Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients.

BACKGROUND: Facial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV) drugs. Poly-L-lactic acid (PLLA) acid has been used to correct facial lipoatrophy in people with HIV since 2004 both in Europe and the United States. The objective of this study was to establish, in real life conditions and in a large sample, the safety of PLLA (New Fill®, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients. METHODS: A longitudinal study was conducted between 2005 and 2008 in France. Data from 4,112 treatment courses (n = 4,112 patients) and 15,665 injections sessions (1 to 5 injection sessions per treatment course) were gathered by 200 physicians trained in the use of PLLA. RESULTS: The average age of patients (88.3% males) treated for lipoatrophy was 47.1 ± 8.1 years (Mean ± SD); 91.2% of patients had been receiving ARV treatment for 10.9 (±4.2) years; CD4 T-cell count was 535 ± 266 cells/mm3. The duration of facial lipoatrophy was 5 ± 2.8 years and the severity was such that 47.3% of patients required five injection sessions of PLLA and 81.9% of the sessions required two vials of the preparation. The final visit, scheduled two months after the last injection session, was attended by 66.0% of patients (n = 2,713). 48 treatment courses (2.8%) were discontinued due to adverse events (AEs). The overall incidence of AEs per course was 18.8%. Immediate AEs, bleeding (3.4%), bruising (2.3%), pain (2.0%), redness at injection site (1.6%), and swelling of the face (0.7%), occurred in 15.4% of courses and 7.0% of sessions (usually during the first session). Non-immediate AEs, mainly nodules (5.7%), inflammation (0.7%), granuloma (0.3%), discolouration (0.2%), and skin hypertrophy (0.1%), occurred in 6.7% of courses. Non-immediate AEs occurred within a time ranging from 21 days (inflammation) to 101 days (granuloma) and all but three of the 13 cases of granuloma resolved. Product efficacy was rated satisfactory by 95% of the patients and physicians. CONCLUSIONS: This study demonstrated, in real-life conditions and on a large sample, that PLLA injections were feasible, efficient, and safe when performed by trained physicians.

A longitudinal evaluation of the impact of a polylactic acid injection therapy on health related quality of life amongst HIV patients treated with anti-retroviral agents under real conditions of use.

BACKGROUND: Many HIV patients receiving antiretroviral treatment develop lipodystrophy. NEW-FILL® is a polylactic acid injected to treat facial lipoatrophy. The objectives of this study were to describe (1) change in quality of life (QoL) of HIV patients treated with NEW-FILL® in the management of facial lipoatrophy; (2) efficacy of NEW-FILL® using facial photographs and (3) a patient-reported "Overall Treatment Effect" (OTE) scale; and (4) safety of NEW-FILL®. METHODS: Doctors from 13 treatment centres recruited 230 HIV patients to receive up to 5 sessions of NEW-FILL® injections. Patients self-reported QoL with the ABCD questionnaire before the first set of injections, at 2 months and at 12 to 18 months after the last session of injections. Efficacy was evaluated at each interval through photographs and OTE scale. Safety was evaluated via Case Report Form (CRF) data. RESULTS: 64.4% of patients reported QoL improvements of >10% at 2 months, and 58.8% at 12-18 months. Lipoatrophy grades improved at each visit ("no lipoatrophy" or "limited lipoatrophy": 20.3% at inclusion, 77.4% at 2 months, 58.4% at 12-18 months). Average OTE scores of 5.3 and 5.0 at 2 and 12-18 months indicated "moderate improvement". Minimum Important Difference (MID) in QoL score was 7.1 points at 2 months; 7.4 points at 12-18 months. For 911 injection sessions performed, 3.4% resulted in "immediate" adverse events, 7% in "non-immediate" events, and 1.7% in "other" events. CONCLUSIONS: Improvements to quality of life and diminished lipoatrophy visibility were observed in the months immediately following NEW-FILL® treatment and were maintained 12-18 months post-treatment. Most adverse events were mild and transient. ABCD MID thresholds provide clinicians with means to assess the impact of lipoatrophy therapies on QoL.

Treatment of facial lipoatrophy with intradermal injections of polylactic acid in HIV-infected patients.

BACKGROUND: This study assessed the safety and efficacy of intradermal injections of polylactic acid (PLA) in patients with facial lipoatrophy under antiretroviral therapy. METHODS: In a prospective open-label study, PLA was injected in both cheeks every 2 weeks. The primary efficacy endpoint was the patient's self-perception of improvement as assessed by a visual analogue scale (VAS). Secondary endpoints included 3-dimensional photographs (3DP) to measure dermal thickness, quality of life (QoL) scores, and adverse events. RESULTS: Ninety-four patients received a median of 5 sets of injection in both cheeks. Median age was 43 years, and median CD4 cell count was 500/mm3. Median VAS score significantly increased from 3.4/10 at baseline to 6.8/10 at the end of the treatment procedure and was sustained at 7/10 at the end of follow-up (P < 0.0001 vs. baseline). Median dermal thickness increase was 2.3 mm at the end of follow-up. QoL scores remained unchanged. Seventeen patients needed further injections of PLA during a median follow-up of 12 months. Injections were well tolerated with only 1 serious adverse event (anaphylactic reaction) that necessitated treatment interruption. CONCLUSIONS: Injections of PLA improved patients' self-perception of facial lipoatrophy, with a good safety profile. The benefit of the procedure, however, decreased with time.