Injections of PLA improved patients' self-perception of facial lipoatrophy, with a good safety profile. The benefit of the procedure, however, decreased with time.

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...

BackgroundMany HIV patients receiving antiretroviral treatment develop lipodystrophy. NEW-FILL® is a polylactic acid injected to treat facial lipoatrophy. The objectives of this study were to describe (1) change in quality of life (QoL) of HIV patients treated with NEW-FILL® in the management of facial lipoatrophy; (2) efficacy of NEW-FILL® using facial photographs and (3) a patient-reported “Overall Treatment Effect” (OTE) scale; and (4) safety of NEW-FILL®.MethodsDoctors from 13 treatment centres recruited 230 HIV patients to receive up to 5 sessions of NEW-FILL® injections. Patients self-reported QoL with the ABCD questionnaire before the first set of injections, at 2 months and at 12 to 18 months after the last session of injections. Efficacy was evaluated at each interval through photographs and OTE scale. Safety was evaluated via Case Report Form (CRF) data.Results64.4% of patients reported QoL improvements of >10% at 2 months, and 58.8% at 12–18 months. Lipoatrophy grades improved at each visit (“no lipoatrophy” or “limited lipoatrophy”: 20.3% at inclusion, 77.4% at 2 months, 58.4% at 12–18 months). Average OTE scores of 5.3 and 5.0 at 2 and 12–18 months indicated “moderate improvement”. Minimum Important Difference (MID) in QoL score was 7.1 points at 2 months; 7.4 points at 12–18 months. For 911 injection sessions performed, 3.4% resulted in “immediate” adverse events, 7% in “non-immediate” events, and 1.7% in “other” events.ConclusionsImprovements to quality of life and diminished lipoatrophy visibility were observed in the months immediately following NEW-FILL® treatment and were maintained 12–18 months post-treatment. Most adverse events were mild and transient. ABCD MID thresholds provide clinicians with means to assess the impact of lipoatrophy therapies on QoL.

BackgroundFacial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV) drugs. Poly-L-lactic acid (PLLA) acid has been used to correct facial lipoatrophy in people with HIV since 2004 both in Europe and the United States. The objective of this study was to establish, in real life conditions and in a large sample, the safety of PLLA (New Fill®, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients.MethodsA longitudinal study was conducted between 2005 and 2008 in France. Data from 4,112 treatment courses (n = 4,112 patients) and 15,665 injections sessions (1 to 5 injection sessions per treatment course) were gathered by 200 physicians trained in the use of PLLA.ResultsThe average age of patients (88.3% males) treated for lipoatrophy was 47.1 ± 8.1 years (Mean ± SD); 91.2% of patients had been receiving ARV treatment for 10.9 (±4.2) years; CD4 T-cell count was 535 ± 266 cells/mm3. The duration of facial lipoatrophy was 5 ± 2.8 years and the severity was such that 47.3% of patients required five injection sessions of PLLA and 81.9% of the sessions required two vials of the preparation. The final visit, scheduled two months after the last injection session, was attended by 66.0% of patients (n = 2,713). 48 treatment courses (2.8%) were discontinued due to adverse events (AEs). The overall incidence of AEs per course was 18.8%. Immediate AEs, bleeding (3.4%), bruising (2.3%), pain (2.0%), redness at injection site (1.6%), and swelling of the face (0.7%), occurred in 15.4% of courses and 7.0% of sessions (usually during the first session). Non-immediate AEs, mainly nodules (5.7%), inflammation (0.7%), granuloma (0.3%), discolouration (0.2%), and skin hypertrophy (0.1%), occurred in 6.7% of courses. Non-immediate AEs occurred within a time ranging from 21 days (inflammation) to 101 days (granuloma) and all but three of the 13 cases of granuloma resolved. Product efficacy was rated satisfactory by 95% of the patients and physicians.ConclusionsThis study demonstrated, in real-life conditions and on a large sample, that PLLA injections were feasible, efficient, and safe when performed by trained physicians.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2334-14-474) contains supplementary material, which is available to authorized users.