Further reports of benefits of polylactic acid for facial lipoatrophy
Simon Collins, HIV i-Base
Use of polylactic acid (New Fill) for facial lipoatrophy was first reported at last years workshop on lipodystrophy (see: www.i-base.info/htb/3945). Coverage from that meeting generated immediate interest from both patients and clinicians, especially given the lack of alternative treatments available.
A larger study quickly enrolled in Paris under Christine Katlama, and later two UK studies enrolled at the Royal Free and Chelsea and Westminster Hospitals in London. Preliminary results from the Parisian study were presented at ECCATH by Dr Camille Aubron-Olivier and are reported here.
NewFill is a hydrogel of polylactic acid (PLA) and importantly for a local rather than systemic treatment, is biodegradable rather than a permanent procedure. The use of permanent implants are problematic given the unknown development of future treatments. PLA was approved in 1999 by the European Authorities for Medical Devices as a treatment for ‘aesthetical correction’ of scar tissue and wrinkles.
The primary endpoint of this open label pilot study, was change in subcutaneous dermal thickness between baseline and month six. Secondary endpoints include dermal thickness at 12, 18 and 24 months, percentage of patients with thickness >10mm at these time points, tolerance and safety and visual analogue scale of well being. Subjects had to have been on ARV therapy for >3 years, with a <2mm thickness of adipose tissue measured by ultrasonography, and a viral load <5000 copies/ml. Exclusion criteria included current dermatological disease, previous implants (within 6 months), current interferon therapy and pregnancy.
0.5 g PLA was injected into each cheek every 2 weeks for 2 months and a fifth injection was provided if dermal thickness was still <8mm. All injections were performed by the same trained dermatologist and lidocaine was administered as local anaesthetic.
Of the 50 patients (49 men, 1 woman) available for this analysis, 4, 29 and 17 had received 3, 4 and 5 injections respectively. Median time on treatment was 8.6 years (range, 4.0-14.1), including RTI monotherapy. Median CD4 was around 400 (range 127-807). Importantly median adipose tissue thickness was 0mm (range 0-2.1mm). Although facial atrophy was the subject of the study, fat loss from arms and legs was apparent in 43 and 22 patients respectively. 10 patients had breast enlargement and 15 had increased intraabdominal fat.
Evolution of mean total subcutaneous tissue changed from 2.9mm (range 2.1-5.5) at baseline to 8.1mm (4.2-11.9) at month 2 and 9.5mm (6-12.6) at month 6. Both changes were statistically significant (p<0.001). 10% patients at month 2 and 40% at month 6 had total dermal thickness >10mm.
No serious adverse events were reported in the study. Minimal oedema localised to injection site was reported by most patients, which resolved within 1-2 days. 10% patients experienced non visible 3-5mm subcutaneous nodes between month 3-6, which were reported to reduce after this time. Fifteen patients with pre-existing telangiectasis experienced minimal eccymosis which resolved rapidly.
It is easy to underestimate the impact on QoL for patients with moderate-severe lipodystrophy. Severe forms are associated with a similar AIDS associations as was previously experienced by people with facial KS lesions. Numerous studies have reported negative psychological impact on emotional and social health. Even mild signs are associated with increased anxiety, distrust of current treatment, and for people still treatment naïve, a reluctance to initiate HAART. Although this is a local treatment, the benefits reported should increase pressure on these procedures to be available within the NHS. It is also important that this is an approved product and that the results are non permanent.
Results from a patient-completed questionnaire presented at the previous lipodystrophy workshop showed a very high interest and awareness of these procedures in France, but that these were still not available to 75% people who needed them.
As noted polylactic acid breaks down over time in the body. One of the breakdown products is lactic acid and concerns were raised about the impact of this on blood lactate levels as well as the possible implication of this in the setting of hyperlactataemia. A delegate responded to these concerns by stating that lactate levels had been monitored during their use of the procedure and had been noted to rise transiently for a few days after the injections only. The delegate also reported that the procedure had been used in haemophiliac patients with no additional adverse effects than those noted in the study presented.
Aubron-Olivier, C – An open label pilot study of polylactic acid filler (NewFill) in HIV infected patients with severe lipoatrophy. 8th ECCATH, Athens 2001. Abstract O20.
Trenado, E – Results of a patient-filled questionnaire about facial lipoatrophy and its repair procedures in France. 3rd Intl Workshop on Adverse Drug Reactions and Lipodystrophy, 23-26 Oct01, Athens. Abstract 122.