Polyacrylamide Hydrogel Injection in the Management of Human Immunodeficiency Virus-Related Facial Lipoatrophy: Results of the LIPOPHILL Open-Label Study

Abstract

Combination antiretroviral therapy (cART) can cause potentially stigmatizing facial lipoatrophy. Encouraging preliminary results have been reported with 2.5% polyacrylamide hydrogel for facial reconstruction. The aim of this multicenter, open-label noncomparative pilot study was to evaluate the efficacy and safety of intradermal facial injections of polyacrylamide hydrogel in HIV-infected patients with severe facial lipoatrophy. The patients received between two and six injections every 4 weeks, according to the aesthetic results. Clinical efficacy was evaluated by means of facial ultrasonography and photography at baseline and months 6, 12, and 24. Adverse events, patient satisfaction, and quality of life were also assessed. One hundred and eleven patients were enrolled and received at least one injection. Mean cheek skin thickness was 9.7 mm [95% CI: 9.1 to 10.2] at baseline. It rose by an average of 4.4 mm [95% CI: 3.9 to 4.9; p<0.001] at month 12 and a further 0.87 mm [95% CI: 0.52 to 1.23; p<0.001] at month 24. The Overall Treatment Satisfaction scale showed an improvement in more than 88% of patients at all visits, based on the appreciations of the patients, their close relatives and physicians, and on independent assessment of facial photographs. Quality of life improved significantly over time, as shown by the lipodystrophy-specific ABCD scale. No severe adverse effects related to the polyacrylamide hydrogel were noted. Polyacrylamide hydrogel injections were well tolerated and significantly improved the aesthetic aspect and quality of life of HIV-infected patients with facial lipoatrophy.

High Prevalence and Impact on the Quality of Life of Facial Lipoatrophy and Other Abnormalities in Fat Tissue Distribution in HIV-Infected Patients Treated with Antiretroviral Therapy

“…This is consistent with previous data showing the negative impact of LD on QoL. 10,11,[29][30][31] The PRO part of the study raised a good level of interest, as 95% of the questionnaires were completed. This type of assessment should be more routinely used when monitoring LD as it provides a personalized insight on the impact of symptoms on the patient's life.…”

“…These correlations were higher than those reported in non-HIV diseases. 31 This study has some limitations as it is cross-sectional and does not use objective evaluation of LD, e.g., CT scan or DEXA. There may have been some degree of selection bias, as it is possible that the patients who agreed to participate were more concerned by lipodystrophy issues than those who did not.…”

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.…”

“…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] …”

Clinical data on injectable tissue fillers: a review

“…Product related [132] Prospective study (n = 290), 24 months follow-up # Treatment-emergent adverse events; product 18.3%, injection procedure 24.5%, injection-site nodules 8.3% and papules 8.6%…”