Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients
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 rea...
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| Veröffentlicht in: | BMC infectious diseases 2014-09, Vol.14 (1), p.474-474, Article 474 |
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| description | 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. |
| doi_str_mv | 10.1186/1471-2334-14-474 |
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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.</description><identifier>ISSN: 1471-2334</identifier><identifier>EISSN: 1471-2334</identifier><identifier>DOI: 10.1186/1471-2334-14-474</identifier><identifier>PMID: 25178390</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; CD4 Lymphocyte Count ; Cellulose - therapeutic use ; Clinical outcomes ; Data processing ; Face ; Female ; France ; HIV ; HIV Infections - complications ; HIV Infections - drug therapy ; HIV-Associated Lipodystrophy Syndrome - drug therapy ; Hospitals ; Human immunodeficiency virus ; Humans ; Immune system ; Immunology ; Internal medicine ; Lactic Acid - therapeutic use ; Longitudinal Studies ; Male ; Mannitol - therapeutic use ; Middle Aged ; Patients ; Physicians ; Polyesters ; Polymers - therapeutic use ; Quality of life ; United States</subject><ispartof>BMC infectious diseases, 2014-09, Vol.14 (1), p.474-474, Article 474</ispartof><rights>COPYRIGHT 2014 BioMed Central Ltd.</rights><rights>2014 Duracinsky et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.</rights><rights>Duracinsky et al.; licensee BioMed Central Ltd. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b652t-1ac86962db9bd3621343160a5e82940e7771a7db58218f6c4a1bbf4c7bececfe3</citedby><cites>FETCH-LOGICAL-b652t-1ac86962db9bd3621343160a5e82940e7771a7db58218f6c4a1bbf4c7bececfe3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160543/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160543/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,861,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25178390$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Duracinsky, Martin</creatorcontrib><creatorcontrib>Leclercq, Pascale</creatorcontrib><creatorcontrib>Herrmann, Susan</creatorcontrib><creatorcontrib>Christen, Marie-Odile</creatorcontrib><creatorcontrib>Dolivo, Marc</creatorcontrib><creatorcontrib>Goujard, Cécile</creatorcontrib><creatorcontrib>Chassany, Olivier</creatorcontrib><title>Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients</title><title>BMC infectious diseases</title><addtitle>BMC Infect Dis</addtitle><description>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.</description><subject>Adult</subject><subject>CD4 Lymphocyte Count</subject><subject>Cellulose - therapeutic use</subject><subject>Clinical outcomes</subject><subject>Data processing</subject><subject>Face</subject><subject>Female</subject><subject>France</subject><subject>HIV</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - drug therapy</subject><subject>HIV-Associated Lipodystrophy Syndrome - drug therapy</subject><subject>Hospitals</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Immune system</subject><subject>Immunology</subject><subject>Internal medicine</subject><subject>Lactic Acid - therapeutic use</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Mannitol - therapeutic use</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Physicians</subject><subject>Polyesters</subject><subject>Polymers - therapeutic use</subject><subject>Quality of life</subject><subject>United States</subject><issn>1471-2334</issn><issn>1471-2334</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqNk81u1DAQxyMEoh9w54QscWkPKfFXnHBAqlaUrrSiEoVeLceZ7Lpy4jR2FvYR-jI8BE-Gly1LFxWBfPBo_Jv_jGfsJHmBsxOMi_w1ZgKnhFKWYpYywR4l-1vX43v2XnLg_XWWYVGQ8mmyR3i0aJntJ7eXqoGwQq5BvbOrdJZapYPRSGlTo6MP8CU9M9Z-_3aMTIfCAlAYQIUWurCOaSKmLLKmdyoMrl-s3iCFrBrmgFzlYViqYFwXER_GeoVU67o5Op9epb3zJpgloD4SUc0_S540ynp4frcfJp_P3n2anKezi_fTyeksrXJOQoqVLvIyJ3VVVjXNCaaM4jxTHOLVWAZCCKxEXfGC4KLJNVO4qhqmRQUadAP0MHm70e3HqoVax9yDsrIfTKuGlXTKyN2Tzizk3C0li2k4o1FgshGojPuLwO6Jdq1cj0KuRxEtGScVVY7uyhjczQg-yNZ4DdaqDtzoJRacMkE4Ef9GeY4xKSkhEX31B3rtxiH2_yeVlUXGOf1NzZUFabrGxTr1WlSeclpywUqSR-rkASquGlqjXQeNif6dgOOdgMgE-BrmavReTi8__j97cbXLZhtWD877AZptr3Em1__goe6-vD_kbcCvh09_AEtPAgQ</recordid><startdate>20140901</startdate><enddate>20140901</enddate><creator>Duracinsky, Martin</creator><creator>Leclercq, Pascale</creator><creator>Herrmann, Susan</creator><creator>Christen, Marie-Odile</creator><creator>Dolivo, Marc</creator><creator>Goujard, Cécile</creator><creator>Chassany, Olivier</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QL</scope><scope>7T2</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20140901</creationdate><title>Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients</title><author>Duracinsky, Martin ; Leclercq, Pascale ; Herrmann, Susan ; Christen, Marie-Odile ; Dolivo, Marc ; Goujard, Cécile ; Chassany, Olivier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b652t-1ac86962db9bd3621343160a5e82940e7771a7db58218f6c4a1bbf4c7bececfe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>CD4 Lymphocyte Count</topic><topic>Cellulose - therapeutic use</topic><topic>Clinical outcomes</topic><topic>Data processing</topic><topic>Face</topic><topic>Female</topic><topic>France</topic><topic>HIV</topic><topic>HIV Infections - complications</topic><topic>HIV Infections - drug therapy</topic><topic>HIV-Associated Lipodystrophy Syndrome - drug therapy</topic><topic>Hospitals</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Immune system</topic><topic>Immunology</topic><topic>Internal medicine</topic><topic>Lactic Acid - therapeutic use</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Mannitol - therapeutic use</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Physicians</topic><topic>Polyesters</topic><topic>Polymers - therapeutic use</topic><topic>Quality of life</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Duracinsky, Martin</creatorcontrib><creatorcontrib>Leclercq, Pascale</creatorcontrib><creatorcontrib>Herrmann, Susan</creatorcontrib><creatorcontrib>Christen, Marie-Odile</creatorcontrib><creatorcontrib>Dolivo, Marc</creatorcontrib><creatorcontrib>Goujard, Cécile</creatorcontrib><creatorcontrib>Chassany, Olivier</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Duracinsky, Martin</au><au>Leclercq, Pascale</au><au>Herrmann, Susan</au><au>Christen, Marie-Odile</au><au>Dolivo, Marc</au><au>Goujard, Cécile</au><au>Chassany, Olivier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients</atitle><jtitle>BMC infectious diseases</jtitle><addtitle>BMC Infect Dis</addtitle><date>2014-09-01</date><risdate>2014</risdate><volume>14</volume><issue>1</issue><spage>474</spage><epage>474</epage><pages>474-474</pages><artnum>474</artnum><issn>1471-2334</issn><eissn>1471-2334</eissn><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.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>25178390</pmid><doi>10.1186/1471-2334-14-474</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; Springer Nature OA Free Journals; Springer Nature - Complete Springer Journals; PubMed Central |
| subjects | Adult CD4 Lymphocyte Count Cellulose - therapeutic use Clinical outcomes Data processing Face Female France HIV HIV Infections - complications HIV Infections - drug therapy HIV-Associated Lipodystrophy Syndrome - drug therapy Hospitals Human immunodeficiency virus Humans Immune system Immunology Internal medicine Lactic Acid - therapeutic use Longitudinal Studies Male Mannitol - therapeutic use Middle Aged Patients Physicians Polyesters Polymers - therapeutic use Quality of life United States |
| title | Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients |
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