Long-Term Psychometric Outcomes of Facial Lipoatrophy Therapy: Forty-Eight–Week Observational, Nonrandomized Study

Orlando, Gabriella; Guaraldi, Giovanni; Fazio, Domenico De; Rottino, Antonio; Grisotti, A.; Blini, M.; G, De Santis; Pedone, Antonio; Spaggiari, Andrea; Baccarani, Alessio; Vandelli, Maria Angela; Paola, Maria De; Comelli, D.; Nardini, Giulia; Beghetto, Barbara; Squillace, Nicola; Esposito, Roberto

doi:10.1089/apc.2007.0029

Cited by 23 publications

(49 citation statements)

References 18 publications

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“…In the current study, clinicians actively sought and palpated for nodules/papules, while others may have relied solely on patient report. Nodule onset times were consistent with those reported previously [13,35]; however, data on nodule duration are incomplete as many remained ongoing at study closure [9,13,17,33].…”

Section: Discussionsupporting

confidence: 86%

“…These changes, while lower than the week 48 changes reported in some studies [9,11,17], are comparable to those reported in others [13,14]. However, cross-study comparisons of PLA efficacy for HIV facial lipoatrophy are problematic because of the heterogeneity of these studies.…”

Section: Discussionsupporting

confidence: 56%

“…Validated measures of facial soft tissue thickness or volume for assessing and/or comparing treatment efficacy are also lacking. Measurement methods employed have included ultrasonography [9,14,17], callipers [11], and 3D photography with 3D computerized reconstruction of the face [13], none of which has been validated. Collectively, these factors demonstrate the lack of scientifically valid data that relate Table 2 Overall procedure/product-related adverse events to week 48 to this treatment approach, and assist in explaining the broad inter-study variability in PLA treatment outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…Although open-label studies have demonstrated PLA safety in HIV-infected adults [9][10][11][12][13][14][15][16][17][18], PLA efficacy has been objectively assessed in only one randomized clinical trial [19]. This open-label, multicentre study compared immediate vs. deferred PLA injections in adults with moderate to severe facial lipoatrophy.…”

Section: Introductionmentioning

confidence: 99%

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Poly‐l‐lactic acid for HIV‐1 facial lipoatrophy: 48‐week follow‐up

Carey¹,

Baker²,

Petoumenos³

et al. 2009

HIV Medicine

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ObjectivesPoly-L-lactic acid (PLA) injections modestly increase objectively assessed facial thickness but not facial soft tissue volume (FSTV) over 24 weeks. The durability of this response has not been well defined objectively. MethodsHIV-infected lipoatrophic adults were randomized to four open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n 5 50) or from week 24 (deferred group, n 5 50). Endpoints included FSTV assessed by computed tomography, facial lipoatrophy severity, quality of life (QoL) and safety. Analyses were by intention to treat. ResultsBetween weeks 24 and 48, soft tissue thickness increased modestly in injection planes, at the maxillary [mean 0.9 mm; 95% confidence interval (CI) 0.3-1.5 mm; P 5 0.007] and base of nasal septum levels (mean 0.4 mm; 95% CI 0.1-0.8; P 5 0.021), but not in untreated areas (P 5 0.79 and P 5 0.24). PLA durability assessed at week 48 in immediate group participants showed a mean change in FSTV of 14 cm 3 (95% CI À1 to 29 cm 3 ; P 5 0.060) and increased tissue depth at the maxillary (Po0.0001), base of nasal septum (Po0.0001) and mandibular (P 5 0.0035) levels. At week 48, clinicians and patients subjectively assessed facial lipoatrophy severity as reduced in immediate participants (83 and 91%, respectively), and the Mental Health scale score of the Short Form-36 Health Survey improved significantly in immediate participants relative to deferred participants (P 5 0.027). Subcutaneous injection-site nodule incidence at 48 weeks was 10%. ConclusionsPLA treatment benefits were durable, with objectively assessed modest increases in facial volume and tissue thickness sustained over 48 weeks in injection planes but not in other facial areas. Improvements in some QoL domains were maintained. IntroductionLipoatrophy of subcutaneous adipose tissue in the limbs, face and buttocks, and accumulation of adipose tissue in the intra-abdominal space, dorsocervical region and the breasts are major features of HIV lipodystrophy [1,2].Facial lipoatrophy, the most distressing manifestation, can be stigmatizing, severely affecting quality of life (QoL) and self-esteem, and may result in reduced antiretroviral (ARV) adherence [3]. Although use of the newer nonthymidine nucleoside reverse transcriptase inhibitors is associated with less lipoatrophy [4], in the absence of proven therapies, management of established fat loss can be challenging as reversal is slow [5][6][7].An array of injectable filling agents has been marketed for soft tissue augmentation and many of these are used for aesthetic management of HIV facial lipoatrophy [8]. Methods ParticipantsDetails of participants' eligibility, randomization and baseline characteristics have been reported previously in the 24-week primary efficacy comparison [19]. All participants provided written, informed consent following approval by the local human research ethics committee at each site. InterventionsAt baseline, 100 eligible patients were randomized to receive four open-label PLA treatments [one vial (150 m...

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Poly‐l‐lactic acid for HIV‐1 facial lipoatrophy: 48‐week follow‐up

Carey¹,

Baker²,

Petoumenos³

et al. 2009

HIV Medicine

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“…There are new and encouraging data on surgical treatment of facial lipoatrophy. 19 However, such treatment is usually not available in low and middle income countries.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Ultrasound for Use in Detecting Lipoatrophy in HIV-Infected Patients Taking Combination Antiretroviral Therapy

Višković

Richman²,

Klasnic³

et al. 2009

AIDS Patient Care and STDs

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The aim of this study was evaluation of ultrasound (US) as a tool for the assessment of lipoatrophy in a population of HIV-infected patients. We enrolled a convenience sample of 151 HIV-infected Caucasian participants (males, 79%) who were treated for at least 1 year with combination antiretroviral therapy (CART) in Zagreb, Croatia. US measurements of subcutaneous fat thickness were done over the malar, brachial, and crural region. We determined sensitivity and specificity of US as a diagnostic tool for lipoatrophy using receiver-operating curves and concordant patient and clinician assessment as our reference for the presence of lipoatrophy. HIV was acquired through heterosexual contact in 50% of participants and by sex between men in 42%. The mean current CD4 cell count was 503.1 cells=mm 3 (standard deviation [SD] ¼ 250.8). Seventy-seven (51%) participants were treated with stavudine and 91 (64%) with a protease inhibitor for at least 6 months. Nineteen (13%) participants had lipoatrophy in at least one anatomic site. Sensitivity of US ranged from 67%-71%, specificity from 65%-71%, positive and negative predictive values ranged from 11%-20% and 96-97%, respectively. USdiagnosed lipoatrophy was more frequently found in patients with a history of stavudine treatment and in females. Patients with lipoatrophy had a longer duration of CART than those without lipoatrophy. US is a useful tool in ruling out the presence of clinical lipoatrophy in patients on CART. Using this objective measure of subcutaneous fat may be useful in helping clinicians make decisions about changing therapy.

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Efficacy and Safety of Autologous Fat Transfer in Facial Reconstructive Surgery

Krastev

Beugels

Hommes

et al. 2018

JAMA Facial Plast Surg

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IMPORTANCEThe use of autologous fat transfer (AFT) or lipofilling for correcting contour deformities is seen as one of the major breakthroughs in reconstructive plastic surgery. Its applications in facial reconstructive surgery have been of particular interest owing to the prospect of achieving autologous reconstruction by a minimally invasive approach. However, its unpredictability and variable degree of resorption have limited its utility and much skepticism still exists regarding its efficacy. Furthermore, more than 2 decades of clinical research have produced a highly fragmented body of evidence that has not been able to provide definite answers. OBJECTIVE To investigate the safety and efficacy of AFT in facial reconstruction through a systematic review and meta-analysis.

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Long-Term Psychometric Outcomes of Facial Lipoatrophy Therapy: Forty-Eight–Week Observational, Nonrandomized Study

Cited by 23 publications

References 18 publications

Poly‐l‐lactic acid for HIV‐1 facial lipoatrophy: 48‐week follow‐up

Poly‐l‐lactic acid for HIV‐1 facial lipoatrophy: 48‐week follow‐up

Assessment of Ultrasound for Use in Detecting Lipoatrophy in HIV-Infected Patients Taking Combination Antiretroviral Therapy

Efficacy and Safety of Autologous Fat Transfer in Facial Reconstructive Surgery

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