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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