Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial

Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated wi...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Infectious diseases and therapy 2024-11
Hauptverfasser: Rossetti, Barbara, Ferrara, Micol, Taramasso, Lucia, Bai, Francesca, Lombardi, Francesca, Ciccarelli, Nicoletta, Durante, Miriam, Alladio, Francesca, Bonazza, Federica, Rancan, Ilaria, Montagnani, Francesca, Di Biagio, Antonio, Monforte, Antonella d'Arminio, Zazzi, Maurizio, Fabbiani, Massimiliano
Format: Artikel
Sprache:eng
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page
container_issue
container_start_page
container_title Infectious diseases and therapy
container_volume
creator Rossetti, Barbara
Ferrara, Micol
Taramasso, Lucia
Bai, Francesca
Lombardi, Francesca
Ciccarelli, Nicoletta
Durante, Miriam
Alladio, Francesca
Bonazza, Federica
Rancan, Ilaria
Montagnani, Francesca
Di Biagio, Antonio
Monforte, Antonella d'Arminio
Zazzi, Maurizio
Fabbiani, Massimiliano
description Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for > 6 months and with HIV-RNA  12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus. A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom. Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.
doi_str_mv 10.1007/s40121-024-01083-1
format Article
fullrecord <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_3134069514</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3134069514</sourcerecordid><originalsourceid>FETCH-LOGICAL-p921-4d3384aa5a611e2cc0d85dcfbb55b5a5a599961d1285b2f0ca929013c014443a3</originalsourceid><addsrcrecordid>eNo9UE1PGzEQ9YEKIuAPcEA-9rKNvbaTdW8JpC1SVCSSe-S1x-Bqvd7a3qD0J_KrMAR6mtG8j3l6CF1R8o0SMp8mTmhNK1LzilDSsIqeoElNJauaupZn6DKlP4QUTsOpnJ-iMyZnRSDkBL2s9qEbsws9DhZvoLNVhCHEDAb_hjGGIR30k1M5Oo03Bz_k4BNe2AwRb55dLlj_iG0MHt--GcFjVHsXp4tW6fdlrbzbj8b1gHPAS6f_U1b-zdRl1RZwuoU-2FDueNEpC32RGfiOHyCNXU7HD_kJ8IPqTfDuX8l3e7-8e8-It9Gp7gJ9sapLcPkxz9H2x2p786ta3_-8u1msq0GWkrhhrOFKCTWjFGqtiWmE0bZthWhFOQspSzumlCXa2hKtZC0JZZpQzjlT7Bx9PdoOMfwdIeWdd0lD16kewph2jDJOZlJQXqjXH9Sx9WB2Q3RexcPus372CghKi6w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3134069514</pqid></control><display><type>article</type><title>Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial</title><source>DOAJ Directory of Open Access Journals</source><source>Springer Nature OA Free Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Rossetti, Barbara ; Ferrara, Micol ; Taramasso, Lucia ; Bai, Francesca ; Lombardi, Francesca ; Ciccarelli, Nicoletta ; Durante, Miriam ; Alladio, Francesca ; Bonazza, Federica ; Rancan, Ilaria ; Montagnani, Francesca ; Di Biagio, Antonio ; Monforte, Antonella d'Arminio ; Zazzi, Maurizio ; Fabbiani, Massimiliano</creator><creatorcontrib>Rossetti, Barbara ; Ferrara, Micol ; Taramasso, Lucia ; Bai, Francesca ; Lombardi, Francesca ; Ciccarelli, Nicoletta ; Durante, Miriam ; Alladio, Francesca ; Bonazza, Federica ; Rancan, Ilaria ; Montagnani, Francesca ; Di Biagio, Antonio ; Monforte, Antonella d'Arminio ; Zazzi, Maurizio ; Fabbiani, Massimiliano ; for DOBINeuro study group</creatorcontrib><description>Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for &gt; 6 months and with HIV-RNA &lt; 50 cps/ml for &gt; 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus. A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom. Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.</description><identifier>ISSN: 2193-8229</identifier><identifier>DOI: 10.1007/s40121-024-01083-1</identifier><identifier>PMID: 39612159</identifier><language>eng</language><publisher>New Zealand</publisher><ispartof>Infectious diseases and therapy, 2024-11</ispartof><rights>2024. The Author(s).</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0003-1659-9241</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,864,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39612159$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rossetti, Barbara</creatorcontrib><creatorcontrib>Ferrara, Micol</creatorcontrib><creatorcontrib>Taramasso, Lucia</creatorcontrib><creatorcontrib>Bai, Francesca</creatorcontrib><creatorcontrib>Lombardi, Francesca</creatorcontrib><creatorcontrib>Ciccarelli, Nicoletta</creatorcontrib><creatorcontrib>Durante, Miriam</creatorcontrib><creatorcontrib>Alladio, Francesca</creatorcontrib><creatorcontrib>Bonazza, Federica</creatorcontrib><creatorcontrib>Rancan, Ilaria</creatorcontrib><creatorcontrib>Montagnani, Francesca</creatorcontrib><creatorcontrib>Di Biagio, Antonio</creatorcontrib><creatorcontrib>Monforte, Antonella d'Arminio</creatorcontrib><creatorcontrib>Zazzi, Maurizio</creatorcontrib><creatorcontrib>Fabbiani, Massimiliano</creatorcontrib><creatorcontrib>for DOBINeuro study group</creatorcontrib><title>Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial</title><title>Infectious diseases and therapy</title><addtitle>Infect Dis Ther</addtitle><description>Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for &gt; 6 months and with HIV-RNA &lt; 50 cps/ml for &gt; 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus. A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom. Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.</description><issn>2193-8229</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNo9UE1PGzEQ9YEKIuAPcEA-9rKNvbaTdW8JpC1SVCSSe-S1x-Bqvd7a3qD0J_KrMAR6mtG8j3l6CF1R8o0SMp8mTmhNK1LzilDSsIqeoElNJauaupZn6DKlP4QUTsOpnJ-iMyZnRSDkBL2s9qEbsws9DhZvoLNVhCHEDAb_hjGGIR30k1M5Oo03Bz_k4BNe2AwRb55dLlj_iG0MHt--GcFjVHsXp4tW6fdlrbzbj8b1gHPAS6f_U1b-zdRl1RZwuoU-2FDueNEpC32RGfiOHyCNXU7HD_kJ8IPqTfDuX8l3e7-8e8-It9Gp7gJ9sapLcPkxz9H2x2p786ta3_-8u1msq0GWkrhhrOFKCTWjFGqtiWmE0bZthWhFOQspSzumlCXa2hKtZC0JZZpQzjlT7Bx9PdoOMfwdIeWdd0lD16kewph2jDJOZlJQXqjXH9Sx9WB2Q3RexcPus372CghKi6w</recordid><startdate>20241129</startdate><enddate>20241129</enddate><creator>Rossetti, Barbara</creator><creator>Ferrara, Micol</creator><creator>Taramasso, Lucia</creator><creator>Bai, Francesca</creator><creator>Lombardi, Francesca</creator><creator>Ciccarelli, Nicoletta</creator><creator>Durante, Miriam</creator><creator>Alladio, Francesca</creator><creator>Bonazza, Federica</creator><creator>Rancan, Ilaria</creator><creator>Montagnani, Francesca</creator><creator>Di Biagio, Antonio</creator><creator>Monforte, Antonella d'Arminio</creator><creator>Zazzi, Maurizio</creator><creator>Fabbiani, Massimiliano</creator><scope>NPM</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1659-9241</orcidid></search><sort><creationdate>20241129</creationdate><title>Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial</title><author>Rossetti, Barbara ; Ferrara, Micol ; Taramasso, Lucia ; Bai, Francesca ; Lombardi, Francesca ; Ciccarelli, Nicoletta ; Durante, Miriam ; Alladio, Francesca ; Bonazza, Federica ; Rancan, Ilaria ; Montagnani, Francesca ; Di Biagio, Antonio ; Monforte, Antonella d'Arminio ; Zazzi, Maurizio ; Fabbiani, Massimiliano</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p921-4d3384aa5a611e2cc0d85dcfbb55b5a5a599961d1285b2f0ca929013c014443a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rossetti, Barbara</creatorcontrib><creatorcontrib>Ferrara, Micol</creatorcontrib><creatorcontrib>Taramasso, Lucia</creatorcontrib><creatorcontrib>Bai, Francesca</creatorcontrib><creatorcontrib>Lombardi, Francesca</creatorcontrib><creatorcontrib>Ciccarelli, Nicoletta</creatorcontrib><creatorcontrib>Durante, Miriam</creatorcontrib><creatorcontrib>Alladio, Francesca</creatorcontrib><creatorcontrib>Bonazza, Federica</creatorcontrib><creatorcontrib>Rancan, Ilaria</creatorcontrib><creatorcontrib>Montagnani, Francesca</creatorcontrib><creatorcontrib>Di Biagio, Antonio</creatorcontrib><creatorcontrib>Monforte, Antonella d'Arminio</creatorcontrib><creatorcontrib>Zazzi, Maurizio</creatorcontrib><creatorcontrib>Fabbiani, Massimiliano</creatorcontrib><creatorcontrib>for DOBINeuro study group</creatorcontrib><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Infectious diseases and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rossetti, Barbara</au><au>Ferrara, Micol</au><au>Taramasso, Lucia</au><au>Bai, Francesca</au><au>Lombardi, Francesca</au><au>Ciccarelli, Nicoletta</au><au>Durante, Miriam</au><au>Alladio, Francesca</au><au>Bonazza, Federica</au><au>Rancan, Ilaria</au><au>Montagnani, Francesca</au><au>Di Biagio, Antonio</au><au>Monforte, Antonella d'Arminio</au><au>Zazzi, Maurizio</au><au>Fabbiani, Massimiliano</au><aucorp>for DOBINeuro study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial</atitle><jtitle>Infectious diseases and therapy</jtitle><addtitle>Infect Dis Ther</addtitle><date>2024-11-29</date><risdate>2024</risdate><issn>2193-8229</issn><abstract>Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for &gt; 6 months and with HIV-RNA &lt; 50 cps/ml for &gt; 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus. A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom. Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.</abstract><cop>New Zealand</cop><pmid>39612159</pmid><doi>10.1007/s40121-024-01083-1</doi><orcidid>https://orcid.org/0000-0003-1659-9241</orcidid></addata></record>
fulltext fulltext
identifier ISSN: 2193-8229
ispartof Infectious diseases and therapy, 2024-11
issn 2193-8229
language eng
recordid cdi_proquest_miscellaneous_3134069514
source DOAJ Directory of Open Access Journals; Springer Nature OA Free Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central
title Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T13%3A54%3A10IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Evolution%20of%20Self-reported%20Neuropsychiatric%20Symptoms%20After%20Switching%20from%20Dolutegravir/Abacavir/Lamivudine%20to%20Bictegravir/Emtricitabine/Tenofovir%20Alafenamide:%20Results%20from%20the%20Randomized%20DOBINeuro%20Trial&rft.jtitle=Infectious%20diseases%20and%20therapy&rft.au=Rossetti,%20Barbara&rft.aucorp=for%20DOBINeuro%20study%20group&rft.date=2024-11-29&rft.issn=2193-8229&rft_id=info:doi/10.1007/s40121-024-01083-1&rft_dat=%3Cproquest_pubme%3E3134069514%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3134069514&rft_id=info:pmid/39612159&rfr_iscdi=true