Thirty-one participants were enrolled in the trial between April and July 2005. All but one were male; nearly all were white gay men. The median age was 48 years; all were currently on antiretroviral therapy and quite highly treatment-experienced, diagnosed a median of 16 years and on antiretrovirals of some kind a median of twelve years. Participants were evaluated using Carruther’s facial lipoatrophy severity score (FLSS), as gauged by three observing physicians and participant self-report. The FLSS ranges from 0 (for no lipoatrophy), 1 (for mild) to 4 (severe). At baseline, 23 participants (74%) had moderate to severe FL, with a median score of 2 (none had a zero score at baseline).
Participants were randomised to either receive PAIG injections immediately (at weeks 0 and 6: n=16) or at a later time point (weeks 12 and 18: n=15), and were followed for 48 weeks. Most participants (58%) required either one or two injections; the remainder received a total of three or four. The median volume of PAIG injected over the course of the study was 16.0 ml.
A small, open-label study has found that injections of polyalkylimide gel (Bio-Alcamid) safely and effectively reduced the visible symptoms of facial lipoatrophy in HIV-positive patients, and improved self-reported anxiety, depression and overall quality of life. The study, performed at a clinic in Toronto, was reported in the May 31st edition of AIDS.
Facial lipoatrophy (FL), the loss of subcutaneous facial fat, is not uncommon in individuals (particularly men) on antiretroviral therapy. FL is a distressing and stigmatising condition which affects self-esteem and may deter people from going onto antiretroviral treatment. Medical treatments for FL are very limited; the most effective treatments are forms of plastic surgery involving filling agents which replace the lost volume under the skin.
Polyalkylimide gel (PAIG, Bio-Alcamid) has become one of the most promising and widely-used facial fillers used in treating facial lipoatrophy. Multicentre studies have found PAIG to be extremely safe and effective at improving FL in some 2000 patients so far worldwide. As few or no randomised trials have been done to date, researchers at the Maple Leaf Medical clinic in Toronto, Canada conducted a small, randomised comparison of immediate vs. deferred PAIG treatment.
Week twelve: comparative results
No infections, nodules, necrosis or other serious events were seen: adverse events were limited to mild swelling, redness, bruising and pain, and lasted a median of three days.
FLSS and quality of life scores were compared at week twelve, when the immediate group had received treatment but the deferred group had not. The treated group improved by a median of 2 scale points on the FLSS, compared to no improvement in the deferred group (p
Week 48: final results
By week 48, benefits were seen in all participants, such that “no significant difference between groups was evident in any endpoint.” Overall mean FLSS scores were 0 (as physician-rated) and 1 (patient-rated) for the entire cohort. Improvements were seen in all MOS-HIV scores; the change in mental health was statistically significant (values not cited). Significant improvements were seen for all participants in rated depression (3 out of 21 points, p = 0.01) and anxiety (3 out of 21 points, p = 0.001).
The researchers acknowledge limitations in the nearly exclusively male cohort, the lack of objective skin-thickness measurements and the lack of follow-up past 48 weeks. (Cost of treatment outside the clinical trial setting is also acknowledged as a serious practical challenge.) However, treatment resulted in measurable improvements in quality of life, anxiety and depression compared to those who did not receive the treatment. The authors state that polyalkylimide gel “is a safe and effective corrective option for the correction of HIV-associated facial lipoatrophy, resulting in clinically important improvements in patient appearance, QoL, anxiety and depression.”
Loutfy M et al. Immediate versus delayed polyalkylimide gel injections to correct facial lipoatrophy in HIV-positive patients. AIDS 21: 1147-1155, 2007.