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Wiley InterScience

HIV Medicine

Volume 10 Issue 3, Pages 163 - 172

Published Online: 4 Jan 2009

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ORIGINAL RESEARCH

Poly-l-lactic acid for HIV-1 facial lipoatrophy: 48-week follow-up

D Carey ¹ , D Baker ² , K Petoumenos ¹ , J Chuah ³ , GD Rogers ⁴ , J Watson ⁵ , DA Cooper ^1,6 , S Emery ¹ and A Carr ⁶ , for the FLASH Investigators ^*

¹ National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, NSW, Australia, ² East Sydney Doctors, Sydney, NSW, Australia, ³ Gold Coast Sexual Health Clinic, Miami, QLD, Australia, ⁴ Griffith University, Gold Coast, QLD, Australia, ⁵ National Association of People living with HIV/AIDS, Sydney, NSW, Australia and ⁶ St Vincent's Hospital, Sydney, NSW, Australia

Correspondence: Dr Dianne Carey, National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, 376 Victoria Street, Sydney 2010, NSW, Australia. Tel: +61 2 9385 0900; fax: +61 2 9385 0910; e-mail: dcarey@nchecr.unsw.edu.au

^*See Appendix A.

KEYWORDS

HIV • lipoatrophy • poly-l-lactic acid

ABSTRACT

Objectives

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 cm³ (95% CI−1 to 29 cm³; 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.

Accepted 19 August 2008

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1468-1293.2008.00667.x About DOI