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Four-Year Follow-Up of Polyalkylimide Gel Use for the Treatment of HIV-Associated Lipoatrophy
January 2012
Mona R. Loutfy,1,2,3 Jason Brunetta,1 Colin Kovacs,1,2 Christina Diong,4 Molly Gamble,1
Tony Antoniou,1,5 Graham Smith,1 Roberta Halpenny,1 Ron Rosenes,6 and Janet M. Raboud2,4
1Maple Leaf Medical Clinic, Toronto; 2Department of Medicine, University of Toronto, Toronto; 3Department of Medicine,
Women's College Hospital, Toronto; 4Division of Infectious Diseases, University Health Network, Toronto; 5Department
of Family Practice, St. Michael's Hospital, Toronto; 6Canadian Treatment Action Council, Toronto, Ontario, Canada
Purpose: To evaluate polyalkylamide gel (PAIG) use in treating HIV-associated
facial lipoatrophy (FLA) 4 years after its injection in an open-label, randomized controlled
trial (RCT). Methods: Five patients were treated with PAIG in a pilot study,
and 31 patients were subsequently enrolled in the RCT of immediate or delayed
(12 weeks later) PAIG injections. Endpoints included proportion of participants with
complications; changes in FLA severity score (FLSS); and quality of life (QoL), depression,
anxiety, and satisfaction scores. Infections were classifi ed as "confi rmed" if
purulent material was extracted and/or an organism cultured. Infections were classifi
ed as "possible" if only clinical signs were present without purulent discharge or
microbiologic confi rmation. Results: Year 4 results were available for 5 pilot and
27 full-scale study participants. Delayed complications included 5 confi rmed infections
(15.6%), 3 possible infections (9.4%), nodules (25%), and bleeding (3%). No
signifi cant changes were observed between years 2 to 4 in patient-graded FLSS,
QoL, depression, and anxiety scores. Whereas 94% of participants were satisfi ed
with their overall treatment, only 69% were satisfi ed with PAIG treatment specifi cally.
Conclusion: Even though PAIG treatment was associated with delayed complications
including high rates of infection and nodules, most patients were satisfi ed with
the treatment. Key words: Bio-Alcamid, delayed adverse events, facial lipoatrophy,
HIV, infection, polyalkylimide gel
Facial lipoatrophy (FLA) remains one of the
most distressing complications of antiretroviral
therapy (ART) for patients infected
with HIV.1-3 The iatrogenic depletion in facial fat
can be highly stigmatizing for patients, can lead
to poor self-esteem and depression, and may
subsequently negatively affect ART adherence.1-4
Because effective medical therapies for reversing
FLA have been lacking, emphasis has been
placed on correction of FLA using facial fi llers.5-7
The 2 most commonly used facial fi llers for the
treatment of HIV-associated FLA are poly-L-lactic
acid (PLA) (New-Fill; Biotech Industry SA, Luxembourg)
8,9 and polyalkylimide gel (PAIG) (Bio-
Alcamid; Polymekon, Biotech Industrie, Milan,
Italy).10-12 PAIG possesses several properties that
may be advantageous relative to other products,
including the requirement of only a single course of
treatment; PAIG yields results that are permanent,
but removal is easy should such need subsequently
arise.13 It is a nonbiodegradable, nonallergenic, nontoxic polymer composed of 96% nonpyrogenic
water and 4% polyalkylimide. To date, it has been
shown to be safe and effective in the treatment of
HIV-associated FLA.10,11,13
We previously reported the week 48 and 96 results
of a randomized, open-label study of PAIG for the
correction of FLA in 31 HIV-positive patients.14,15
The results of the study demonstrated that treatment
with PAIG was safe and effective at both time
points, resulting in sustained reductions in the
severity of FLA and improvements in patient QoL, anxiety, and depression scores that were measured
using validated instruments.14,15 However, publication
of several cases of delayed adverse events associated
with PAIG have called the long-term safety of
this product into question.16-28 Most notably, several
centers have described infectious complications
such as cellulitis and abscess formation following
the prolonged use of PAIG for HIV-associated
FLA.16-29 Given the ramifi cations of delayed infectious
complications on the sustained use of PAIG,
we sought to explore the occurrence of such events
in a group of treated patients who participated in a
randomized controlled trial (RCT). In this report, we
present the 4-year follow-up data of the 31 patients
enrolled in the open-label RCT, along with 5 patients
who were previously enrolled in a pilot study.30
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Address for correspondence: Dr. Mona Loutfy, Women's College
Research Institute, Women's College Hospital, 790 Bay Street,
Room 736, Toronto, Ontario M5G 2N8 Canada; phone: 416-
351-3732 ext. 2324; fax: 416-351-3746; e-mail: mona.loutfy@
wchospital.ca
HIV Clin Trials 2011;12(6):323-332
© 2011 Thomas Land Publishers, Inc.
www.thomasland.com
doi: 10.1310/hct1206-323
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