HIV-associated Facial Lipoatrophy Research Articles

Treatment of Human Immunodeficiency Virus-Associated Facial Lipoatrophy With Hyaluronic Acid Filler Mixed With Micronized Cross-Linked Acellular Dermal Matrix.

BackgroundHuman immunodeficiency virus (HIV)-associated facial lipoatrophy (FLA) is a stigmatizing side effect associated with the use of highly active antiretroviral therapy. We sought to evaluate the safety and efficacy of the hyaluronic acid filler mixed with micronized cross-linked acellular dermal matrix (HA/MADM) in HIV-associated FLA.MethodsWe conducted an open-label safety and efficacy study in patients with HIV-associated FLA. Fourteen patients received single injection of the HA/MADM, and 13 patients completed the 24-week follow-up evaluation. Treatment efficacy, safety, and patient and physician satisfaction were evaluated. Repeated measure analysis of variance with post-hoc analysis with the Wilcoxon signed rank test was performed to compare and incorporate parameters at each time point.ResultsAll 13 patients maintained a significant improvement of the Carruthers Lipoatrophy Severity Scale grade throughout the study period, along with improvement of the depressed volume due to lipoatrophy measured using a three-dimensional camera system. More than 80% of patients and physicians were satisfied with the treatment, and no treatment-related adverse events were reported, except for one case of transient subcutaneous nodule formation.ConclusionOur study findings suggest that injectable HA/MADM is a potentially effective and safe treatment option for treating HIV-positive patients with FLA.

Ten-Year and Beyond Follow-up After Treatment With Highly Purified Liquid-Injectable Silicone for HIV-Associated Facial Lipoatrophy: A Report of 164 Patients.

Highly purified liquid-injectable silicone (LIS) has been established as a permanent agent for off-label correction of HIV-associated facial lipoatrophy (HIV-FLA). However, controversy exists about long-term safety. To establish the safety and efficacy at 10 years or greater of LIS for HIV-FLA. Patients from 3 practices with 10-year or greater in-person office follow-up were analyzed to determine the number of LIS treatments and total volume required to achieve optimal correction. The nature of any treated adverse events was noted. One hundred sixty-four patients had 10-year or greater in-office follow-up. All subjects maintained long-term correction with an average of 9 treatments, average of 1.56 mL per treatment, and an average total of 14.1 mL. Two patients had severe adverse events manifesting as temporary facial edema. Four patients experienced mild-to-moderate excess fibroplasia presenting as perceived overcorrection, and 6 patients had nondisfiguring subcutaneous firmness. All adverse events were successfully treatable, mostly with intralesional 5-fluorouracil and triamcinolone. Liquid-injectable silicone is an effective long-term treatment option for HIV-FLA. When injected in small quantities with the microdroplet serial puncture technique at monthly or greater intervals, optimal correction appears durable for more than 10 years. Adverse events consisted mostly of excess fibroplasia and were treatable.

Hyaluronic Acid Filler in HIV-Associated Facial Lipoatrophy: Evaluation of Tissue Distribution and Morphology with MRI

Objective: This prospective observational study evaluated magnetic resonance imaging (MRI) findings of hyaluronic acid (HA) injections used for the correction of HIV-associated facial lipoatrophy. Methods: Ten consecutive males underwent subdermal HA injection (mean 1.3 ± 0.6 ml per side) and MRI examinations prior to and then 1, 6 and 12 months after injection. Two radiologists blinded to the clinical data assessed morphologic and quantitative changes. Results: MRI revealed HA deposition in the subdermal and deep fat compartments. A significant HA volume increase was observed 1 month after injection (mean increase 331%, p < 0.0001) as compared to the injected amount. No volume reduction occurred at 12 months (p = 0.9961). The measured bound water content did not change (p > 0.9991), whereas skin thickness and tissue vascularization increased during the first 6 months (p = 0.01). Conclusion: Our data show that the cosmetic results of HA injections are caused by water binding in the deep facial fat and by a transient increase in vascularization and skin thickness.

Treatment of HIV-associated facial lipoatrophy: impact on infection progression assessed by viral load and CD4 count

BACKGROUND HIV/AIDS-Associated Lipodystrophy Syndrome includes changes in body fat distribution, with or without metabolic changes. The loss of fat from the face, called facial lipoatrophy, is one of the most stigmatizing signs of the syndrome. OBJECTIVESTo evaluate the effect of FL treatment using polymethylmethacrylate (PMMA) implants on disease progression, assessed by viral load and CD4 cell count. METHODS This was a prospective study of 44 patients treated from July 2009 to December 2010. Male and female patients, aged over 18 years, with clinically detectable FL and who had never been treated were included in the study. PMMA implantation was done to fill atrophic areas. Laboratory tests were conducted to measure viral load and CD4 count before and after treatment. RESULTS Of the 44 patients, 72.72% were male and 27.27% female, mean age of 44.38 years. Before treatment, 82% of patients had undetectable viral load, which increased to 88.6% after treatment, but without statistical significance (p = 0.67). CD4 count before treatment ranged from 209 to 1293, averaging 493.97. After treatment, the average increased to 548.61. The increase in CD4 count after treatment was statistically significant with p = 0.02. CONCLUSION The treatment of FL with PMMA implants showed a statistically significant increase in CD4 count after treatment, revealing the impact of FL treatment on disease progression. Viral load before and after treatment did not vary significantly.

HIV-associated facial lipoatrophy treated with injectable silicone oil: A pilot study

Facial lipoatrophy (FLA) is associated with HIV infection and is part of the lipodystrophy syndrome. Temporary filler treatments do not meet the need of the patient, as there is a lack of permanence, and excessive cost. We sought to evaluate the safety and efficacy of a highly purified medical-grade 1000-cst liquid injectable silicone in the treatment of HIV-associated FLA using the serial microdroplet injection technique. Twenty patients with HIV-associated lipoatrophy were treated with liquid injectable silicone with a maximum of 6 treatment sessions (2.0 mL each session maximum). Patients were evaluated at 9-, 12-, and 18-month follow-up sessions. Safety, efficacy, injection volumes, and patient satisfaction were evaluated. No persistent adverse effects were reported throughout the study. Most of the patients achieved complete correction of their HIV-associated FLA after 6 treatments and maintained this correction to the 18-month follow-up. This is a noncomparative, nonblinded study. Study patient population size is small. Given our small sample size of 20 patients, our results suggest that, if administered correctly, liquid injectable silicone is potentially a safe, effective, and natural-feeling treatment option for HIV-associated FLA. Larger studies may be needed to confirm safety, efficacy, and permanence.

Techniques for the Optimization of Facial and Nonfacial Volumization with Injectable Poly-l-lactic Acid

With the recognition of the key role of volume loss in the facial aging process, injectable dermal fillers and volumizers have become increasingly important treatment options for recontouring and rejuvenating the aging face. While replacement fillers effectively correct individual lines and wrinkles, volumizing agents that replace collagen provide a longer-lasting, volume-based alternative. Poly-L-lactic acid (PLLA) has been shown to increase dermal thickness and volume for up to 2 years and beyond. Although early clinical use of this agent in patients with HIV-associated facial lipoatrophy was associated with a significant rate of nodule or papule formation, subsequent experience has helped define the proper reconstitution volumes and injection techniques for optimizing results and minimizing nodule/papule formation. While injectable PLLA has been used successfully for rejuvenation of most facial areas, increasing experience suggests that it is a versatile agent capable of providing aesthetic enhancement in multiple areas of the body, including the dorsum of the hands, the décolleté, the neck, the buttocks, the medial ankles, and acne scars. Although the current published experience in these areas is limited, further studies and clinical use of injectable PLLA will clarify the potential of this agent as a minimally invasive alternative and/or adjunct to surgery for restoring volume loss in multiple anatomic areas. This journal requires that authors assign a level of evidence to each article.

Commentary: Treatment of HIV Associated Facial Lipoatrophy: 2012 Update

Commentary: Treatment of HIV Associated Facial Lipoatrophy: 2012 Update

Injectable Poly-l-Lactic Acid for Human Immunodeficiency Virus–Associated Facial Lipoatrophy: Cumulative Year 2 Interim Analysis of an Open-Label Study (FACES)

Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. To report cumulative year 2 interim study results examining the safety and efficacy of injectable PLLA in subjects with HIV categorized according to Fitzpatrick skin type and sex. This is an ongoing open-label, multicenter, 5-year study of 290 treated subjects. After correction with injectable PLLA, subjects are being followed annually. Primary end points include incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points include mean change from baseline of James scale severity grade and treatment satisfaction. At 2 years, TEAE incidences were: potentially related to study product (n = 53,18.3%) or injection procedure (n = 71, 24.5%), injection-site nodules (n = 24, 8.3%) and papules (n = 25, 8.6%). No hypertrophic scars, keloids, or product-related serious TEAEs were reported. Mean improvement in James scale grade for all groups was 1.4 (p < .001), and 89.4% of subjects and 95.5% of physicians rated treatment satisfaction as very good or excellent. At 2 years, injectable PLLA is a safe and effective long-term treatment for HIV-associated facial lipoatrophy regardless of Fitzpatrick skin type; confirmation of these results will be needed at the completion of this 5-year study.

Patient satisfaction following Bio-Alcamid injection for facial contour defects

Bio-Alcamid, a polyalkylimide gel, can be injected into subcutaneous tissue as an endoprosthesis for correcting contour deformities and soft tissue defects. We have reviewed its facial uses and longer-term outcomes over a 7-year period, including a patient satisfaction survey. 69 patients were included in the study, 89.9% undergoing treatment secondary to HIV-associated facial lipoatrophy. 55.0% of patients responded to questionnaires: 52.5% experienced severe pain associated with injections, and 50.0% experienced at least one complication (migration, hardening, irregularity). 94.4% stated an improvement in their cheek volume, 77.8% would undergo the procedure again, and 86.1% would recommend the treatment to a friend. Despite the relatively high patient satisfaction, we no longer recommend this treatment to our patients for cosmetic indications, due to significant long-term complication rates.

Four-Year Follow-Up of Polyalkylimide Gel Use for the Treatment of HIV-Associated Lipoatrophy

Purpose: To evaluate polyalkylamide gel (PAIG) use in treating HIV-associated facial lipoatrophy (FLA) 4 years after its injection in an open-label, randomized controlled trial (RCT). Methods: Five patients were treated with PAIG in a pilot study, and 31 patients were subsequently enrolled in the RCT of immediate or delayed (12 weeks later) PAIG injections. Endpoints included proportion of participants with complications; changes in FLA severity score (FLSS); and quality of life (QoL), depression, anxiety, and satisfaction scores. Infections were classified as “confirmed” if purulent material was extracted and/or an organism cultured. Infections were classified as “possible” if only clinical signs were present without purulent discharge or microbiologic confirmation. Results: Year 4 results were available for 5 pilot and 27 full-scale study participants. Delayed complications included 5 confirmed infections (15.6%), 3 possible infections (9.4%), nodules (25%), and bleeding (3%). No significant changes were observed between years 2 to 4 in patient-graded FLSS, QoL, depression, and anxiety scores. Whereas 94% of participants were satisfied with their overall treatment, only 69% were satisfied with PAIG treatment specifically. Conclusion: Even though PAIG treatment was associated with delayed complications including high rates of infection and nodules, most patients were satisfied with the treatment.

Cost of surgical intervention for reconstructive therapy of HIV-associated facial lipoatrophy

This study aims to assess direct cost of reconstructive interventions with facial fillers for treatment of HIV (human immunodeficiency virus)-associated facial lipoatrophy (FLA). Evaluation was performed on data from patients enrolled in one arm of a comparative study of immediate versus delayed reconstructive treatment of facial lipoatrophy. Median costs were standardized for efficacy, estimated using data reported by physicians and patient reported outcomes. The variations of the results were evaluated with a sensitivity analysis. Evaluation was performed on 66 patients characterized by significant differences in terms of severity of FLA. Total cost resulted of €140,416.15, with a median cost per patient of €2126.04 (interquartile range [IQR]: 1599–2822). Taking into consideration severity of disease, median costs were €1641.67 (IQR: 1326.67–2126.04) and 2557.12 (IQR: 1939.34–2872.04) (P = 0.0) respectively for patients with low and high severity scores at baseline. Significant differences in term of cost-effectiveness ratios were also found between patients with different severity of FLA, and sensitivity analysis showed that these ratios increase with higher severity scores at baseline and vary widely depending on the costs of filler. Although these results cannot be considered representative because of important limitations, the present study suggests the severity of disease as an important determinant of costs.

Surgical correction of HIV-associated facial lipoatrophy

Surgical correction of HIV-associated facial lipoatrophy

Early and late complications of polyalkylimide gel (Bio-Alcamid)®

This case report summarises early and late of complications that have developed inpatients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describes the management strategy employed to treat the most serious of these cases.

An Economic Evaluation of Treatments for HIV-Associated Facial Lipoatrophy: A Cost-Utility Analysis

HIV-associated facial lipoatrophy (FLA) is a stigmatizing hallmark for persons living with HIV [PLWH], and can lead to poor social functioning, social isolation, and reduced labour force participation. Treatments for this condition are prohibitively expensive and are not publicly insured in the Province of Ontario, Canada. Information gleaned from an economic evaluation of treatments for FLA could inform policy decision making concerning coverage. Decision-analytic techniques were used to estimate the lifetime incremental costs and quality-adjusted life years (QALYs) gained from use of either Poly-l-lactic acid or Polyalkylimide gel from the perspectives of society and the Ontario Ministry of Health. Disease progression probabilities and utilities were derived from the literature. Costs were obtained through interviews with product distributors and physicians who perform these treatments. Costs were valued in 2009 Canadian Dollars. Costs and outcomes were discounted annually at 3%. Treatments using Polyalkylimide gel exhibit such a cost advantage over those using Poly-l-lactic acid that they more than compensate for the health-related quality of life advantages of Poly-l-lactic acid. From a Ministry of Health perspective, the incremental cost-utility ratios for Polyalkylimide gel or Poly-l-lactic acid compared to no treatment were $45,457 CAD or $57,352 CAD per QALY, respectively, $1.00 CAD = $0.876 USD). From a societal perspective the equivalent ratios were $48,583 CAD and $66,608 CAD respectively. These findings were not altered in the sensitivity analyses. FLA treatments for PLWH enhance QALYs and meet conventional cost-utility thresholds. The incremental cost per QALY for Polyalkylimide gel was lower than that for Poly-l-lactic acid.

Hyaluronic Acid New Formulation: Experience in HIV-Associated Facial Lipoatrophy

Hyaluronic Acid New Formulation: Experience in HIV-Associated Facial Lipoatrophy

Retreatment with Injectable Poly-l-Lactic Acid for HIV-Associated Facial Lipoatrophy: 24-Month Extension of the Blue Pacific Study

Retreatment with Injectable Poly-l-Lactic Acid for HIV-Associated Facial Lipoatrophy: 24-Month Extension of the Blue Pacific Study

Long-term efficacy and safety of polyalkylimide gel for the treatment of HIV-associated lipoatrophy

The long-term safety and efficacy of products used in the correction of HIV-associated facial lipoatrophy (FLA) are largely unknown. The purpose of this study was to describe the long-term efficacy and safety of polyalkylimide gel (PAIG) in the treatment of HIV-associated FLA. In this open-label, randomized, single-center study, 31 HIV-positive individuals (median age 48 years (interquartile ranges (IQR) 45, 55, 97% male) with FLA were randomized to immediate (week 0 and six) or delayed (week 12 and 18) PAIG injections. Week 96 endpoints included change in FLA severity scores (FLSS) (five-point scale), proportion of patients with adverse events, and changes in quality of life, depression and anxiety using validated surveys. Results at week 96 were available for 28 patients. Adverse events, including swelling, redness, bruising and pain, were mild, and resolved after a median of three days following the injection. At week 96, median changes in physician and patient FLSS scores were −2 (IQR −3, −1; p<0.001 vs. baseline) and −2 (IQR −2, −1; p<0.001 vs. baseline), respectively. Physician and patient FLSS scores were not significantly different between the groups at week 96. Significant improvements in patient's anxiety (p<0.001), depression (p<0.001) and mental health (p=0.01) were observed from baseline to week 96. In conclusion, treatment with PAIG was associated with sustained improvements in both the physical and psychological components of FLA through 96 weeks of follow-up.

Immediate versus Delayed Surgical Intervention for Reconstructive Therapy of HIV-Associated Facial Lipoatrophy: A Randomized Open-Label Study

We assessed the safety and efficacy of reconstructive therapy with facial fillers for the treatment of HIV-associated facial lipoatrophy (FLA) through a randomized, controlled, open-label single-center study. A total of 134 HIV-infected patients with severe FLA were randomly assigned to receive immediate (67 patients) or delayed (67 patients) facial injections of poly-l-lactic acid (PLA) or polyacrylamide gel (PAIG). Outcome measures included changes in physician and patient FLA severity scale, adverse events, and changes in health-related quality of life (HRQoL) and anxiety using validated measures. The mean average study follow-up was 27 weeks for the immediate and 25 weeks for the delayed subjects. Adverse events were mild and resolved after a mean of 4 days. Compared to patients randomized to the delayed treatment group, patients assigned to the immediate treatment group had significantly lower physician-rated (0.0 versus -3.0; p < 0.0001) and patient-rated (0.1 versus -1.8; p < 0.0001) FLA severity scores. By contrast, measures exploring HRQoL and anxiety did not show any significant difference between patients randomized to the immediate and deferred groups. Reconstructive therapy with facial fillers was effective and safe and led to significant improvements in FLA severity. However, no significant gains in HRQoL, relational and psychological consequences of body changes, and anxiety-related concerns were observed. Studies should be performed to identify patients who could maximally benefit from filling interventions for FLA.

A Systematic Review of Permanent and Semipermanent Dermal Fillers for HIV-Associated Facial Lipoatrophy

The objective of this study was to assess the safety and efficacy of injectable semipermanent and permanent dermal fillers, compared to other facial augmentation techniques, for the management of facial lipoatrophy as a result of highly active antiretroviral therapy (HAART) for HIV infection through a systematic review of the literature. A systematic search strategy was used to retrieve relevant studies. Inclusion of articles was by the application of a predetermined protocol, independent assessment by two reviewers, and a final consensus decision. One randomized controlled trial (RCT), one pseudo-RCT, two nonrandomized comparative studies, and seven case series were included for review. Injections with permanent and semipermanent dermal fillers improved subjective ratings of appearance and resulted in high patient satisfaction. Although short-term safety appeared favorable, of the seven studies that reported lumps, three studies reported these events in more than 40% of patients. Long-term safety data were lacking. Evidence suggests that permanent and semipermanent dermal fillers achieve their objective, which is to decrease the visible effects of HIV-associated facial lipoatrophy, with high patient satisfaction. Safety appears favorable in the short term, but further studies are required to determine long-term outcomes.

Cost consequences of HIV-associated lipoatrophy

HIV-associated lipoatrophy may affect up to 35% of patients who have received antiretroviral (ARV) regimens for more than one year, and may result in depression, social isolation, and career barriers. Interventions including the injection of dermal fillers for restoration of facial fat loss are being used for treating HIV-associated lipoatrophy. Since reimbursement is often lacking, patients must consider the pros and cons of such interventions, weighed against the other costs of daily life. The primary goal of the study is to provide reliable estimates of the costs of treating HIV-associated lipoatrophy, specifically facial lipoatrophy. Costs are provided for a single site and are estimated from published studies reporting administration patterns of dermal fillers, publicly available list prices, and physician service fees for similar subcutaneous injections of the face. Fourteen studies were identified that reported experience with five dermal fillers used to treat HIV-associated facial lipoatrophy: poly-L-lactic acid, calcium hydroxylapatite, polyalkylimide gel, hyaluronic acid, and silicone oil. Typical courses involve four physician visits, but could vary from 1 to 13. The cost of a course of dermal filler treatment at a single site ranges across four products (all other than hyaluronic acid) from $3690 to $16,544, and is typically not covered by the payers. Physician fees for an entire course of similar outpatient procedures reimbursed by insurers are approximately $500, and may vary according to location, specialty, and market conditions. These procedures need to be repeated per site injected with intervals of 1–3 years. Treatment of HIV-associated lipoatrophy may represent a considerable out-of-pocket expense for many patients with HIV. This could have implications for deciding whether to undergo a restorative procedure, which procedure to undergo, and whether to pursue other options that may include switching ARV regimens.