Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients
Identifieur interne : 000A69 ( Pmc/Curation ); précédent : 000A68; suivant : 000A70Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients
Auteurs : Martin Duracinsky [France] ; Pascale Leclercq [France] ; Susan Herrmann ; Marie-Odile Christen [France] ; Marc Dolivo [France] ; Cécile Goujard [France] ; Olivier Chassany [France]Source :
- BMC Infectious Diseases [ 1471-2334 ] ; 2014.
Abstract
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.
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.
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.
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.
The online version of this article (doi:10.1186/1471-2334-14-474) contains supplementary material, which is available to authorized users.
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DOI: 10.1186/1471-2334-14-474
PubMed: 25178390
PubMed Central: 4160543
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Susan Herrmann<affiliation><nlm:aff id="Aff3">Institute for Immunology and Infectious Diseases, Murdoch University, Perth, Western Australia Australia</nlm:aff><wicri:noCountry code="subfield">Western Australia Australia</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety of poly-L-lactic acid (New-Fill<sup>®</sup>) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients</title><author><name sortKey="Duracinsky, Martin" sort="Duracinsky, Martin" uniqKey="Duracinsky M" first="Martin" last="Duracinsky">Martin Duracinsky</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Bicêtre Hospital, Internal Medicine and Clinical Immunology, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit, Paris, & AP-HP, Le Kremlin-Bicêtre Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bicêtre Hospital, Internal Medicine and Clinical Immunology, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit, Paris, & AP-HP, Le Kremlin-Bicêtre Paris</wicri:regionArea></affiliation></author><author><name sortKey="Leclercq, Pascale" sort="Leclercq, Pascale" uniqKey="Leclercq P" first="Pascale" last="Leclercq">Pascale Leclercq</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Grenoble University hospital, Michallon hospital, Information and Treatment Centres for Human Immunodeficiency, BP 217, 38043, CEDEX 09 Grenoble, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Grenoble University hospital, Michallon hospital, Information and Treatment Centres for Human Immunodeficiency, BP 217, 38043, CEDEX 09 Grenoble</wicri:regionArea></affiliation></author><author><name sortKey="Herrmann, Susan" sort="Herrmann, Susan" uniqKey="Herrmann S" first="Susan" last="Herrmann">Susan Herrmann</name><affiliation><nlm:aff id="Aff3">Institute for Immunology and Infectious Diseases, Murdoch University, Perth, Western Australia Australia</nlm:aff><wicri:noCountry code="subfield">Western Australia Australia</wicri:noCountry></affiliation></author><author><name sortKey="Christen, Marie Odile" sort="Christen, Marie Odile" uniqKey="Christen M" first="Marie-Odile" last="Christen">Marie-Odile Christen</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Institut Behavior, 27 avenue Marceau, 75116 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Behavior, 27 avenue Marceau, 75116 Paris</wicri:regionArea></affiliation></author><author><name sortKey="Dolivo, Marc" sort="Dolivo, Marc" uniqKey="Dolivo M" first="Marc" last="Dolivo">Marc Dolivo</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Association des Œuvres Sociales du Ministère des Affaires Etrangères, 57 Boulevard des Invalides, 75007 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Association des Œuvres Sociales du Ministère des Affaires Etrangères, 57 Boulevard des Invalides, 75007 Paris</wicri:regionArea></affiliation></author><author><name sortKey="Goujard, Cecile" sort="Goujard, Cecile" uniqKey="Goujard C" first="Cécile" last="Goujard">Cécile Goujard</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Bicêtre Hospital, Internal Medicine and Clinical Immunology, & University Paris Sud, Le Kremlin-Bicêtre Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bicêtre Hospital, Internal Medicine and Clinical Immunology, & University Paris Sud, Le Kremlin-Bicêtre Paris</wicri:regionArea></affiliation></author><author><name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Department of Clinical Research, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit & AP-HP, Saint-Louis Hospital, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Research, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit & AP-HP, Saint-Louis Hospital, 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first="Martin" last="Duracinsky">Martin Duracinsky</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Bicêtre Hospital, Internal Medicine and Clinical Immunology, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit, Paris, & AP-HP, Le Kremlin-Bicêtre Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bicêtre Hospital, Internal Medicine and Clinical Immunology, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit, Paris, & AP-HP, Le Kremlin-Bicêtre Paris</wicri:regionArea></affiliation></author><author><name sortKey="Leclercq, Pascale" sort="Leclercq, Pascale" uniqKey="Leclercq P" first="Pascale" last="Leclercq">Pascale Leclercq</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Grenoble University hospital, Michallon hospital, Information and Treatment Centres for Human Immunodeficiency, BP 217, 38043, CEDEX 09 Grenoble, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Grenoble University hospital, Michallon hospital, Information and Treatment Centres for Human Immunodeficiency, BP 217, 38043, CEDEX 09 Grenoble</wicri:regionArea></affiliation></author><author><name sortKey="Herrmann, Susan" sort="Herrmann, Susan" uniqKey="Herrmann S" first="Susan" last="Herrmann">Susan Herrmann</name><affiliation><nlm:aff id="Aff3">Institute for Immunology and Infectious Diseases, Murdoch University, Perth, Western Australia Australia</nlm:aff><wicri:noCountry code="subfield">Western Australia Australia</wicri:noCountry></affiliation></author><author><name sortKey="Christen, Marie Odile" sort="Christen, Marie Odile" uniqKey="Christen M" first="Marie-Odile" last="Christen">Marie-Odile Christen</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Institut Behavior, 27 avenue Marceau, 75116 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Behavior, 27 avenue Marceau, 75116 Paris</wicri:regionArea></affiliation></author><author><name sortKey="Dolivo, Marc" sort="Dolivo, Marc" uniqKey="Dolivo M" first="Marc" last="Dolivo">Marc Dolivo</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Association des Œuvres Sociales du Ministère des Affaires Etrangères, 57 Boulevard des Invalides, 75007 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Association des Œuvres Sociales du Ministère des Affaires Etrangères, 57 Boulevard des Invalides, 75007 Paris</wicri:regionArea></affiliation></author><author><name sortKey="Goujard, Cecile" sort="Goujard, Cecile" uniqKey="Goujard C" first="Cécile" last="Goujard">Cécile Goujard</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Bicêtre Hospital, Internal Medicine and Clinical Immunology, & University Paris Sud, Le Kremlin-Bicêtre Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bicêtre Hospital, Internal Medicine and Clinical Immunology, & University Paris Sud, Le Kremlin-Bicêtre Paris</wicri:regionArea></affiliation></author><author><name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Department of Clinical Research, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit & AP-HP, Saint-Louis Hospital, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Research, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit & AP-HP, Saint-Louis Hospital, Paris</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Infectious Diseases</title><idno type="eISSN">1471-2334</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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<sup>®</sup>, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients.</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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.</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/1471-2334-14-474) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Carr, A" uniqKey="Carr A">A Carr</name></author><author><name sortKey="Samaras, K" uniqKey="Samaras K">K Samaras</name></author><author><name sortKey="Thorisdottir, A" uniqKey="Thorisdottir A">A Thorisdottir</name></author><author><name sortKey="Kaufmann, Gr" uniqKey="Kaufmann G">GR Kaufmann</name></author><author><name sortKey="Ghisholm, Dj" uniqKey="Ghisholm D">DJ 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Infect Dis</journal-id><journal-id journal-id-type="iso-abbrev">BMC Infect. Dis</journal-id><journal-title-group><journal-title>BMC Infectious Diseases</journal-title></journal-title-group><issn pub-type="epub">1471-2334</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25178390</article-id><article-id pub-id-type="pmc">4160543</article-id><article-id pub-id-type="publisher-id">3780</article-id><article-id pub-id-type="doi">10.1186/1471-2334-14-474</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>Safety of poly-L-lactic acid (New-Fill<sup>®</sup>) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Duracinsky</surname><given-names>Martin</given-names></name><address><email>duracinsky.m@gmail.com</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Leclercq</surname><given-names>Pascale</given-names></name><address><email>PLeclercq@chu-grenoble.fr</email></address><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Herrmann</surname><given-names>Susan</given-names></name><address><email>s.herrmann@murdoch.edu.au</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Christen</surname><given-names>Marie-Odile</given-names></name><address><email>christen.marieodile3@gmail.com</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Dolivo</surname><given-names>Marc</given-names></name><address><email>marc.dolivo1@wanadoo.fr</email></address><xref ref-type="aff" rid="Aff5"></xref></contrib><contrib contrib-type="author"><name><surname>Goujard</surname><given-names>Cécile</given-names></name><address><email>cecile.goujard@bct.aphp.fr</email></address><xref ref-type="aff" rid="Aff6"></xref></contrib><contrib contrib-type="author"><name><surname>Chassany</surname><given-names>Olivier</given-names></name><address><email>olivier.chassany@drc.aphp.fr</email></address><xref ref-type="aff" rid="Aff7"></xref></contrib><aff id="Aff1"><label></label>Bicêtre Hospital, Internal Medicine and Clinical Immunology, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit, Paris, & AP-HP, Le Kremlin-Bicêtre Paris, France</aff><aff id="Aff2"><label></label>Grenoble University hospital, Michallon hospital, Information and Treatment Centres for Human Immunodeficiency, BP 217, 38043, CEDEX 09 Grenoble, France</aff><aff id="Aff3"><label></label>Institute for Immunology and Infectious Diseases, Murdoch University, Perth, Western Australia Australia</aff><aff id="Aff4"><label></label>Institut Behavior, 27 avenue Marceau, 75116 Paris, France</aff><aff id="Aff5"><label></label>Association des Œuvres Sociales du Ministère des Affaires Etrangères, 57 Boulevard des Invalides, 75007 Paris, France</aff><aff id="Aff6"><label></label>Bicêtre Hospital, Internal Medicine and Clinical Immunology, & University Paris Sud, Le Kremlin-Bicêtre Paris, France</aff><aff id="Aff7"><label></label>Department of Clinical Research, University Paris Diderot, Sorbonne Paris Cité, EA REMES, Patient Reported Outcomes Unit & AP-HP, Saint-Louis Hospital, Paris, France</aff></contrib-group><pub-date pub-type="epub"><day>1</day><month>9</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>9</month><year>2014</year></pub-date><pub-date pub-type="collection"><year>2014</year></pub-date><volume>14</volume><elocation-id>474</elocation-id><history><date date-type="received"><day>12</day><month>4</month><year>2014</year></date><date date-type="accepted"><day>19</day><month>8</month><year>2014</year></date></history><permissions><copyright-statement>© Duracinsky et al.; licensee BioMed Central Ltd. 2014</copyright-statement><license license-type="open-access"><license-p>This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0">http://creativecommons.org/licenses/by/4.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>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<sup>®</sup>, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients.</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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.</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/1471-2334-14-474) contains supplementary material, which is available to authorized users.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>HIV</kwd><kwd>Lipoatrophy</kwd><kwd>Poly-L-lactic acid</kwd><kwd>PLLA</kwd><kwd>Safety</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2014</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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