Long-term Safety and Efficacy of Poly-L-lactic Acid in the treatment of HIV-related Facial Lipoatrophy

There is currently no known effective treatment for HIV-related facial lipoatrophy, a condition that may result in a significant decrease in the quality of life of affected patients. However, there is now an FDA-approved cosmetic intervention-injections with Poly-L-lactic acid (PLLA) [Sculptra]-that both doctors and patients report as being safe and effective and yielding beneficial cosmetic results in almost all cases.

In the current study, conducted at Chelsea and Westminster Hospital in London, UK, researchers evaluated the long-term safety and efficacy of injectible PLLA for the correction of facial lipoatrophy.

This was a randomized, open-label, comparative, single-centre study of injected PLLA in patients with HIV-related facial lipoatrophy.

Thirty subjects were randomized to immediate or delayed PLLA treatments, administered as three sets of bilateral injections, 2 weeks apart, into the deep dermis above the buccal fat pad. Week 24 results have been published previously (Moyle et al, HIV Medicine 2004, Vol. 5, pp. 82-87).

Long-term efficacy was assessed at a recall visit using visual analogue scales (VASs) to record patient satisfaction, and by the Hospital Anxiety and Depression Scale (HADS). Patients also reported any adverse events (AEs) during the treatment period and at the recall visit. Twenty-seven patients returned for the recall visit, a minimum of 18 months post final study treatment.

Results

Improvements in VAS scores for facial appearance were sustained from baseline to the recall visit in both randomization groups (P<0.05 and P<0.001).

Trends in improvement in HADS scores were also noted, with patients in the delayed group experiencing significant improvements in depressive symptoms (P<0.05).

One case of injection-site induration and nine cases of injection-site nodules were noted at the recall visit, none of which was described as serious or severe.
In conclusion, the authors write, "Physical and psychological benefits of PLLA are sustained over at least 18 months. Delayed adverse events include mild nodularity at the treatment site."

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Study of Polylactic Acid Injections (PLA) for Cosmetic Management of Facial Lipoatrophy - 3/15/04

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Facial Implants for HIV and HAART-related Lipoatrophy: An Interview with Dr. Gottfried Lemperle 11/19/03

Promising Results from a Pilot Study of Polylactic Acid Implants (New-Fill)® to Correct Facial Lipoatrophy in HIV Patients 11/12/03

03/17/06

Reference
G L Moyle and others. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-related facial lipoatrophy. HIV Medicine 7 (3), 181-185. April 2006.