PMID- 25178390
OWN - NLM
STAT- MEDLINE
DCOM- 20141124
LR  - 20220317
IS  - 1471-2334 (Electronic)
IS  - 1471-2334 (Linking)
VI  - 14
DP  - 2014 Sep 1
TI  - Safety of poly-L-lactic acid (New-Fill(R)) in the treatment of facial lipoatrophy: 
      a large observational study among HIV-positive patients.
PG  - 474
LID - 10.1186/1471-2334-14-474 [doi]
LID - 474
AB  - 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(R), 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.
FAU - Duracinsky, Martin
AU  - Duracinsky M
AD  - University Paris Diderot, Sorbonne Paris Cite, EA REMES, Patient Reported 
      Outcomes Unit, Paris, & AP-HP, Bicetre Hospital, Internal Medicine and Clinical 
      Immunology, Le Kremlin-Bicetre, Paris, France. duracinsky.m@gmail.com.
FAU - Leclercq, Pascale
AU  - Leclercq P
FAU - Herrmann, Susan
AU  - Herrmann S
FAU - Christen, Marie-Odile
AU  - Christen MO
FAU - Dolivo, Marc
AU  - Dolivo M
FAU - Goujard, Cecile
AU  - Goujard C
FAU - Chassany, Olivier
AU  - Chassany O
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20140901
PL  - England
TA  - BMC Infect Dis
JT  - BMC infectious diseases
JID - 100968551
RN  - 0 (New-Fill)
RN  - 0 (Polyesters)
RN  - 0 (Polymers)
RN  - 33X04XA5AT (Lactic Acid)
RN  - 3OWL53L36A (Mannitol)
RN  - 459TN2L5F5 (poly(lactide))
RN  - 9004-34-6 (Cellulose)
SB  - IM
MH  - Adult
MH  - CD4 Lymphocyte Count
MH  - Cellulose/*therapeutic use
MH  - Face
MH  - Female
MH  - France
MH  - HIV Infections/complications/drug therapy
MH  - HIV-Associated Lipodystrophy Syndrome/*drug therapy
MH  - Humans
MH  - Lactic Acid/*therapeutic use
MH  - Longitudinal Studies
MH  - Male
MH  - Mannitol/*therapeutic use
MH  - Middle Aged
MH  - Polyesters
MH  - Polymers/therapeutic use
MH  - United States
PMC - PMC4160543
EDAT- 2014/09/03 06:00
MHDA- 2014/12/15 06:00
PMCR- 2014/09/01
CRDT- 2014/09/03 06:00
PHST- 2014/04/12 00:00 [received]
PHST- 2014/08/19 00:00 [accepted]
PHST- 2014/09/03 06:00 [entrez]
PHST- 2014/09/03 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
PHST- 2014/09/01 00:00 [pmc-release]
AID - 1471-2334-14-474 [pii]
AID - 3780 [pii]
AID - 10.1186/1471-2334-14-474 [doi]
PST - epublish
SO  - BMC Infect Dis. 2014 Sep 1;14:474. doi: 10.1186/1471-2334-14-474.