Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort
Objectives The aim of the present study was to compare the efficacy and durability of treatment switch to two‐drug (2DR) vs. three‐drug (3DR) integrase inhibitor (InSTI)‐based regimens in a real‐life setting. Methods Within the ODOACRE cohort, we selected adult patients with HIV RNA 1000 copies/mL...
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| Veröffentlicht in: | HIV medicine 2021-10, Vol.22 (9), p.843-853 |
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| creator | Fabbiani, Massimiliano Rossetti, Barbara Ciccullo, Arturo Oreni, Letizia Lagi, Filippo Celani, Luigi Colafigli, Manuela De Vito, Andrea Mazzitelli, Maria Dusina, Alex Durante, Miriam Montagnani, Francesca Rusconi, Stefano Capetti, Amedeo Sterrantino, Gaetana D’Ettorre, Gabriella Di Giambenedetto, Simona Zanelli, Giacomo Baldin, Gianmaria Borghetti, Alberto Latini, Alessandra Mastroianni, Claudio Borghi, Vanni Mussini, Cristina Cossu, Maria Vittoria Giacomelli, Andrea Formenti, Tiziana Trecarichi, Enrico Maria Torti, Carlo Madeddu, Giordano Vecchiet, Jacopo Vignale, Francesca Giacometti, Andrea |
| description | Objectives
The aim of the present study was to compare the efficacy and durability of treatment switch to two‐drug (2DR) vs. three‐drug (3DR) integrase inhibitor (InSTI)‐based regimens in a real‐life setting.
Methods
Within the ODOACRE cohort, we selected adult patients with HIV RNA 1000 copies/mL or two consecutive HIV RNA > 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors.
Results
Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir‐, raltegravir‐ and dolutegravir‐based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine).
Over a median (interquartile range) follow‐up of 100 (52–150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person‐year of follow‐up (PYFU). The estimated 96‐week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04).
Four hundred (24%) patients discontinued their InSTI‐based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P |
| doi_str_mv | 10.1111/hiv.13146 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2555968132</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2572370850</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3536-7f616c53e3a43e4e24eab7473816d02f47301d24b4897ecf7df63ce2bfd1261a3</originalsourceid><addsrcrecordid>eNp1kc1u1DAUhSNERf9Y8ALIEpt2kWlsJ07CrpoObaVKI6HCNnKc6xlXThxsZ6rseARehVfiSbjtFBZIeGGf6_vdI8snSd7RbEFxXWzNbkE5zcWr5Aj3KqWs5q-fdZ4yIdhhchzCQ5bRktfZm-SQ55xWRU2Pkp8rrY2SaiZy6Eg3edkaa-JMnCbx0f36_oPswoLErQfAovPThpghwsbLAKi2pjXReWy1eNERDxvTwxCwRXbGO-s2aG_tTMI0jh7CE3Rz-xUHzKBBRSxHGQ0MMXwkVzJKor3r0UdaZKzRQNZX68vl5xVRbut8PE0OtLQB3r6cJ8mXT6v75U16t76-XV7epYoXXKSlFlSoggOXOYccWA6yLfOSV1R0GdOoMtqxvM2rugSly04LroC1uqNMUMlPkrO97-jdtwlCbHoTFFgrB3BTaFhRFLWoKGeIfvgHfXCTH_B1SJWMl1lVZEid7ynlXQgedDN600s_NzRrnnJsMMfmOUdk3784Tm0P3V_yT3AIXOyBR2Nh_r9Tg3-9t_wNp3quCA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2572370850</pqid></control><display><type>article</type><title>Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort</title><source>Wiley Free Content</source><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Fabbiani, Massimiliano ; Rossetti, Barbara ; Ciccullo, Arturo ; Oreni, Letizia ; Lagi, Filippo ; Celani, Luigi ; Colafigli, Manuela ; De Vito, Andrea ; Mazzitelli, Maria ; Dusina, Alex ; Durante, Miriam ; Montagnani, Francesca ; Rusconi, Stefano ; Capetti, Amedeo ; Sterrantino, Gaetana ; D’Ettorre, Gabriella ; Di Giambenedetto, Simona ; Zanelli, Giacomo ; Baldin, Gianmaria ; Borghetti, Alberto ; Latini, Alessandra ; Mastroianni, Claudio ; Borghi, Vanni ; Mussini, Cristina ; Cossu, Maria Vittoria ; Giacomelli, Andrea ; Formenti, Tiziana ; Trecarichi, Enrico Maria ; Torti, Carlo ; Madeddu, Giordano ; Vecchiet, Jacopo ; Vignale, Francesca ; Giacometti, Andrea</creator><creatorcontrib>Fabbiani, Massimiliano ; Rossetti, Barbara ; Ciccullo, Arturo ; Oreni, Letizia ; Lagi, Filippo ; Celani, Luigi ; Colafigli, Manuela ; De Vito, Andrea ; Mazzitelli, Maria ; Dusina, Alex ; Durante, Miriam ; Montagnani, Francesca ; Rusconi, Stefano ; Capetti, Amedeo ; Sterrantino, Gaetana ; D’Ettorre, Gabriella ; Di Giambenedetto, Simona ; Zanelli, Giacomo ; Baldin, Gianmaria ; Borghetti, Alberto ; Latini, Alessandra ; Mastroianni, Claudio ; Borghi, Vanni ; Mussini, Cristina ; Cossu, Maria Vittoria ; Giacomelli, Andrea ; Formenti, Tiziana ; Trecarichi, Enrico Maria ; Torti, Carlo ; Madeddu, Giordano ; Vecchiet, Jacopo ; Vignale, Francesca ; Giacometti, Andrea ; ODOACRE Study Group ; for the ODOACRE Study Group</creatorcontrib><description>Objectives
The aim of the present study was to compare the efficacy and durability of treatment switch to two‐drug (2DR) vs. three‐drug (3DR) integrase inhibitor (InSTI)‐based regimens in a real‐life setting.
Methods
Within the ODOACRE cohort, we selected adult patients with HIV RNA < 50 copies/mL switching to an InSTI‐based 2DR or 3DR. Survival analyses were performed to estimate the probability of virological failure (VF, defined as one HIV RNA > 1000 copies/mL or two consecutive HIV RNA > 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors.
Results
Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir‐, raltegravir‐ and dolutegravir‐based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine).
Over a median (interquartile range) follow‐up of 100 (52–150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person‐year of follow‐up (PYFU). The estimated 96‐week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04).
Four hundred (24%) patients discontinued their InSTI‐based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P < 0.001) and TD for toxicity (9.0% vs. 6.6%, P = 0.02) when compared with 2DRs. A higher risk of TD for central nervous system toxicity was observed for dolutegravir than for elvitegravir and raltegravir (4.0% vs. 2.5% vs. 0.6%, P = 0.005).
Conclusions
In virologically suppressed HIV‐infected patients, 2DRs showed an efficacy similar to 3DRs but with better tolerability.</description><identifier>ISSN: 1464-2662</identifier><identifier>EISSN: 1468-1293</identifier><identifier>DOI: 10.1111/hiv.13146</identifier><identifier>PMID: 34318591</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Antiretroviral drugs ; antiretroviral therapy ; Central nervous system ; Cohort Studies ; dual therapy ; Durability ; Failure analysis ; Heterocyclic Compounds, 3-Ring - therapeutic use ; HIV ; HIV Infections - drug therapy ; HIV Integrase Inhibitors - therapeutic use ; Human immunodeficiency virus ; Humans ; Inhibitors ; InSTI ; Integrase ; Lamivudine ; Lamivudine - therapeutic use ; Oxazines - therapeutic use ; Patients ; Raltegravir Potassium - therapeutic use ; Ribonucleic acid ; RNA ; Toxicity ; treatment discontinuation ; Viral Load ; virological failure</subject><ispartof>HIV medicine, 2021-10, Vol.22 (9), p.843-853</ispartof><rights>2021 British HIV Association</rights><rights>2021 British HIV Association.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3536-7f616c53e3a43e4e24eab7473816d02f47301d24b4897ecf7df63ce2bfd1261a3</citedby><cites>FETCH-LOGICAL-c3536-7f616c53e3a43e4e24eab7473816d02f47301d24b4897ecf7df63ce2bfd1261a3</cites><orcidid>0000-0002-8265-5400 ; 0000-0002-0375-9990 ; 0000-0002-1343-812X ; 0000-0001-5941-883X ; 0000-0003-0263-0703 ; 0000-0003-1659-9241 ; 0000-0002-0385-0903</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhiv.13146$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhiv.13146$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34318591$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fabbiani, Massimiliano</creatorcontrib><creatorcontrib>Rossetti, Barbara</creatorcontrib><creatorcontrib>Ciccullo, Arturo</creatorcontrib><creatorcontrib>Oreni, Letizia</creatorcontrib><creatorcontrib>Lagi, Filippo</creatorcontrib><creatorcontrib>Celani, Luigi</creatorcontrib><creatorcontrib>Colafigli, Manuela</creatorcontrib><creatorcontrib>De Vito, Andrea</creatorcontrib><creatorcontrib>Mazzitelli, Maria</creatorcontrib><creatorcontrib>Dusina, Alex</creatorcontrib><creatorcontrib>Durante, Miriam</creatorcontrib><creatorcontrib>Montagnani, Francesca</creatorcontrib><creatorcontrib>Rusconi, Stefano</creatorcontrib><creatorcontrib>Capetti, Amedeo</creatorcontrib><creatorcontrib>Sterrantino, Gaetana</creatorcontrib><creatorcontrib>D’Ettorre, Gabriella</creatorcontrib><creatorcontrib>Di Giambenedetto, Simona</creatorcontrib><creatorcontrib>Zanelli, Giacomo</creatorcontrib><creatorcontrib>Baldin, Gianmaria</creatorcontrib><creatorcontrib>Borghetti, Alberto</creatorcontrib><creatorcontrib>Latini, Alessandra</creatorcontrib><creatorcontrib>Mastroianni, Claudio</creatorcontrib><creatorcontrib>Borghi, Vanni</creatorcontrib><creatorcontrib>Mussini, Cristina</creatorcontrib><creatorcontrib>Cossu, Maria Vittoria</creatorcontrib><creatorcontrib>Giacomelli, Andrea</creatorcontrib><creatorcontrib>Formenti, Tiziana</creatorcontrib><creatorcontrib>Trecarichi, Enrico Maria</creatorcontrib><creatorcontrib>Torti, Carlo</creatorcontrib><creatorcontrib>Madeddu, Giordano</creatorcontrib><creatorcontrib>Vecchiet, Jacopo</creatorcontrib><creatorcontrib>Vignale, Francesca</creatorcontrib><creatorcontrib>Giacometti, Andrea</creatorcontrib><creatorcontrib>ODOACRE Study Group</creatorcontrib><creatorcontrib>for the ODOACRE Study Group</creatorcontrib><title>Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort</title><title>HIV medicine</title><addtitle>HIV Med</addtitle><description>Objectives
The aim of the present study was to compare the efficacy and durability of treatment switch to two‐drug (2DR) vs. three‐drug (3DR) integrase inhibitor (InSTI)‐based regimens in a real‐life setting.
Methods
Within the ODOACRE cohort, we selected adult patients with HIV RNA < 50 copies/mL switching to an InSTI‐based 2DR or 3DR. Survival analyses were performed to estimate the probability of virological failure (VF, defined as one HIV RNA > 1000 copies/mL or two consecutive HIV RNA > 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors.
Results
Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir‐, raltegravir‐ and dolutegravir‐based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine).
Over a median (interquartile range) follow‐up of 100 (52–150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person‐year of follow‐up (PYFU). The estimated 96‐week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04).
Four hundred (24%) patients discontinued their InSTI‐based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P < 0.001) and TD for toxicity (9.0% vs. 6.6%, P = 0.02) when compared with 2DRs. A higher risk of TD for central nervous system toxicity was observed for dolutegravir than for elvitegravir and raltegravir (4.0% vs. 2.5% vs. 0.6%, P = 0.005).
Conclusions
In virologically suppressed HIV‐infected patients, 2DRs showed an efficacy similar to 3DRs but with better tolerability.</description><subject>Adult</subject><subject>Antiretroviral drugs</subject><subject>antiretroviral therapy</subject><subject>Central nervous system</subject><subject>Cohort Studies</subject><subject>dual therapy</subject><subject>Durability</subject><subject>Failure analysis</subject><subject>Heterocyclic Compounds, 3-Ring - therapeutic use</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Integrase Inhibitors - therapeutic use</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Inhibitors</subject><subject>InSTI</subject><subject>Integrase</subject><subject>Lamivudine</subject><subject>Lamivudine - therapeutic use</subject><subject>Oxazines - therapeutic use</subject><subject>Patients</subject><subject>Raltegravir Potassium - therapeutic use</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Toxicity</subject><subject>treatment discontinuation</subject><subject>Viral Load</subject><subject>virological failure</subject><issn>1464-2662</issn><issn>1468-1293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1u1DAUhSNERf9Y8ALIEpt2kWlsJ07CrpoObaVKI6HCNnKc6xlXThxsZ6rseARehVfiSbjtFBZIeGGf6_vdI8snSd7RbEFxXWzNbkE5zcWr5Aj3KqWs5q-fdZ4yIdhhchzCQ5bRktfZm-SQ55xWRU2Pkp8rrY2SaiZy6Eg3edkaa-JMnCbx0f36_oPswoLErQfAovPThpghwsbLAKi2pjXReWy1eNERDxvTwxCwRXbGO-s2aG_tTMI0jh7CE3Rz-xUHzKBBRSxHGQ0MMXwkVzJKor3r0UdaZKzRQNZX68vl5xVRbut8PE0OtLQB3r6cJ8mXT6v75U16t76-XV7epYoXXKSlFlSoggOXOYccWA6yLfOSV1R0GdOoMtqxvM2rugSly04LroC1uqNMUMlPkrO97-jdtwlCbHoTFFgrB3BTaFhRFLWoKGeIfvgHfXCTH_B1SJWMl1lVZEid7ynlXQgedDN600s_NzRrnnJsMMfmOUdk3784Tm0P3V_yT3AIXOyBR2Nh_r9Tg3-9t_wNp3quCA</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>Fabbiani, Massimiliano</creator><creator>Rossetti, Barbara</creator><creator>Ciccullo, Arturo</creator><creator>Oreni, Letizia</creator><creator>Lagi, Filippo</creator><creator>Celani, Luigi</creator><creator>Colafigli, Manuela</creator><creator>De Vito, Andrea</creator><creator>Mazzitelli, Maria</creator><creator>Dusina, Alex</creator><creator>Durante, Miriam</creator><creator>Montagnani, Francesca</creator><creator>Rusconi, Stefano</creator><creator>Capetti, Amedeo</creator><creator>Sterrantino, Gaetana</creator><creator>D’Ettorre, Gabriella</creator><creator>Di Giambenedetto, Simona</creator><creator>Zanelli, Giacomo</creator><creator>Baldin, Gianmaria</creator><creator>Borghetti, Alberto</creator><creator>Latini, Alessandra</creator><creator>Mastroianni, Claudio</creator><creator>Borghi, Vanni</creator><creator>Mussini, Cristina</creator><creator>Cossu, Maria Vittoria</creator><creator>Giacomelli, Andrea</creator><creator>Formenti, Tiziana</creator><creator>Trecarichi, Enrico Maria</creator><creator>Torti, Carlo</creator><creator>Madeddu, Giordano</creator><creator>Vecchiet, Jacopo</creator><creator>Vignale, Francesca</creator><creator>Giacometti, Andrea</creator><general>Wiley Subscription Services, Inc</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>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-8265-5400</orcidid><orcidid>https://orcid.org/0000-0002-0375-9990</orcidid><orcidid>https://orcid.org/0000-0002-1343-812X</orcidid><orcidid>https://orcid.org/0000-0001-5941-883X</orcidid><orcidid>https://orcid.org/0000-0003-0263-0703</orcidid><orcidid>https://orcid.org/0000-0003-1659-9241</orcidid><orcidid>https://orcid.org/0000-0002-0385-0903</orcidid></search><sort><creationdate>202110</creationdate><title>Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort</title><author>Fabbiani, Massimiliano ; Rossetti, Barbara ; Ciccullo, Arturo ; Oreni, Letizia ; Lagi, Filippo ; Celani, Luigi ; Colafigli, Manuela ; De Vito, Andrea ; Mazzitelli, Maria ; Dusina, Alex ; Durante, Miriam ; Montagnani, Francesca ; Rusconi, Stefano ; Capetti, Amedeo ; Sterrantino, Gaetana ; D’Ettorre, Gabriella ; Di Giambenedetto, Simona ; Zanelli, Giacomo ; Baldin, Gianmaria ; Borghetti, Alberto ; Latini, Alessandra ; Mastroianni, Claudio ; Borghi, Vanni ; Mussini, Cristina ; Cossu, Maria Vittoria ; Giacomelli, Andrea ; Formenti, Tiziana ; Trecarichi, Enrico Maria ; Torti, Carlo ; Madeddu, Giordano ; Vecchiet, Jacopo ; Vignale, Francesca ; Giacometti, Andrea</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3536-7f616c53e3a43e4e24eab7473816d02f47301d24b4897ecf7df63ce2bfd1261a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Antiretroviral drugs</topic><topic>antiretroviral therapy</topic><topic>Central nervous system</topic><topic>Cohort Studies</topic><topic>dual therapy</topic><topic>Durability</topic><topic>Failure analysis</topic><topic>Heterocyclic Compounds, 3-Ring - therapeutic use</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Integrase Inhibitors - therapeutic use</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Inhibitors</topic><topic>InSTI</topic><topic>Integrase</topic><topic>Lamivudine</topic><topic>Lamivudine - therapeutic use</topic><topic>Oxazines - therapeutic use</topic><topic>Patients</topic><topic>Raltegravir Potassium - therapeutic use</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>Toxicity</topic><topic>treatment discontinuation</topic><topic>Viral Load</topic><topic>virological failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fabbiani, Massimiliano</creatorcontrib><creatorcontrib>Rossetti, Barbara</creatorcontrib><creatorcontrib>Ciccullo, Arturo</creatorcontrib><creatorcontrib>Oreni, Letizia</creatorcontrib><creatorcontrib>Lagi, Filippo</creatorcontrib><creatorcontrib>Celani, Luigi</creatorcontrib><creatorcontrib>Colafigli, Manuela</creatorcontrib><creatorcontrib>De Vito, Andrea</creatorcontrib><creatorcontrib>Mazzitelli, Maria</creatorcontrib><creatorcontrib>Dusina, Alex</creatorcontrib><creatorcontrib>Durante, Miriam</creatorcontrib><creatorcontrib>Montagnani, Francesca</creatorcontrib><creatorcontrib>Rusconi, Stefano</creatorcontrib><creatorcontrib>Capetti, Amedeo</creatorcontrib><creatorcontrib>Sterrantino, Gaetana</creatorcontrib><creatorcontrib>D’Ettorre, Gabriella</creatorcontrib><creatorcontrib>Di Giambenedetto, Simona</creatorcontrib><creatorcontrib>Zanelli, Giacomo</creatorcontrib><creatorcontrib>Baldin, Gianmaria</creatorcontrib><creatorcontrib>Borghetti, Alberto</creatorcontrib><creatorcontrib>Latini, Alessandra</creatorcontrib><creatorcontrib>Mastroianni, Claudio</creatorcontrib><creatorcontrib>Borghi, Vanni</creatorcontrib><creatorcontrib>Mussini, Cristina</creatorcontrib><creatorcontrib>Cossu, Maria Vittoria</creatorcontrib><creatorcontrib>Giacomelli, Andrea</creatorcontrib><creatorcontrib>Formenti, Tiziana</creatorcontrib><creatorcontrib>Trecarichi, Enrico Maria</creatorcontrib><creatorcontrib>Torti, Carlo</creatorcontrib><creatorcontrib>Madeddu, Giordano</creatorcontrib><creatorcontrib>Vecchiet, Jacopo</creatorcontrib><creatorcontrib>Vignale, Francesca</creatorcontrib><creatorcontrib>Giacometti, Andrea</creatorcontrib><creatorcontrib>ODOACRE Study Group</creatorcontrib><creatorcontrib>for the ODOACRE Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>HIV medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fabbiani, Massimiliano</au><au>Rossetti, Barbara</au><au>Ciccullo, Arturo</au><au>Oreni, Letizia</au><au>Lagi, Filippo</au><au>Celani, Luigi</au><au>Colafigli, Manuela</au><au>De Vito, Andrea</au><au>Mazzitelli, Maria</au><au>Dusina, Alex</au><au>Durante, Miriam</au><au>Montagnani, Francesca</au><au>Rusconi, Stefano</au><au>Capetti, Amedeo</au><au>Sterrantino, Gaetana</au><au>D’Ettorre, Gabriella</au><au>Di Giambenedetto, Simona</au><au>Zanelli, Giacomo</au><au>Baldin, Gianmaria</au><au>Borghetti, Alberto</au><au>Latini, Alessandra</au><au>Mastroianni, Claudio</au><au>Borghi, Vanni</au><au>Mussini, Cristina</au><au>Cossu, Maria Vittoria</au><au>Giacomelli, Andrea</au><au>Formenti, Tiziana</au><au>Trecarichi, Enrico Maria</au><au>Torti, Carlo</au><au>Madeddu, Giordano</au><au>Vecchiet, Jacopo</au><au>Vignale, Francesca</au><au>Giacometti, Andrea</au><aucorp>ODOACRE Study Group</aucorp><aucorp>for the ODOACRE Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort</atitle><jtitle>HIV medicine</jtitle><addtitle>HIV Med</addtitle><date>2021-10</date><risdate>2021</risdate><volume>22</volume><issue>9</issue><spage>843</spage><epage>853</epage><pages>843-853</pages><issn>1464-2662</issn><eissn>1468-1293</eissn><abstract>Objectives
The aim of the present study was to compare the efficacy and durability of treatment switch to two‐drug (2DR) vs. three‐drug (3DR) integrase inhibitor (InSTI)‐based regimens in a real‐life setting.
Methods
Within the ODOACRE cohort, we selected adult patients with HIV RNA < 50 copies/mL switching to an InSTI‐based 2DR or 3DR. Survival analyses were performed to estimate the probability of virological failure (VF, defined as one HIV RNA > 1000 copies/mL or two consecutive HIV RNA > 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors.
Results
Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir‐, raltegravir‐ and dolutegravir‐based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine).
Over a median (interquartile range) follow‐up of 100 (52–150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person‐year of follow‐up (PYFU). The estimated 96‐week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04).
Four hundred (24%) patients discontinued their InSTI‐based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P < 0.001) and TD for toxicity (9.0% vs. 6.6%, P = 0.02) when compared with 2DRs. A higher risk of TD for central nervous system toxicity was observed for dolutegravir than for elvitegravir and raltegravir (4.0% vs. 2.5% vs. 0.6%, P = 0.005).
Conclusions
In virologically suppressed HIV‐infected patients, 2DRs showed an efficacy similar to 3DRs but with better tolerability.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>34318591</pmid><doi>10.1111/hiv.13146</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-8265-5400</orcidid><orcidid>https://orcid.org/0000-0002-0375-9990</orcidid><orcidid>https://orcid.org/0000-0002-1343-812X</orcidid><orcidid>https://orcid.org/0000-0001-5941-883X</orcidid><orcidid>https://orcid.org/0000-0003-0263-0703</orcidid><orcidid>https://orcid.org/0000-0003-1659-9241</orcidid><orcidid>https://orcid.org/0000-0002-0385-0903</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1464-2662 |
| ispartof | HIV medicine, 2021-10, Vol.22 (9), p.843-853 |
| issn | 1464-2662 1468-1293 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2555968132 |
| source | Wiley Free Content; MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adult Antiretroviral drugs antiretroviral therapy Central nervous system Cohort Studies dual therapy Durability Failure analysis Heterocyclic Compounds, 3-Ring - therapeutic use HIV HIV Infections - drug therapy HIV Integrase Inhibitors - therapeutic use Human immunodeficiency virus Humans Inhibitors InSTI Integrase Lamivudine Lamivudine - therapeutic use Oxazines - therapeutic use Patients Raltegravir Potassium - therapeutic use Ribonucleic acid RNA Toxicity treatment discontinuation Viral Load virological failure |
| title | Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T11%3A28%3A30IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20durability%20of%20two%E2%80%90%20vs.%20three%E2%80%90drug%20integrase%20inhibitor%E2%80%90based%20regimens%20in%20virologically%20suppressed%20HIV%E2%80%90infected%20patients:%20Data%20from%20real%E2%80%90life%20ODOACRE%20cohort&rft.jtitle=HIV%20medicine&rft.au=Fabbiani,%20Massimiliano&rft.aucorp=ODOACRE%20Study%20Group&rft.date=2021-10&rft.volume=22&rft.issue=9&rft.spage=843&rft.epage=853&rft.pages=843-853&rft.issn=1464-2662&rft.eissn=1468-1293&rft_id=info:doi/10.1111/hiv.13146&rft_dat=%3Cproquest_cross%3E2572370850%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2572370850&rft_id=info:pmid/34318591&rfr_iscdi=true |