Polylactic acid vs. polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 132 SMILE]

Abstract

ObjectivesThe aim of the study was to demonstrate the noninferiority of polyacrylamide hydrogel (PH) vs. polylactic acid (PLA) for the treatment of facial lipoatrophy in HIV-infected adults. MethodsA randomized, blinded, multicentre, noninferiority 96-week study was carried out. Patients with facial lipoatrophy were randomly assigned to receive intradermal injections with PH or PLA, and were blinded to the filler. The primary efficacy endpoint was patient satisfaction at week 48 assessed using a visual analogue scale score (VAS). Secondary efficacy end-points included cheek thickness and skin-fold, lipoatrophy grading and quality of life. Safety was assessed by the reporting of adverse events. ResultsA total of 148 patients were included in the study; 93% were men, the median age was 47 years, the median CD4 count was 528 cells/mL, and the median duration of antiretroviral therapy was 12 years. Mean VAS increased from 2.8 at baseline to 7.1 and 7.5 in the PLA and PH arms, respectively, at week 48 (P = 0.0002 for noninferiority) and was sustained at week 96 (6.7 and 7.9 in the PLA and PH arms, respectively; P = 0.003 for noninferiority). Cheek thickness and skin-fold increases and lipoatrophy improvement were similar in the two arms. Quality of life remained unchanged or improved depending on the questionnaire used. In injected patients, subcutaneous nodules emerged in 28 (41%) and 26 (37%) patients in the PLA and PH arms, respectively (P = 0.73). Four patients in the PH arm developed severe inflammatory nodules, a median of 17 months after the last injection. ConclusionsPH and PLA have similar efficacies in the treatment of facial lipoatrophy, but PH may be associated with more delayed inflammatory nodules. IntroductionFacial lipoatrophy is still a prevalent and stigmatizing complication of antiretroviral therapy that can severely affect quality of life and self-esteem, and may result in reduced antiretroviral compliance [1,2]. The pathogenesis of lipoatrophy is multifactorial but the toxicity of thymidine analogue antiretrovirals is likely to play a major role [3]. Current therapeutic options are limited. Reversibility of lipoatrophy after switching to thymidine analogue-sparing regimens is at best slow and limited [4,5]. Use of thiazolidinediones, pravastatin or uridine has produced rather disappointing results, especially regarding the correction of facial lipoatrophy [6][7][8]. For these reasons, plastic surgery and dermal fillers are treatments of choice for facial lipoatrophy. Autologous fat transplantation (AFT) is a surgical procedure that needs harvestable fat in patients, and which can be associated with resorption or hypertrophy of transferred fat [9,10]. Injections of facial fillers have therefore become the standard of care for patients with lipoatrophy. Three biodegradable filling compounds have received Food and Drug Administration (FDA) approval for correction of facial lipoatrophy in HIV infection: calcium hydroxyapatite gel, hyaluronic acid and poly-L-lactic acid (PLA) [10]. However, most stud...

Ten-Year Safety with Polyacrylamide Gel Used to Correct Facial Lipoatrophy in HIV-Infected Patients

“…Safety was mainly assessed 2 years after the infiltrations, [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] although some publications have reported a longer followup-up to 4-5 years-in the case of polyacrylamide gel. [20][21][22][23] Data from this report are particularly relevant, considering that polyacrylamide gel is a permanent filler for which no data are available beyond 5 years.…”

“…The rate ranges from 5% 14,18 to 41% of patients. 17 A review including 19 studies with 724 patients (549 in the hyaluronic acid or polylactic acid cohort) reported subcutaneous nodules in 22% of patients. 15 Most studies included patients who received polylactic acid.…”

“…Infiltrations with synthetic substances or autologous fat were offered to many patients affected with facial lipoatrophy. [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] Since some of the fillers were permanent substances, their long-term safety remains a concern, although preliminary results show a low prevalence of short-term and medium-term complications. [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] …”

Introduction to Fillers

“…PAAG has been evaluated in clinical trials for facial contouring, deep rhytides and folds, and the correction of facial lipoatrophy [141][142][143][144][145][146][147][148] with efficacy similar to nonanimal stabilized hyaluronic acid and a duration of at least 1 year when used for the treatment of nasolabial folds. European Conformitymarked in Europe in 2001 for facial augmentation and minor body contouring, PAAG is available in more than 40 countries worldwide and awaiting FDA approval.…”

23 Injectable Fillers of the Face

“…Two cases of anaphylaxis to a soft tissue filler are reported in the literatureone to PMMA and another to PLLA. 53,118 Adverse events that potentially require intervention are discussed below. 119…”