New Fill (polylactic acid) improves facial appearance and reduces anxiety wthin 12 weeks, according to the results of a randomised study presented lst week at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego. The study was carried out by Dr Graeme Moyle and colleagues at the Chelsea and Westminster Hospital in London. The findings are likely to add to pressure for the treatment to be funded by the National Health Service in the UK for patients with HIV lipoatrophy (fat loss).
New Fill is injected into the skin that covers the buccal fat pad (the main area of fat lost in lipoatrophy, lying under the cheekbone and padding the area between the nose and the jaw). It does not restore fat, but stimulates the development of collagen, thus thickening the layer beneath the surface of the skin and improving the facial appearance.
In this study, thirty individuals were randomized to receive either immediate injections of polylactic acid (New Fill) at weeks 0, 2 and 4, or deferred treatment beginning at week 12.
Assessment from photographs by six independent assessors was made at week 0, 12 and 24, and patients also made their own assessments of appearance and of depression based on a Hospital Analogue Scale.
After 12 weeks patients in the Immediate Treatment group reported improvement
Patients in the Immediate Treatment group also showed a trend towards lower Anxiety scores when compared to the Deferred Treatment group at week 12; this difference was on the borderline of statistical significance (p=0.056). Depression scores fell in both groups by week 24 (from 6 at baseline to 2 (Immediate) and 3 (Deferred) by week 24.
Reports from independent assessors are still awaited.
The only adverse events that delayed further treatment were one case of bruising and one case of cellulites. In both cases treatment was delayed no more than one week. No negative changes in average viral load or CD4 count occurred.
What does this study show?
This study is important because it is the first randomized test of New Fill. Previous promising reports did not include a control group, but in this study the immediate vs deferred study design made it possible to discern the effects of New Fill on appearance – and on psychological well-being – compared to the effects of non-treatment. The study also shows that New Fill is associated with few adverse events when administered in a clinic setting.
This study is likely to increase the pressure for New Fill treatment to be funded by the NHS in the UK, although funding arguments will have to be won at the local level, and revised British HIV Association guidelines, due in early 2003, are likely to be critical in establishing whether New Fill should be funded.
Moyle GM et al. Polylactate (NewFill) injections subjectively and objectively improve appearance and reduce anxiety and depression scores in HIV-positive persons with facial lipoatrophy: a randomised, open label, immediate vs. delayed therapy study. 42nd ICAAC, San Diego, abstract H-1934, 2002.