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Promising
Results from a Pilot Study of Polylactic Acid Implants (New-Fill)®
to Correct Facial Lipoatrophy in HIV Patients
By
Ronald Baker, PhD
Facial lipoatrophy (fat loss) associated with HIV and/or HAART can
be a devastating side effect for people living with HIV infection.
It often results in depression, significant loss of self-esteem
and a decline in quality of life.
Ironically, facial lipoatrophy is a frequent sign for HIV patients
receiving HAART that has resulted in low levels of HIV RNA and increased
CD4 counts. Sadly, some HIV patients who require therapy have delayed
or completely rejected it due to their concern for developing facial
lipoatrophy. Among other patients, it is a reason for non adherence
to therapy.
Because there is as yet no known therapy for managing facial atrophy
in HIV patients, various approaches for cosmetic treatment have
been utilized, including facial implants.
In 1999, regulators in the European Union approved poly-L-lactic
(PLA) New- Fill for cosmetic correction of scars and wrinkles. US
patients, with a physician's prescription, may import this product
for their own personal use under the supervision of a qualified
doctor.
New-Fill is a biocompatible and immunologically inert synthetic
polymer that belongs to the class of resorbable biomaterials. The
product has been safely used in a variety of orthopedic and maxillofacial
applications since the mid-1990s.
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Clinical
change after PLA injections between
baseline and week 96, after five and four sessions
of injections, for patient 1 and patient 2 respectively.
(a- d) Patient 1, at day 0 (a, c) and
week 96 (b, d).
(e-h) Patient 2, at day 0 (e, g) and week 96 |
Given widespread
patient and caregiver interest in the US and Europe in an intervention
for HIV and HAART-related facial atrophy, French researchers conducted
and open label pilot study to evaluate the effectiveness and safety
of injections with New-Fill in HIV positive patients with severe facial
lipoatrophy. Following is a summary of the results of that open label
study, published in the November 21, 2003 issue of AIDS:
50 patients received four sets of injection of New-Fill at day 0 and
then every 2 weeks for 6 weeks. Evaluation included clinical examination,
facial ultrasonography and photography at screening and at weeks 6,
24, 48, 72, and 96.
At entry, the median facial fat thickness was equal to zero (range,
0.0-2.1 mm). The median total cutaneous thickness (TCT) increased
significantly from baseline:
·
+5.1 mm (range,
2.2-8.6 mm) at week 6,
·
+6.4 mm (range,
3.1-9.1 mm) at week 24,
·
+7.2 mm (range, 4.2-9.6 mm) at week 48,
·
+7.2 mm (range,
3.5-9.6 mm) at week 72; and
·
+6.8 mm (range,
3.9-10.1 mm) at week 96 (P < 0.001).
The proportion
of patients with TCT > 10 mm was observed in 19% at week 6, 41%
at week 24, 61% at week 48, 52% at week 72 and 43% at week 96.
No serious adverse events were observed during the study, and no
patient interrupted PLA injections due to side effects. Minimal
and localized oedema at the injection site was seen in most patients,
which spontaneously resolved within 24-48 h. In 22 (44%) patients,
palpable but non-visible subcutaneous micronodules were observed
with a spontaneous resolution in six patients at week 96.
The authors
conclude, "The benefit of PLA for the correction of the facial
lipoatrophy in HIV-infected patients was clearly demonstrated, with
an evident aesthetic and quality of life improvement. The efficacy,
safety profile, and the simplicity of the injection schedule of
PLA make this filling material a potentially attractive treatment."
Note: The US Food and Drug Administration
(FDA) is expected to review New-Fill as a treatment for severe lipoatrophy
early in 2004.
11/12/03
Reference
M-A Valantin and others (for the VEGA study). Polylactic acid implants
(New-Fill)® to correct facial lipoatrophy in HIV-infected patients:
results of the open-label study VEGA. AIDS 2003; 17(17):
2471-2477. November 21, 2003.
[ See Also: HIV WASTING SECTION
]
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