Approaches to treatment of lipodystrophy

Simon Collins, HIV i-Base

Few presentations added much to the understanding of the causes of lipodystrophy and although the most relevant presentations for clinical care included treatments that have previously been reported these studies are still important to inform the generally limited access that patients have to these options.

New-Fill for Lipoatrophy

Two poster presentations, both from Paris, reported almost identical positive results from using New-Fill, a hydrogel of polylactic acid, to treat facial lipoatrophy.

Additional safety and efficacy results from the VEGA study were presented by Camille Aubron-Olivier and colleagues from the Hopital Pitie Salpetriere in Paris.

This open label, single arm pilot study enrolled 50 patients between June 2000 and January 2001. All had severe facial lipatrophy and had lost almost all facial fat (median facial fat thickness at baseline measured by ultrasonography was 0mm, range 0.0-2.1mm). Patients received four courses of injections at nought, two, four and six weeks and results were measured at six, 24, 48, 72 and 96 weeks. Each course of injection requires approximately 20-40 deep injections into each check. Anaestetic is applied locally, often mixed with the compound, and careful massage immediately post treatment is critical to achieve best results.

Results showed cumulative benefit over the first six months of treatment that have so far been sustained over the follow-up period. The mean total cutaneous thickness increased by +5.1mm (range 2.2-8.6) at week six, +6.4 mm (3.1-9.1) at week 24, +7.2 (4.2-9.6) at week 48, +7.1 (3.5-9.6) at week72 (p<0.001) and +6.8 (3.9-10.1) at 96 weeks (p<0.001). Total cutaneous thickness remained >10mm in 43% patients at week 96

No serious adverse events were reported during the study, with minimal swelling at injection sites reported in 15 patients, which resolved within one to two days. In 22 patients (44%) palpable but non-visible subcutaneous micronodules were observed which spontaneously resolved in six patients by week 96. Visual improvements from the treatment were clear in the photographs presented and in the patient quality of life questionnaires.

A second study, from the St Louis Hospital, Paris, involving 40 patients (four women) reported benefits measured by three-dimensional photography and an analogue visual scale satisfaction index (AVSSI). Mean age was 43 (40-58), mean CD4 525 cells/mm3, viral load <50 copies in 44% patients (two patients were not on ARV treatment) at baseline.

Patients received a mean 4.4 injections (±0.7) with a mean injected volume of 2.7ml PLA, mixed with lidocaine, per cheek.

Mean AVSSI increased significantly from 3.3 ±2 after two injections to 7.2±1.5 two months after the end of treatment which was sustained six months after the end of treatment. Mean increase in dermal thickness six months after treatment was 3.4±1.8mm and 2.2±1.2 in the right and left checks respectively.

No serious side effects were reported. Grade 1-2 pain was noted in 76% patients.

References:

1. Valantin M, Aubron-Olivier C, Katlama K et al. Polylactic Acid implants (New-Fill) in the correction of facial lipoatrophy in HIV-infected patients (VEGA Study): Results at 72 weeks. Abstract 719.

2. Lafaurie M, Dolivo M Molina J. Treatment of facial lipoatrophy with injections of Polylactic Acid in HIV-infected patients. Abstract 720.

comment

This treatment has received a lot of attention over the last two years and the 24-week results from this study were presented at the i-Base meeting on facial lipoatrophy just over a year ago. Since then, several clinics have expanded provision of this important corrective procedure within the NHS. Many other patients have paid for treatment privately.

Clinics currently providing New-Fill emphasise that this service is currently for their regular patients. However, establishing specialist clinics will also mean that later they will be available for referrals from other hospitals. It is estimated that between 5% and 10% of patients currently using antiretroviral treatment may have lipoatrophy that could benefit from New-Fill.

Brighton has treated approximately 50 patients over this year. The main hospitals in the North Thames region (Chelsea and Westminster, Ealing, St Mary’s and West Middlesex) have already carried out a needs assessment programme and trained specialists to provide treatment. Although patients have yet to benefit from this, the programme is expected to open shortly. The Royal Free Hospital obtained funding for a limited course of treatments, and Manchester General continued to treat patients over the year.

Although there is still no clear etiology for facial lipoatrophy, this treatment appears to provide a safe and minimally invasive repair procedure that can minimise the social and psychological distress that these symptoms cause.

In the VEGA study in the poster the decrease in patients with >10 mm cutaneous thickness over time was paralleled by a decrease in QoL rating on visual analogue scales suggesting the need for repetition of the injections at least in some patients. In addition not all patients respond well to the injections (range of dermal thickness) stressing the need for safe alternative procedures.

	HIV Treatment Bulletin Vol 4 No 3 April 2003