Background: Polylactic acid (PLA) injections for treatment of HIV-related facial lipoatrophy has shown early promise with good toleration (Perry 2004; Burgess et al 2005), although multiple studies have cited subcutaneous papule (often erroneously called subcutaneous nodules) formation as a possible side effect (Valantin, Aubron-Olivier et al. 2003). We examined papule formation in HIV+ facial lipoatrophic patients treated with PLA injections. Methods:
This project was a single-center open-label treatment trial with target enrollment of 25 HIV+ patients with moderate to severe facial lipoatrophy. Patients were given monthly injections of PLA until provider and patient were satisfied. Resultant papules formed were tallied and photographed at treatment visits. Ten minute intervals of massage over involved areas post-procedure and twice a day for four weeks were added to protocol after study initiation. Results: 24 HIV+ male patients received PLA injections. All results reported are medians with 25-75% quartile ranges. Median age, CD4+ count and viral load were 50.5 years (33 to 72 years), 487 cell/mm³ (306.5 - 786 cell/mm³), and 822 copies/mL (163 - 8675 copies/mL). Patients received 6.5 treatments (4.25 - 9.75 treatments) and had a total of 55.5 cc (84.75 to 39 cc) PLA injected. Median papule formation overall was 0.033 papules/cc PLA injected (0 to 0.11 papules/cc PLA injected ). Median papule formation prior to vs. after massage was significantly different at 0.14 papule/cc (0 to 0.25 papule/cc), vs 0.0 (0.0 to 0.02724) p <0.001 respectively. Notably, the five patients enrolled after massage was added to protocol had a total of 1 subcutaneous papule, or 0.0064 papules/cc PLA injected. No adverse events were reported. Conclusions: Massaging the involved area immediately after injection and daily thereafter for at least four weeks post treatment significantly decreases incidence of subcutaneous papule formation.