A randomized, multicenter, open-label study of poly-L-lactic acid for HIV-1 facial lipoatrophy.
BACKGROUND
Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints.


METHODS
HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 51) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat.


RESULTS
At week 24, mean changes in FSTV were 0 cm3 in the intermediate group and -10 cm3 in the deferred group (between-group difference of 10 [95% confidence interval (CI): -7 to 28] cm3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% CI: 1.6 to 2.9]; P < 0.0001) and base of the nasal septum (1.0 mm [95% CI: 0.3 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days.


CONCLUSIONS
PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.
Carey
Dianne L
DL
National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia. dcarey@nchecr.unsw.edu.au
Baker
David
D
Rogers
Gary D
GD
Petoumenos
Kathy
K
Chuah
John
J
Easey
Nicole
N
Machon
Kirsty
K
Cooper
David A
DA
Emery
Sean
S
Carr
Andrew
A
D005145:Face / Q000000981:diagnostic imaging / Q000473:pathology*; D005260:Female; D039682:HIV-Associated Lipodystrophy Syndrome / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D019344:Lactic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers / Q000009:adverse effects / Q000627:therapeutic use*; D011859:Radiography; D012720:Severity of Illness Index; D050151:Subcutaneous Fat / Q000473:pathology*
D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)