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Treatment
of Facial Lipoatrophy with Injections of Polylactic Acid (Sculptra/
New Fill)
By
Ronald Baker, PhD
Loss of fat in
the face (facial lipoatrophy)
is a constant reminder to affected HIV patients that they have a
devastating disease. The chief characteristics of facial lipoatrophy
are a sinking of the cheeks, eyes and temples. The effect
of lipoatrophy resembles that of AIDS-related wasting
and confers a very unwell appearance to many otherwise healthy HIV
positive individuals.
In many cases,
patients with facial lipoatrophy feel stigmatized and severely depressed.
In addition, this adverse effect of anti-HIV drug treatment may
lead to poor
adherence to antiretroviral therapy or to a rejection
of therapy altogether. The former can result in drug resistance
and treatment
failure and the latter in HIV
disease progression.
Unfortunately,
the cause(s) of lipoatrophy remain unclear and there is no known
preventive measure or treatment for the condition. Currently there
are only two temporarily successful interventions for facial lipoatrophy:
plastic surgery or the use of fillers. One of several filling components
available, polylactic
acid
(PLA) is called “New Fill” in Europe and “Sculptra”
in the US. (Dermik
Laboratories, Berwyn, PA, a division of Aventis, Strasbourg, France).
Following an expedited review, the US FDA approved Sculptra to correct
HIV-related facial lipoatrophy in August 2004.
Polylactic acid
is a biocompatible, biodegradable, and immunologically inert material
that has shown promise in several small studies in the US. Injections
of PLA are performed in the median-deep layer of the dermis, where
the material stimulates fibroblast multiplication and collagen production.
Published in the
current issue of JAIDS (April 1, 2005), the main objective
of the present prospective, open-label French study was to evaluate
the safety and efficacy of intradermal injections of PLA in the
treatment of facial lipoatrophy in 94 HIV-infected patients receiving
concurrent antiretroviral therapy. PLA was injected in both cheeks
of each patient every 2 weeks. The patients and the dermatologist
decided on the total number to injections to use, but based on earlier
experience and study results, it was thought that at least 3 sets
of injections were necessary to achieve the most benefits.
The primary efficacy
endpoint of the study was the patient's self-perception of improvement
as assessed by a visual analogue scale (VAS). Secondary endpoints
included 3-dimensional photographs (3DP) to measure dermal thickness,
quality of life (QoL) scores, and adverse events.
Results
Ninety-four patients received a median of 5 sets of injection
in both cheeks. Median age was 43 years, and median CD4 cell count
was 500 cells/microliter.
Median
VAS score significantly increased from 3.4/10 at baseline to 6.8/10
at the end of the treatment procedure and was sustained at 7/10
at the end of follow-up.
Median
dermal thickness increase was 2.3 mm at the end of follow-up.
QoL scores
remained unchanged.
Seventeen
patients needed further injections of PLA during a median follow-up
of 12 months.
Injections
were well tolerated with only one serious adverse event (anaphylactic
reaction) that necessitated treatment interruption.
Conclusions
The PLA injections
appear safe and they improved the study participant’s self-perception
of their facial lipoatrophy. The cosmetic improvement brought about
by the procedure, however, declined over time. Re-injections should
be considered by patients in about a year after their initial treatment.
Discussion
The mechanisms
of anti-HIV drug-associated lipodystrophy
in patients with HIV-infection remain poorly understood,
and therapeutic interventions such as changes in antiretroviral
therapy or use of the drug rosiglitazone have yielded inconsistent
and disappointing results, especially regarding the correction of
facial lipoatrophy. This explains why plastic surgery and cosmetic
therapy using filling components are still the preferred options
in the treatment of facial atrophy.
17/86 patients (19.5%) needed re-injections during follow-up.
The estimated probability of re-injection was 45% at 15 months.
“In conclusion,” write the authors, “our study confirmed that
the use of PLA injections in the treatment of facial lipoatrophy
is a safe procedure. Also, the benefit of this procedure as assessed
by patient self-perception of improvement (a subjective assessment)
persisted for up to 15 months beyond the last injection, a time
at which new injections might be necessary for up to 45% of the
patients.“
Further studies on the treatment of facial lipoatrophy with
PLA need to be conducted to address issues such as the number of
required injections, the volume of PLA to inject, the best interval
between injections and the long-term safety of the procedure.
Hôpital Saint-Louis, Paris, France.
03/21/05
Reference
M Lafaurie
and others. Treatment of Facial Lipoatrophy with Intradermal Injections
of Polylactic Acid. Journal
of Acquired Immune Deficiency Syndromes 38(4): 393-398. April 1, 2005.
Additional Articles on Facial Lipoatrophy
Poly-L-lactic
Acid Helps in HAART-related Facial Wasting
-
3/02/05
Studies
of Polylactic Acid Continue to Show Promise in Treatment of HIV-related
Facial Lipoatrophy
-
12/13/04
Custom-built
Implants Useful for Facial Wasting of HAART-related Lipodystrophy - 11/17/04
Highly
Purified Silicone Oil (Silskin) for Treatment of HIV-related Facial
Lipoatrophy: A Pilot Study - 10/15/04
Polymethylmethacrylate
(PMMA) for Facial Atrophy Treatment: 5 Years Follow-up - 07/12/04
Cosmetic
Filler Wins US Panel Support for HIV-related Lipoatrophy
-
3/29/04
Study
of Polylactic Acid Injections (PLA) for Cosmetic Management of
Facial Lipoatrophy -
3/15/04
Effects of Metformin or Gemfibrozil on HIV
Patients with Abdominal Obesity Receiving Protease Inhibitors
12/10/03
Facial
Implants for HIV and HAART-related Lipoatrophy: An Interview
with Dr. Gottfried Lemperle 11/19/03
Promising
Results from a Pilot Study of Polylactic Acid Implants (New-Fill)®
to Correct Facial Lipoatrophy in HIV Patients
11/12/03
Safely Treating Lipoatrophy Is
Major Concern for HIV Patients -
06/13/03
Pioglitazone Subjectively Improves Body Shape Abnormalities
-
04/03/03
Satellite
Meeting Addresses Cosmetic Approaches to Body Wasting
-
09/27/02
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