14th Conference on Retroviruses and Opportunistic Infections Los Angeles, California - February 25-28, 2007

Conf Retrovir Opportunistic Infect 2007 Feb 25-28;14: (abstract no. 40)

Dianne Carey¹, D Baker², N Easey³, K Petoumenos¹, S Emery¹, J Chuah⁴, K Machon⁵, G Rogers⁶, D Cooper^1,3, D Cooper^1,3, A Carr³, and for the Facial Lipoatrophy Study in HIV (FLASH) Investigators
¹Natl Ctr for HIV Epidemiology and Clin Res, Univ of New South Wales, Australia; ²407 Doctors, Sydney, Australia; ³St Vincent's Hosp, Sydney, Australia; ⁴Gold Coast Sexual Hlth Clin, Miami, Australia; ⁵Natl Assn of People with HIV/AIDS, Sydney, Australia; and ⁶Secretariat of the Pacific Community, Noumea, New Caledonia

BACKGROUND: Facial lipoatrophy is disfiguring, can stigmatize, and can affect self-esteem, quality of life, and adherence to ART. Small studies have found poly-L-lactic acid injections to have acceptable safety and efficacy over 48 weeks, but no study was randomized and also included objective endpoints.

METHODS: HIV+ adults with moderate/severe facial lipoatrophy were randomised to 4 open-label poly-L-lactic acid treatments (5 mL per cheek) every 2 weeks from week 0 (IMM; n = 51), or 4 poly-L-lactic acid treatments after week 24 (DEF; n = 50). The primary endpoint was mean change from baseline in facial soft tissue volume (upper limit at mid-orbit; lower limit at angle of mandible) by spiral computed tomography (CT). The study had 80% power to detect a 25% difference in change in facial soft tissue volume between groups at week 24 by intention-to-treat analysis.

RESULTS: Mean changes in facial soft tissue volume at week 24 were 0 cm³ in the IMM group and –10 cm³ in the DEF group (between-group difference, 10 cm³ [95%CI –7, +28]; p = 0.24; +3%). Relative to the DEF group, the IMM group had a significantly greater between-group change in subcutaneous soft-tissue depth just inferior to the malar bone (2.2 mm; 95%CI 1.6, 2.9; p <0.0001; +19%) and just superior to the nasolabial folds (1.0 mm; 95%CI, 0.3, 1.6; p = 0.003; +4%), but not in untreated areas (mid-orbit, p = 0.9; angle of mandible; p = 0.21). Subjective facial lipoatrophy severity assessed by patient and physician improved significantly in IMM participants (p <0.0001). There was no change in peripheral fat mass (p = 0.63), total fat mass (p = 0.29), or lean body mass (p = 0.28) by DEXA. Poly-L-lactic acid treatment adherence was 99%. Poly-L-lactic acid treatment did not significantly impact HIV viral load (p = 0.57), CD4+ count (p = 0.54), or ART adherence (p = 0.70). The most common procedure/product adverse events were pain or discomfort (any grade, 79%), edema (66%; ≥25 mm diameter, 29%) and erythema (56%; ≥25 mm diameter, 22%). Median duration of treatment-related adverse events was 2 (IQR 1 to 3) days. No poly-L-lactic acid–related adverse event was dose-limiting or delayed treatment. Of 4 severe adverse events reported in 3 subjects, none was attributed to poly-L-lactic acid.

CONCLUSIONS: Although 4 facial injections of poly-L-lactic acid over 6 weeks in HIV-infected adults with facial lipoatrophy did not increase facial soft tissue volume overall, but prevented deterioration in injected areas. Poly-L-lactic acid injections were administered safely and were well tolerated. Objectively assessed relative increases in cheek subcutaneous thickness were less than reported in other studies.

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2007-02-25
40

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