Long-term efficacy and safety of polyalkylimide gel for the treatment of HIV-associated lipoatrophy

Abstract

The long-term safety and efficacy of products used in the correction of HIV-associated facial lipoatrophy (FLA) are largely unknown. The purpose of this study was to describe the long-term efficacy and safety of polyalkylimide gel (PAIG) in the treatment of HIV-associated FLA. In this open-label, randomized, single-center study, 31 HIV-positive individuals (median age 48 years (interquartile ranges (IQR) 45, 55, 97% male) with FLA were randomized to immediate (week 0 and six) or delayed (week 12 and 18) PAIG injections. Week 96 endpoints included change in FLA severity scores (FLSS) (five-point scale), proportion of patients with adverse events, and changes in quality of life, depression and anxiety using validated surveys. Results at week 96 were available for 28 patients.

Adverse events, including swelling, redness, bruising and pain, were mild, and resolved after a median of three days following the injection. At week 96, median changes in physician and patient FLSS scores were −2 (IQR −3, −1; p<0.001 vs. baseline) and −2 (IQR −2, −1; p<0.001 vs. baseline), respectively. Physician and patient FLSS scores were not significantly different between the groups at week 96. Significant improvements in patient's anxiety (p<0.001), depression (p<0.001) and mental health (p=0.01) were observed from baseline to week 96. In conclusion, treatment with PAIG was associated with sustained improvements in both the physical and psychological components of FLA through 96 weeks of follow-up.

Keywords:

• Bio-Alcamid®
• facial lipoatrophy
• HIV
• polyalkylimide gel
• quality of life

Acknowledgements

We would like to thank the patients and research staff at the Maple Leaf Medical Clinic for their contribution to this work without whose help this research could not have been completed. We would like to thank John McCahill from PurMedical for providing Bio-Alcamid® free of charge for our study participants and for providing an unrestricted research grant for this study.

This project was funded by an unrestricted research grant from Pur Medical Corporation. In addition, a number of investigators are the recipients of salary support from the Canadian Institutes of Health Research (M. Loutfy), Ontario HIV Treatment Network (M. Loutfy, Janet M. Raboud) and the Skate the Dream Fund, University Health Network (Janet M. Raboud).