Today at the 8th European Conference on Clinical Aspects and Treatment of HIV infection in Athens preliminary results were presented from the Vega study which is evaluating the safety and efficacy of polylactic acid, also known by the trade name New Fill for the treatment of severe facial lipoatrophy.
Facial lipoatrophy occurs in between 30%-40% of HIV-positive people using HAART. New Fill has been traditionally used in reconstructive surgery and has been approved by G-MED for the aesthetic correction of scars and wrinkles.
Dr Camille Aubron-Olivier of the Sevice des Maladies Infectieuses et Tropicales, at Pitie Salpetriere Hospital in Paris today presented data on the 50 patients enrolled in the study between June 2000 and February 2001.
New Fill injections of one vial of New Fill (0.15g) in each cheek took place at day 0, 15, 30 and 45 with the option of a further fifth injection at day 60, if dermal thickness was still less than 8mm. So far 4 patients have received 3 injections, 29 patients have received 4 injections and 17 patients have received 5 injections.
The median age of the patients was 46 years and average CD4 cell count and viral load measurements were 396 cells and 2.3 log respectively. This group of patients are highly treatment experienced (8.6 years of treatment on average), with 96% having used NRTIs, 60% protease inhibitors and 40% NNRTIs. In total 49 men and one woman were enrolled.
To be included in the trial, patients had to have used HAART for a minimum of 3 years, have a viral load of less than 5,000 copies and subcutaneous adipose tissue thickness less than 2mm as measured by ultrasonography. They were excluded if they had prior facial implants or were pregnant.
Prior to the first injection, the median thickness of facial adipose tissue was 0mm [range 0-2.1mm]. At month two, the median increase in dermal thickness in all patients was 8.1mm, by month six this had increased to 9.5mm.
The reduction in facial atrophy could be noticed in most of the patients as soon as the second injection and improved further with subsequent injections.
Following the injections, patients were assessed by clinical examination, further ultrasonography and by photograph. Assessment occurs at month 3, 6, 12, 18 and 24. Photographs of three patients were shown at the conference today, and the results appear very convincing.
No patients discontinued the treatment. No serious adverse events were reported. Some injection site reactions occurred. The authors commented that the treatment improved quality of life since all patients reported an improvement in their sense of well-being, though at month six some patients had reported feeling worse about their appearance.
The research team will report on the long-term durability and tolerance of the treatment at month 24 in future meetings.
Aubron-Olivier C et al. Benefit of Polylactic Acid Implant (New Fill) in Severe Facial Lipoatrophy in HIV infected Patients: Preliminary Results of the Vega Study. 8th Conference on Clinical Aspects and Treatment of HIV Infection, Athens. Abstract O20, 2001.