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PHA Better Than PLA for HIV Facial Atrophy at 96 Weeks, But More Painful
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51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 17-20, 2011, Chicago
Mark Mascolini
Patient satisfaction with polyacrylamide hydrogel (PHA) injections for HIV-related facial atrophy was slightly but significantly greater than with polylactic acid (PLA) injections after 48 and 96 weeks in a randomized open-label trial involving 148 people [1]. Cheek thickness at 96 weeks was significantly greater with PHA than with PLA. But blinded assessment of photographs detected no difference between the two remedies, and PHA injections were more painful than PLA injections.
In France PLA has been licensed to treat facial atrophy since 2001. ANRS investigators planned this noninferiority trial to compare outcomes with PHA versus PLA. All study participants were at least 18 years old and were taking antiretrovirals. No one had prior injection therapy for facial atrophy, and no one was taking stavudine. Everyone had a CD4 count above 100 and a normal coagulation test. The trial's primary outcome was patient satisfaction at week 48 assessed on a visual analog scale ranging from 0 to 10.
Median ages in the PLA and PHA groups were 48 and 47, and 96% and 91% were men. CD4 counts averaged 538 in the PLA arm and 528 in the PHA arm. About 90% of study participants had a viral load below 50 copies. In the PLA and PHA groups, the investigators rated lipoatrophy mild in 23% and 28%, moderate in 49% and 43%, and severe in 28% and 29%.
Median numbers of PLA and PHA injections were 6 and 5. Average injection volume per session averaged 9 mL with PLA and 4 mL with PHA. Ten people in the PLA group and 8 in the PHA group had additional injections after week 48.
In a last-observation-carried-forward analysis at week 48, average patient satisfaction was significantly greater with PHA than with PLA (7.5 versus 7.1, P = 0.0002). Satisfaction with PHA remained significantly greater at week 96 (6.9 versus 6.7, P = 0.003). However, blinded assessment of lipoatrophy photographs by the researchers at weeks 48 and 96 found no difference in improvement between the two injections (P > 0.99).
Although average cheek skinfold thickness improvement was greater with PHA than PLA at 48 weeks (+0.8 mm), this difference was not statistically significant (P = 0.21). But at week 96 the greater cheek thickness with PHA persisted and reached statistical significance compared with PLA (+1.2 mm, P = 0.038). Quality of life assessed on the MOS HIV scale did not differ significantly between study arms at week 48 or week 96.
Mean pain score during injections was significantly higher with PHA than with PLA (4 versus 3, P = 0.001). But the two therapies did not differ in rates of bleeding, hematoma, or vagal nerve malaise during injections. After injections, PLA and PHA did not differ in rates of edema, hematoma, pain, or subcutaneous nodules.
There were four serious adverse events with PHA (granuloma-like lesions) and none with PLA, but this difference stopped short of statistical significance (P = 0.12). The ANRS investigators suggested, though, that "long-term serious complications at the injection site are a concern with PHA."
Reference
1. Lafaurie M, Dolivo M, Porche R, et al. Polylactic acid (PLA) versus polyacrylamide hydrogel (PHA) injections for the treatment of facial lipoatrophy in HIV-infected patients: results of a randomized controlled trial (ANRS 132 smile) at week 96. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). September 17-20, 2011. Chicago. Abstract H1-1399a.
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