title: Immediate versus delayed polyalkylimide gel injections to correct facial lipoatrophy in HIV-positive patients.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of polyalkylimide gel (PAIG) in the treatment of HIV-associated facial lipoatrophy.
  
  
  METHODS
  A randomized, open-label, single-centre study.
  
  
  METHODS
  HIV-positive individuals with facial lipoatrophy (based on physician assessment) were randomly assigned to immediate (weeks 0 and 6) or delayed (weeks 12 and 18) PAIG injections administered into the subcutaneous plane. Outcome measures included a change in facial lipoatrophy severity scores (five-point scale), adverse events, photographic assessment, and changes in quality of life (QoL), depression and anxiety using validated surveys.
  
  
  RESULTS
  Thirty-one patients (median age 48 years, 97% male) were enrolled and completed 48 weeks of follow-up. Overall, the median volume of product injected bilaterally was 16.0 ml. Adverse events, including swelling, redness, bruising and pain, were mild, and resolved after a median of 3 days. There were no cases of necrosis, nodules or infection. Compared with patients randomly assigned to delayed treatment, patients in the immediate therapy group had significantly lower physician-rated facial lipoatrophy scores (0 versus 2; P < 0.0001), improved QoL (P = 0.01), and lower anxiety (P = 0.02) at week 12. At week 48, median physician and patient facial lipoatrophy scores were 0 and 1, respectively, for the entire cohort, and were not significantly different between the groups. Significant improvements in patient anxiety (P = 0.001) and depression (P = 0.01) were observed from baseline to week 48.
  
  
  CONCLUSIONS
  Treatment with PAIG was effective and safe and led to improvements in facial lipoatrophy grading, QoL, anxiety and depression scores in HIV-infected patients with facial lipoatrophy.
authors.affiliation: Maple Leaf Medical Clinic, 70 Carlton Street, Toronto, Ontario, Canada. monas.loutfy@wchospital.ca
authors.forename: Mona R
authors.initials: MR
authors.lastname: Loutfy
authors.forename: Janet M
authors.initials: JM
authors.lastname: Raboud
authors.forename: Tony
authors.initials: T
authors.lastname: Antoniou
authors.forename: Colin
authors.initials: C
authors.lastname: Kovacs
authors.forename: Sandy
authors.initials: S
authors.lastname: Shen
authors.forename: Roberta
authors.initials: R
authors.lastname: Halpenny
authors.forename: Darlene
authors.initials: D
authors.lastname: Ellenor
authors.forename: Davia
authors.initials: D
authors.lastname: Ezekiel
authors.forename: Alice
authors.initials: A
authors.lastname: Zhao
authors.forename: Francis
authors.initials: F
authors.lastname: Beninger
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D001007:Anxiety / Q000150:complications; D004334:Drug Administration Schedule; D005145:Face / Q000473:pathology*; D005260:Female; D005782:Gels; D039682:HIV-Associated Lipodystrophy Syndrome / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000180:Acrylic Resins; C470344:Bio-Alcamid; D005782:Gels