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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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