Overall Tolerability of Integrase Inhibitors in Clinical Practice: Results from a Multicenter Italian Cohort
International guidelines recommend the use of integrase strand transfer inhibitor (INI)-based regimens as first-line antiretroviral (ARV) in both naive and experienced HIV-infected patients. We analyzed a multicenter cohort of HIV-infected patients, both naive and experienced, starting an ARV, inclu...
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| Veröffentlicht in: | AIDS research and human retroviruses 2021-01, Vol.37 (1), p.4-10 |
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| creator | Ciccullo, Arturo Baldin, Gianmaria Borghi, Vanni Sterrantino, Gaetana Madeddu, Giordano Latini, Alessandra d'Ettorre, Gabriella Lanari, Alessandro Mazzitelli, Maria Colafigli, Manuela Capetti, Amedeo Ferdinando Oreni, Letizia Lagi, Filippo Rusconi, Stefano Di Giambenedetto, Simona |
| description | International guidelines recommend the use of integrase strand transfer inhibitor (INI)-based regimens as first-line antiretroviral (ARV) in both naive and experienced HIV-infected patients. We analyzed a multicenter cohort of HIV-infected patients, both naive and experienced, starting an ARV, including an INI. Chi-square test and nonparametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meier survival analysis was performed to estimate the probability of maintaining the study drug and Cox-regression analysis to evaluate predictors of discontinuation. We enrolled 4,343 patients: 3,143 (72.4%) were males, with a median age of 49 years (interquartile range 41-55). Naive patients were 733 (16.9%), of whom 168 (22.9%) were AIDS presenters. Overall, 2,282 patients (52.5%) started dolutegravir (DTG), 1,426 (32.8%) raltegravir (RAL), and 635 (14.7%) elvitegravir (EVG). During 10,032 patient years of follow-up (PYFU), we observed 1,278 discontinuations (13 per 100 PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for central nervous system toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% [95% confidence interval (CI): 80.5-82.5] and 76.3% (95% CI: 73.9-78.7), respectively; RAL 61.6% (95% CI: 60.2-63.0) and 54.1% (95% CI: 52.7-55.5); EVG 71.6% (95% CI: 69.2-74.0) and 68.3% (95% CI: 65.3-71.3) (
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| doi_str_mv | 10.1089/aid.2020.0078 |
| format | Article |
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< .001). At a multivariable analysis, being on a RAL-based ARV [vs. DTG, adjusted hazard ratio (aHR) 2.9, 95% CI: 2.3-3.6,
< .001], a EVG-based ARV (vs. DTG, aHR 1.3 95% CI: 1.1-1.7,
= .049), and a peak HIV-RNA >500k cp/mL (aHR 1.3, 95% CI: 1.1-1.6,
= .006) predicted INI discontinuation. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.</description><identifier>ISSN: 0889-2229</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/aid.2020.0078</identifier><identifier>PMID: 32998526</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Antiretroviral agents ; Central nervous system ; Chi-square test ; Clinical medicine ; Confidence intervals ; Continuity (mathematics) ; HIV ; Human immunodeficiency virus ; Integrase ; Regression analysis ; Ribonucleic acid ; RNA ; Statistical analysis ; Statistical tests ; Survival analysis ; Toxicity</subject><ispartof>AIDS research and human retroviruses, 2021-01, Vol.37 (1), p.4-10</ispartof><rights>Copyright Mary Ann Liebert, Inc. Jan 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c360t-876fc965f08cb4628b2c424ffd4a82943476bb6d0cbc2558d88be30a510c6d2f3</citedby><cites>FETCH-LOGICAL-c360t-876fc965f08cb4628b2c424ffd4a82943476bb6d0cbc2558d88be30a510c6d2f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32998526$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ciccullo, Arturo</creatorcontrib><creatorcontrib>Baldin, Gianmaria</creatorcontrib><creatorcontrib>Borghi, Vanni</creatorcontrib><creatorcontrib>Sterrantino, Gaetana</creatorcontrib><creatorcontrib>Madeddu, Giordano</creatorcontrib><creatorcontrib>Latini, Alessandra</creatorcontrib><creatorcontrib>d'Ettorre, Gabriella</creatorcontrib><creatorcontrib>Lanari, Alessandro</creatorcontrib><creatorcontrib>Mazzitelli, Maria</creatorcontrib><creatorcontrib>Colafigli, Manuela</creatorcontrib><creatorcontrib>Capetti, Amedeo Ferdinando</creatorcontrib><creatorcontrib>Oreni, Letizia</creatorcontrib><creatorcontrib>Lagi, Filippo</creatorcontrib><creatorcontrib>Rusconi, Stefano</creatorcontrib><creatorcontrib>Di Giambenedetto, Simona</creatorcontrib><title>Overall Tolerability of Integrase Inhibitors in Clinical Practice: Results from a Multicenter Italian Cohort</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>International guidelines recommend the use of integrase strand transfer inhibitor (INI)-based regimens as first-line antiretroviral (ARV) in both naive and experienced HIV-infected patients. We analyzed a multicenter cohort of HIV-infected patients, both naive and experienced, starting an ARV, including an INI. Chi-square test and nonparametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meier survival analysis was performed to estimate the probability of maintaining the study drug and Cox-regression analysis to evaluate predictors of discontinuation. We enrolled 4,343 patients: 3,143 (72.4%) were males, with a median age of 49 years (interquartile range 41-55). Naive patients were 733 (16.9%), of whom 168 (22.9%) were AIDS presenters. Overall, 2,282 patients (52.5%) started dolutegravir (DTG), 1,426 (32.8%) raltegravir (RAL), and 635 (14.7%) elvitegravir (EVG). During 10,032 patient years of follow-up (PYFU), we observed 1,278 discontinuations (13 per 100 PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for central nervous system toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% [95% confidence interval (CI): 80.5-82.5] and 76.3% (95% CI: 73.9-78.7), respectively; RAL 61.6% (95% CI: 60.2-63.0) and 54.1% (95% CI: 52.7-55.5); EVG 71.6% (95% CI: 69.2-74.0) and 68.3% (95% CI: 65.3-71.3) (
< .001). At a multivariable analysis, being on a RAL-based ARV [vs. DTG, adjusted hazard ratio (aHR) 2.9, 95% CI: 2.3-3.6,
< .001], a EVG-based ARV (vs. DTG, aHR 1.3 95% CI: 1.1-1.7,
= .049), and a peak HIV-RNA >500k cp/mL (aHR 1.3, 95% CI: 1.1-1.6,
= .006) predicted INI discontinuation. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.</description><subject>Antiretroviral agents</subject><subject>Central nervous system</subject><subject>Chi-square test</subject><subject>Clinical medicine</subject><subject>Confidence intervals</subject><subject>Continuity (mathematics)</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Integrase</subject><subject>Regression analysis</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Statistical analysis</subject><subject>Statistical tests</subject><subject>Survival analysis</subject><subject>Toxicity</subject><issn>0889-2229</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNo9kEtLBDEQhIMouj6OXiXgedaenkk28SaLjwVFET0PSSbRSHajSVbw35vFx6mrm6pq-Ag5bmHagpBnyo9TBIQpwExskUkru7YRPbBtMgEhZIOIco_s5_wGABKR7ZK9DqUUDPmEhPtPm1QI9CmGKrQPvnzR6OhiVexLUtlW9eq1LzFl6ld0HvzKGxXoQ1KmeGPP6aPN61AydSkuqaJ3dan3mk90UVTwqqbia0zlkOw4FbI9-p0H5Pnq8ml-09zeXy_mF7eN6TiURsy4M5IzB8LonqPQaHrsnRt7JVD2XT_jWvMRjDbImBiF0LYDxVowfETXHZDTn973FD_WNpfhLa7Tqr4csJ8xhoIjVlfz4zIp5pysG96TX6r0NbQwbNgOle2wYTts2Fb_yW_rWi_t-O_-g9l9A-BidWs</recordid><startdate>202101</startdate><enddate>202101</enddate><creator>Ciccullo, Arturo</creator><creator>Baldin, Gianmaria</creator><creator>Borghi, Vanni</creator><creator>Sterrantino, Gaetana</creator><creator>Madeddu, Giordano</creator><creator>Latini, Alessandra</creator><creator>d'Ettorre, Gabriella</creator><creator>Lanari, Alessandro</creator><creator>Mazzitelli, Maria</creator><creator>Colafigli, Manuela</creator><creator>Capetti, Amedeo Ferdinando</creator><creator>Oreni, Letizia</creator><creator>Lagi, Filippo</creator><creator>Rusconi, Stefano</creator><creator>Di Giambenedetto, Simona</creator><general>Mary Ann Liebert, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T5</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>M7N</scope><scope>P64</scope></search><sort><creationdate>202101</creationdate><title>Overall Tolerability of Integrase Inhibitors in Clinical Practice: Results from a Multicenter Italian Cohort</title><author>Ciccullo, Arturo ; 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We analyzed a multicenter cohort of HIV-infected patients, both naive and experienced, starting an ARV, including an INI. Chi-square test and nonparametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meier survival analysis was performed to estimate the probability of maintaining the study drug and Cox-regression analysis to evaluate predictors of discontinuation. We enrolled 4,343 patients: 3,143 (72.4%) were males, with a median age of 49 years (interquartile range 41-55). Naive patients were 733 (16.9%), of whom 168 (22.9%) were AIDS presenters. Overall, 2,282 patients (52.5%) started dolutegravir (DTG), 1,426 (32.8%) raltegravir (RAL), and 635 (14.7%) elvitegravir (EVG). During 10,032 patient years of follow-up (PYFU), we observed 1,278 discontinuations (13 per 100 PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for central nervous system toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% [95% confidence interval (CI): 80.5-82.5] and 76.3% (95% CI: 73.9-78.7), respectively; RAL 61.6% (95% CI: 60.2-63.0) and 54.1% (95% CI: 52.7-55.5); EVG 71.6% (95% CI: 69.2-74.0) and 68.3% (95% CI: 65.3-71.3) (
< .001). At a multivariable analysis, being on a RAL-based ARV [vs. DTG, adjusted hazard ratio (aHR) 2.9, 95% CI: 2.3-3.6,
< .001], a EVG-based ARV (vs. DTG, aHR 1.3 95% CI: 1.1-1.7,
= .049), and a peak HIV-RNA >500k cp/mL (aHR 1.3, 95% CI: 1.1-1.6,
= .006) predicted INI discontinuation. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>32998526</pmid><doi>10.1089/aid.2020.0078</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | AIDS research and human retroviruses, 2021-01, Vol.37 (1), p.4-10 |
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| language | eng |
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| source | Alma/SFX Local Collection |
| subjects | Antiretroviral agents Central nervous system Chi-square test Clinical medicine Confidence intervals Continuity (mathematics) HIV Human immunodeficiency virus Integrase Regression analysis Ribonucleic acid RNA Statistical analysis Statistical tests Survival analysis Toxicity |
| title | Overall Tolerability of Integrase Inhibitors in Clinical Practice: Results from a Multicenter Italian Cohort |
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