title: Poly-l-lactic acid for HIV-1 facial lipoatrophy: 48-week follow-up.
abstract: OBJECTIVE
  Poly-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.
  
  
  METHODS
  HIV-infected lipoatrophic adults were randomized to four open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n=50) or from week 24 (deferred group, n=50). Endpoints included FSTV assessed by computed tomography, facial lipoatrophy severity, quality of life (QoL) and safety. Analyses were by intention to treat.
  
  
  RESULTS
  Between 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=0.007] and base of nasal septum levels (mean 0.4 mm; 95% CI 0.1-0.8; P=0.021), but not in untreated areas (P=0.79 and P=0.24). PLA durability assessed at week 48 in immediate group participants showed a mean change in FSTV of 14 cm(3) (95% CI-1 to 29 cm(3); P=0.060) and increased tissue depth at the maxillary (P<0.0001), base of nasal septum (P<0.0001) and mandibular (P=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=0.027). Subcutaneous injection-site nodule incidence at 48 weeks was 10%.
  
  
  CONCLUSIONS
  PLA 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.
authors.affiliation: National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, NSW, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Carey
authors.forename: D
authors.initials: D
authors.lastname: Baker
authors.forename: K
authors.initials: K
authors.lastname: Petoumenos
authors.forename: J
authors.initials: J
authors.lastname: Chuah
authors.forename: G D
authors.initials: GD
authors.lastname: Rogers
authors.forename: J
authors.initials: J
authors.lastname: Watson
authors.forename: D A
authors.initials: DA
authors.lastname: Cooper
authors.forename: S
authors.initials: S
authors.lastname: Emery
authors.forename: A
authors.initials: A
authors.lastname: Carr
mesh_terms: D000328:Adult; D003357:Cosmetic Techniques; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D015497:HIV-1; D039682:HIV-Associated Lipodystrophy Syndrome / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007279:Injections, Subcutaneous; D019344:Lactic Acid / Q000008:administration & dosage*; D008297:Male; D011091:Polyesters; D011108:Polymers / Q000008:administration & dosage*; D011788:Quality of Life / Q000523:psychology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)