Studies of Polylactic Acid Continue to Show Promise in Treatment of HIV-related Facial Lipoatrophy  

The US Food and Drug Administration (FDA) in August 2004 approved Sculptra brand polylactic acid, a synthetic biodegradable polymer, for the treatment of facial lipoatrophy in HIV patients. It has been approved in Europe for several years where it is widely used as a treatment for facial wrinkles.

In a 96-week non comparative study in HIV-infected patients with severe facial lipoatrophy, 41% of patients treated with intradermal polylactic acid injections had a total cutaneous thickness of >10mm at the nasogenian fold at week 24.

Polylactic acid was injected into multiple sites of each cheek at baseline and at weeks 2, 4, and 6. Significant (p < 0.001) increases from baseline in total cutaneous thickness were reported at all evaluation time points up to 96 weeks after the start of treatment.

In a randomized, non blind study, significant (p < 0.001) increases from baseline in dermal thickness were observed at week 24 in HIV-infected patients with facial lipoatrophy who received immediate or deferred (by 12 weeks) treatment with poly-L-lactic acid, administered by injection into multiple intradermal sites every 2 weeks (three injection sessions in total).

 Improvements in depression and anxiety scores, patient visual analog scale assessments, and photographic assessments were also reported in patients treated with polylactic acid in the immediate versus deferred treatment trial.

Polylactic acid was generally well tolerated. No serious adverse events were reported.

Commentary

Sculptra appears to be safe and to work well in almost all patients with HIV-related facial atrophy. However, the price of the treatment is high. Following its approval by FDA, Sculptra manufacturer Dermick (a subsidiary of Aventis) raised the price of a single kit (two vials of solution and an injection needle) from $400 to $960. The physician fee for a single treatment is $400, bringing the cost to $1,360 for one single treatment.

The number of treatments necessary to achieve the desired effect varies, depending on the severity of the facial lipoatrophy. 4-6 treatments spaced at least 3-4 weeks apart are the norm. Thus the cost of a full course of treatment that may be effective for 2-3 years is $5,440- $8,160. Insurance coverage is not universal, despite FDA approval.

12/13/04

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