIV-associated lipoatrophy and has worked well,” explains Kenneth Beer, MD, a dermatologist in private practice in West Palm Beach, FL and a director of the Cosmetic Bootcamp meeting. “Radiesse also has the ability to treat facial volume loss and may be used to treat HIV-associated lipoatrophy.”
The nature of the filler treatment will vary depending on the degree of the patient’s facial volume loss, explains Joel Cohen, MD, FAAD, director of AboutSkin Dermatology and DermSurgery in Denver, CO.
“Grade 1 is some soft tissue loss,” Dr. Cohen explains. “Grade 2 is moderate soft tissue loss. Grade 3 is significant, such that you’re starting to get skin with very little soft tissue, and then Grade 4 is just skin on bone – there’s nothing in that compartment.”
The Facial Lipoatrophy Severity Scale was published by James, Carruthers and Carruthers in 2002, where the four grades of HIV-associated lipoatrophy are explained in detail.7
Dr. Cohen has been treating patients with HIV-associated lipodystrophy for about 10 years, and he believes Sculptra and Radiesse offer distinct advantages for treating this condition.
“With Sculptra, you take someone who’s Grade 3 or 4 and you do a couple treatments and it’s gradual,” Dr. Cohen explains. “There are other people who, after you do something gradual like that, you can switch to something like Radiesse. With Radiesse, you put it in and it’s there [immediately]. So there are some patients who say, ‘Make this gradual, I don’t want this to be corrected overnight – it’s Friday and I don’t want to look like a different person on Monday.’ That’s great – you start with Sculptra and you do some sessions and then maybe you switch them over to Radiesse to put the finishing touches on it. Then there are other people who come in and say, ‘Look, I’m starting a new job, and I have this condition, and people don’t know what I look like, and so I just want to look better, and my new job starts in two weeks.’ So, with those people, I would go right to Radiesse.”
Artefill and silicone can also be used for HIV-associated facial lipoatrophy, according to Dr. Beer. Artefill is a long-lasting dermal filler composed of bovine collagen and polymethylmethacrylate microspheres. Silicone is polymers of dimethylsiloxane composed of elemental silicon, oxygen and methane subgroups.
“Artefill and silicone last forever, but, with the loss of additional volume, patients will need touch-ups,” Dr. Beer explains.
Efficacy and Duration of Various Fillers
Sculptra
Poly-L-lactic acid (Sculptra) was approved by the FDA for the treatment of HIV-associated facial lipodystrophy in 2004.9 The data from the four studies that led to the approval of PLA for this indication demonstrate the product significantly improves facial appearance and was safe for restoration and/or correction of shape and contour deficiencies resulting from facial fat loss in HIV/AIDS patients.9
“People who have severe lipoatrophy – which means that they’ve lost all of the fat – will require something in the range of 6 to 12 bottles of Sculptra to correct the problem,” Dr. Conant explains. “People who have minor lipoatrophy or who start the treatments earlier will require only two or three bottles of polylactic acid to correct it. The polylactic acid will last a variable period of time. For most patients, they get good results for a year, year and a half. For many patients, especially those who have severe lipoatrophy, they begin to notice that they’re losing [the volume restoration] as early as 6 months.”
Studies investigating the use of PLA for HIV-associated facial lipoatrophy speak to the treatment’s efficacy for this indication.
In one study, participants received three treatment sessions, separated by fortnightly intervals, of bilateral injections of PLA into the deep dermis overlying the buccal fat pads.10 For each treatment, 0.15 g of PLA was reconstituted with 2 mL of sterile water for injection and 1 mL of 2% lidocaine for a total volume of 3 mL.10 The researchers injected up to 3 mL of reconstituted PLA into the treatment area.10 Patients in the delayed group commenced treatment 12 weeks after those in the immediate group.10
The researchers showed PLA has a favorable long-term safety and efficacy profile, with no serious or severe side effects reported in 2 years.10 Significant improvements in Visual Analogue Scores from baseline were noted as well as a trend for improvements in Hospital Anxiety and Depression Scale scores.10 The positive results of PLA treatment achieved at week 24 were maintained to the recall visit, up to 2 years after treatment initiation.10
A second study investigated the use of PLA in patients with all four grades of lipoatrophy.11 The distribution of severity among patients was Stage I (N=9); Stage II (N=15); Stage III (N=30); and Stage IV (N=7).11 After the initial treatment, 100% of patients noted at least a slight improvement of facial concavities (Grade 3, or ‘‘Fair’’).11 In all cases, the patient rated his appearance higher than the physicians, even when the physicians noted no change.11
A review of how Sculptra is used for the treatment of HIV-associated facial lipodystrophy reports the resulting change in skin thickness may persist from baseline for up to 2 years.12
Radiesse
Radiesse, a semi-solid cohesive implant of synthetic calcium hydroxylapatite suspended in a gel carrier, was approved by the FDA for HIV-associated facial lipoatrophy in 2006.13 The approval study involved a mean initial treatment volume of 4.8 mL and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month).13 At 6 months, the mean touch-up volume was 2.4 mL for almost 90% (89%) of patients.13 The majority of patients (78%) received a total of three treatments, while 4% received only one treatment and 18% had two treatments.13 No patient received more than three treatments.13
Treatment with Radiesse resulted in sustainable improvements in cheek thickness.13 At baseline, mean thickness of the left cheek was 4.7 mm (N=100).13 At 3 months, mean thickness of the left check was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline (P=0.0001).13 At 6 months, the mean thickness of the left cheek was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline (P=0.0001).13 For the right cheek, mean cheek thickness at baseline was 4.9 mm (N=100).13 At 3 months, mean thickness of the right cheek was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline (P=0.0001). At 6 months, the mean thickness of the right cheek was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline (P=0.0001).13
Other studies support the use of Radiesse for this indication. One investigation found that mean cheek thickness improved over 12 months, with the greatest improvement after 3 months.14 At all three points of measurement, the changes from baseline were highly statistically significant.14 In addition, 100% of patients reported satisfaction on all measurements of patient satisfaction at all time periods measured (3, 6 and 12 months).14
Generally, Radiesse results in sustained improvement through 12 months.15
The Effect of Treatment on Quality of Life
The negative impact of HIV-associated facial lipoatrophy is well documented in the literature and through the anecdotal experience of physicians. Lipodystrophy can inadvertently disclose an individual’s HIV status if the person lives in a community where lipodystrophy is well understood, such as a large city like San Francisco or New York, or where there are large populations of high-risk groups, particularly men who have sex with men. This change in facial structure can affect social and personal relationships, mood and quality of life and one’s ability to work.3,4,15 The condition can also negatively impact an individual’s adherence to HAART.3,15,16
“It’s one thing for society to care about people’s survival, but you have to care about their quality of life,” Dr. Conant says. “It’s not just enough to breathe in and out every day. It’s can you have friends, can you go out, can you be seen in public? It’s just as important. We, as a culture, have provided Social Security and other benefit programs for patients, but, unfortunately, we have not taken the steps necessary to provide for their quality of care. It’s the same as a woman who has had a breast removed – she’s going to want an implant. Someone who’s lost their face because of the disease – because of treatment for the disease – is going to want some sort of corrective procedure so they can live normally.”
The ability to use dermal fillers has significantly improved the appearance of this condition and, therefore, improved quality of life for these patients, Dr. Conant continues.
Dr. Cohen concurs.
“These patients are living longer, they’re much healthier, they actually look good – they don’t look like they have HIV and are on HAART therapy, and they don’t require as many treatments,” he says. “It’s something that I really enjoy doing. My staff knows this is an important part of my day when I see patients with this, and I can really help them through the stigma of appearing sick when they don’t feel sick anymore.”
Figure 1: Before (left) and after (right) photos of a patient injected with 2.6 cc of Radiesse for HIV-associated lipodystrophy. The follow-up photo was taken 2 weeks after the injection.
Photos courtesy of Joel Cohen, MD, FAAD
Editor's Note: Please click on each image to see the full-size version.
Two of Dr. Cohen’s patients described the impact that treatment for lipoatrophy has had on their quality of life.
Scott
Scott was diagnosed as HIV-positive in 1987, and he participated in many different case studies for any new drug that was introduced. He started to notice a gradual volume loss that quickly became apparent.
“I grew up as a speed skater to begin with, so I was very fit,” Scott says. “That only made it worse. Mainly, it was around the nose and mouth that looked really sunken in. You just look 20 years older. I would say, by the year 2000 or so, I was like, ‘Okay, what can I do?’”
Scott’s decision to seek treatment for his facial lipodystrophy coincided with his occupational move into education.
“You could look at people and you could tell,” Scott explains. “By the time the lipoatrophy started, I had moved into education, as a teacher and as a principal of an elementary school. Especially in the gay community, and even outside of there, you could tell who had [HIV] and who didn’t, just by the appearance of their face. I didn’t want to be seen that way.”
The treatment was life changing, Scott says, who discussed the impact of his improved facial appearance in relation to his HIV infection.
“I went from 53 T cells at one point to an undetectable viral load now,” Scott says. “There’s been a lot of lows in there, but you can’t go by your lows, necessarily. I think the mental aspect of it – and the way you look – and I’m not a person who’s over the top or anything like that, but I’m very athletic – is huge. As someone who once had a terminal disease, [the filler treatment] definitely makes you feel like a person again."
Richard
“I was diagnosed HIV positive in 1984,” Richard explains. “I started drug therapy as soon as there were drugs available. At first, there wasn’t anything – they just expected you to die within 6 months and told you to go home and get your affairs in order. I’ve been on any number of regimens for the past almost 30 years.”
Richard says it was about 10 years ago that he first started noticing the facial volume loss. He noticed the issue around the same time he was recovering from chemotherapy for rectal cancer, once he had started going back to the gym and working with a nutritionist and a personal trainer.
“My body looked great, but my face – I’d look in the mirror and think, ‘Oh, god, I have the AIDS face,’” Richard explains. “I don’t know if the general population is aware of the AIDS face, but anyone who has gay friends or who has been in the community – they know the look, the AIDS face. You [can] look at a room full of men and pick out the ones who are probably HIV-positive.”
A friend of Richard’s who is also HIV-positive told him about the filler treatment he had been receiving, which prompted Richard to see Dr. Cohen.
“It’s really hard to describe, emotionally, how [the filler treatment] makes you feel about yourself,” Richard explains. “It helps to improve your self-worth and your self-image. You wouldn’t think that a little bit of injecting someone could have that type of effect, but it’s on your face. Your whole outlook on life – when you don’t even feel like leaving the house – changes… It’s hard to really, unless you’re in our shoes and inside our brains, understand that this has a huge impact on your life and your whole outlook and how you feel about yourself and how you want to go out and interact with other people.”
Richard also reflected on the impact of the filler treatments in regard to the span of his HIV infection.
“We spent thousands of dollars on drugs and co-pays and doctor visits and tests,” he says. “Then we get to the point where they have these really great drugs out there that are going to keep us all alive, so you can continue to work and be a productive member of society and not be on disability and build your life and resume saving for retirement – because now you may live until retirement – and you look in the mirror and it’s like, ‘Oh god, everything’s good but this’ – but now there’s fillers to help with that.”
SIDEBAR: The Affordability of Dermal Fillers for HIV-Associated Lipoatrophy
The positive impact that filler treatments can have for patients with HIV-associated lipoatrophy is significant. However, the cost can be significant as well. According to Dr. Beer, Sculptra costs between $2,500 and $5,000, depending on how many bottles are required for treatment. He estimates each bottle costs about $800.
“Radiesse is a little more complicated,” Dr. Beer continues. “It comes in various size syringes, including 0.3 mL, 0.8 mL and 1.5 mL. Many places will advertise injections for $500 and then use a small syringe. I would estimate that most injectors who are experienced charge $800 or so for the 1.5 mL syringe, $500 for the 0.8 mL syringe and $350 for the 0.3 mL syringe.”
As a result, access to these treatments can be complicated by how expensive the treatments are, Dr. Conant explains.
“Some insurance companies, including Medicare, do offer payment for the procedure, but the amount they offer is not enough to encourage most providers to give it,” he continues.
According to information from the Centers for Medicare & Medicaid Services published in 2010, “Dermal injections for facial lipodystrophy syndrome are only reasonable and necessary using dermal fillers approved by the FDA for this purpose, and then only in HIV-infected beneficiaries who manifest depression secondary to the physical stigma of HIV treatment.”17
Patients can utilize programs to reduce the cost of this filler treatment. One example in the San Francisco Bay Area is Catholic Charities, according to Dr. Conant.
The makers of Sculptra and Radiesse both offer assistance programs to help patients pay for the treatment. The Radiesse Patient Access Program has specific patient qualifications, including income range, US citizenship status and more.18 Sculptra also offers a patient access program that helps patients afford the injections; as with Radiesse, there are patient eligibility requirements in order to receive Sculptra at reduced or no cost.19
For both Scott and Richard, the treatments are worth the expense.
“The biggest thing for me – and I can say this because I have friends that I’ve referred – is that, once you realize you can get that look back and not have these facial features – you will maintain it and do whatever you can, even in hard economic times, because, for your own self-esteem and reapplying for jobs now, it’s very important to look as good as you can and as healthy as you can,” Scott says.
Richard concurs.
“It’s a very expensive procedure,” Richard explains. “It’s unfortunate. It’s sort of in my yearly budget to allocate so much money for treatment. Now, I’m to the point where I usually go in once a year for what I call a tune-up. Before, I was going every 6 months, but I was making a lot more money than I am now. It was easier to afford. It’s worth the money, because it makes you feel better about yourself and how you look, and you can’t put a price on that.”
Be sure to read Part 1: Dermatologic Management of Patients with HIV/AIDS, Part 1: Cutaneous Manifestations and Complications.
References
1. AIDS.gov. Chronic manageable disease. https://1.usa.gov/10h68VS. Accessed May 20, 2013.
2. UNAIDS.gov. The HIV experience and other chronic diseases. https://bit.ly/OWu61H. Accessed May 20, 2013.
3. Moyle GJ. Cosmetic interventions for HIV-associated lipoatrophy. Medscape Education. www.medscape.org/viewarticle/548185. Published November 30, 2006. Accessed May 20, 2013.
4. Hornberger J, Rajagopalan R, Shewade A, Loutfy MR. Cost consequences of HIV-associated lipoatrophy. AIDS Care. 2009;21(5):664-671.
5. Bugge H, Negaard A, Skeie L, Bergersen B. Hyaluronic acid treatment of facial fat atrophy in HIV-positive patients. HIV Med. 2007;8(8):475-482.
6. Schweiger ES, Riddle CC, Wernli BJ, Tonkovic-Capin V. Comparison of poly-L-lactic acid and calcium hydroxylapatite for treating human immunodeficiency virus-associated facial lipoatrophy. Cosmet Dermatol. 2007;20(5):304-312.
7. James J, Carruthers A, Carruthers J. HIV-associated facial lipoatrophy. Dermatol Surg. 2002;28(11):979-986.
8. Hansen AB, Lindegaard B, Obel N, Andersen O, Nielsen H, Gerstoft J. Pronounced lipoatrophy in HIV-infected men receiving HAART for more than 6 years compared with the background population. HIV Med. 2006;7(1):38-45.
9. FDA. FDA approval of Sculptra for treating facial lipoatrophy. https://1.usa.gov/18icKVZ. Accessed May 22, 2013.
10. Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-associated facial lipoatrophy. HIV Med. 2006;7(3):181-185.
11. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52(2):233-239.
12. Dinman S. Sculptra use in HIV-associated lipodystrophy. Plast Surg Nurs. 2008;28(1):53-54.
13. FDA. FDA approves Radiesse for treating facial lipoatrophy. https://1.usa.gov/YZNZLv. Accessed May 22, 2013.
14. Carruthers A, Carruthers J. Evaluation of injectable calcium hydroxylapatite for the treatment of facial lipoatrophy associated with human immunodeficiency virus. Dermatol Surg. 2008;34(11):1486-1499.
15. UpToDate. Treatment of HIV-associated lipoatrophy. https://nihlibrary.ors.nih.gov/jw/POC/UHIVlipids.htm. Accessed May 22, 2013.
16. Serra MS, Oyafuso LK, Trope BM, Munhoz Leite M, Ramos-e-Silva M. An index for staging facial lipoatrophy and evaluation of the efficacy of the treatment with polymethylmethacrylate in HIV/AIDS patients: A pilot study. J Eur Acad Dermatol Venereol. Published online ahead of print July 9, 2012.
17. MLN Matters. Dermal injections for treatment of facial lipodystrophy syndrome (LDS). https://go.cms.gov/18iJmPc. Accessed May 22, 2013.
18. Radiesse. How much does it cost? www.radiesse-fl.com/What-is-Radiesse/How-much-does-it-cost/. Accessed May 22, 2013.
19. TheBody.com. Forum on facial wasting. Radiesse/Sculptra patient assistance programs. https://bit.ly/11vhPd4. Accessed May 28, 2013.
Highly active antiretroviral therapy (HAART) has had a very significant impact on the long-term survival of patients with HIV/AIDS. For patients who adhere to drug regimens and engage in additional healthy lifestyle practices, HIV infection can now be managed as a chronic disease.1,2
