Title: Restorative Treatment of HIV-associated Facial Lipoatrophy
Authors: Joseph A. Eviatar, MD, Stacey L. Silvers, MD, and Michael I. Echavez, MD
With the introduction of highly active antiretroviral therapy (HAART) in the mid to late 1990s,
HIV treatment providers have witnessed a shift in treatment regimen resulting in improved
prognoses. 1, 2 HAART has led to dramatic reductions in deaths associated with advanced HIV
disease. At the same time, however, noticeable changes in body fat and metabolic disturbances
have been observed in many HAART patients living with HIV.3
One area of particular concern is HIV-associated facial lipoatrophy.4 In this study, we assessed
the safety and effectiveness of Radiesse™ injections for the restorative treatment of HIVassociated facial lipoatrophy. Radiesse is a soft tissue augmentation material consisting of
microspheres of calcium hydroxylapatite in a carboxymethylcellulose gel carrier.
Method: One hundred (100) patients with HIV-associated facial lipoatrophy were enrolled into a
multicenter, open label FDA IDE trial between June and August 2004 at three centers (two in
New York, NY and one in San Francisco, CA). Subject inclusion criteria included a grade 2, 3 or 4
score on the Carruthers Facial Lipoatrophy Severity Scale.5 All patients had facial skin depth
measurements and photographs taken at baseline. All patients were seen at one-month following
the initial injection. Protocol allowed a touch up injection at this visit. A touch up injection was
performed if needed one month following the initial visit to obtain optimal correction. Follow up
visits were completed at three and six months, measured from the date of first treatment if no
touch up injection was performed, or from the date of the touch up injection if such was
performed. At each follow up visit subjects were scored on a facial global aesthetic improvement
rating (GAIS rating)6 and patient satisfaction was documented.
To inject the material for lipoatrophy augmentation, typically a 25-gauge, 1.5 inch needle was
used. The material was injected using a linear threading technique defined as depositing the filler
in a single strand. The number of linear threads of material deposited was at the discretion of the
treating physician and dependent upon the degree of facial lipoatrophy.
The average initial volume of product injected was 4.7 mL per patient. [Table 1] Eighty-five
percent of subjects received touch up injection with an average volume of 1.8 mL to achieve
optimal correction. [Table 2]
Results: Three months following the last injection, GAIS results were as follows: 26% Very much
improved, 72% Much improved and 2 % Improved (N=100). At six months, GAIS results were as
follows: 7% Very much improved, 86% Much improved and 7% Improved (N=98; two patients
died of conditions unrelated to study). [Table 3]. One hundred percent of patients were improved
at both the 3-month and 6-months visits, demonstrating that Radiesse is effective and durable as
a tissue augmentation material.
This study evaluated 100 patients treated with a total of more than 6 mL of Radiesse and followed
carefully for adverse events reporting. Adverse events were minor and included transient injection
site reactions, eg, erythema, swelling and itching. These events were generally of short duration
and did not require corrective treatment. There were no reported granulomas, no long-term
adverse events beyond the short term injection site reactions, and no reported serious adverse
events requiring further intervention due to the injections of Radiesse. No migration of Radiesse
was reported in this study.
Conclusions: The study demonstrated that 100% of patients had improved aesthetic outcomes
at six months follow up; more than 90% of patients were scored as Very Much Improved or Much
Improved on the GAIS rating scale. No granulomas or migration of material was observed in any
of the subjects. This study demonstrates the safety of a large volume of Radiesse injected into
the cheek of facial lipoatrophy patients. This study also demonstrates the durability of the
augmentation achieved with this new tissue augmentation material.
An optimal facial contouring material should have several properties. The material should provide
the patient with an immediate correction. It should provide durable, but preferably not permanent,
augmentation—and it should be safe for injection in large volumes. The current study indicates
that Radiesse provides the first available augmentation agent that meets these criteria.
Researchers concluded that Radiesse is a safe, effective and relatively long-lasting product for
facial soft tissue augmentation in patients with HIV-associated lipoatrophy. By three months, and
remaining at six months, the tissue forming in the cheek due to the Radiesse appeared soft to the
touch, with texture found in normal soft facial tissue. Its use clearly leads to noticeable
improvement in facial contours. As a consequence of this effect, its use also leads to a significant
improvement in the quality of life of patients living with HIV-associated lipoatrophy.
Table 1: Distribution of initial injection volume.
Total volume
% of Patients
(bilateral)
(n=100)
≤ 3.0 mL
23
3.1 – 5.0 mL
39
5.1 – 8.0 mL
36
 8.0 mL
2
Table 2: Distribution of touch up injection volume at one-month.
Total volume
% of Patients
(bilateral)
(n=100)
None
15
≤ 1.0 mL
36
≤ 2.0 mL
31
≤ 3.0 mL
8
 3.1 mL
10
Table 3: GAIS rating scores at three months and at six months follow up.
% of Patients
% of Patients
at 3 months follow up
at 6 months follow up
(n=100)
(n=98)
Very much improved
26
7
Much improved
72
86
Improved
2
7
No change
0
0
Worse
0
0
GAIS Rating
References
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