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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EPatients with invasive fungal disease and comorbid conditions such as hematologic malignancy and uncontrolled malignancy were successfully treated with the novel triazole antifungal agent isavuconazole, regardless of minimum inhibitory concentrations required by baseline Aspergillus spp isolates. This article presents data according to type of malignancy from the Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis trial [SECURE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00412893\u0026amp;atom=%2Fspmdc%2F14%2F28%2F14.atom\u0022\u003ENCT00412893\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EFungal Infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EFungal Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EPatients with invasive fungal disease (IFD) and comorbid conditions such as hematologic malignancy (HM) and uncontrolled malignancy (UncCA) were successfully treated with the novel triazole antifungal agent isavuconazole, regardless of minimum inhibitory concentrations (MICa) required by baseline \u003Cem\u003EAspergillus\u003C\/em\u003E spp isolates. Andrew J. Ullmann, MD, Julius Maximilians University, W\u00fcrzburg, Germany, presented data according to type of malignancy from the Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis trial [SECURE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00412893\u0026amp;atom=%2Fspmdc%2F14%2F28%2F14.atom\u0022\u003ENCT00412893\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EIFD is a challenge, particularly in immunocompromised patients [Leventakos K et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2010; Kontoyiannis DP et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2010; Pappas PG et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2010], and patients with UncCA [Bohme A et al. \u003Cem\u003EAnn Hematol\u003C\/em\u003E 2009] and HM [Pagano L et al. \u003Cem\u003EHaematologica\u003C\/em\u003E 2006]. In addition, mortality rates remain high in populations such as organ or hematopoietic stem cell transplant recipients who have invasive aspergillosis (IA) [Baddley JW et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2010]. The broad-spectrum triazole antifungal agent, isavuconazole, demonstrated efficacy against multiple pathogens, including \u003Cem\u003EAspergillus\u003C\/em\u003E spp, \u003Cem\u003ECandida\u003C\/em\u003E spp, \u003Cem\u003ECryptococcus\u003C\/em\u003E spp, and Mucorales in vitro, as well as IA, invasive candidiasis, mucormycosis, and cryptococcosis in animal models [Lepak A et al. \u003Cem\u003EAntimicrob Agents Chemother\u003C\/em\u003E 2013; Lepak A et al. \u003Cem\u003EAntimicrob Agents Chemother\u003C\/em\u003E 2013; Luo G et al. \u003Cem\u003EAntimicrob Agents Chemother\u003C\/em\u003E 2014]. The overarching purpose of the SECURE trial was to evaluate the safety and efficacy of isavuconazole in patients with IFD [Maertens J et al. ECCMID 2014 0230a]; the purpose of this analysis was to evaluate the outcomes of isavuconazole treatment in patients with UncCA who participated in the SECURE trial.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the multicenter, noninferiority, Phase 3 SECURE trial, 516 patients (intention-to-treat population) age \u2265 18 years with proven or probable IFD were randomly assigned to receive 200 mg IV TID isavuconazole for 2 days followed by 200 mg (IV or oral) QD or standard-dose voriconazole. The primary end point of all-cause mortality at day 42 was 22% and 25% in the isavuconazole and voriconazole arms, respectively, with drug-related adverse events occurring more frequently in the voriconazole arm (60 vs 40%). Secondary end points included success rate, adverse events, and other safety parameters.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn the SECURE trial, 178 patients had UncCA, and they were evenly split between the isavuconazole and voriconazole arms. In patients with UncCA, the all-cause mortality at day 42 was 21% and 22% in patients who received isavuconazole compared with voriconazole, respectively, with a mean difference of \u22120.5 (95% CI, \u22129.6 to 8.6). The overall response at the end of the trial (EOT) was 36% and 34% in the isavuconazole and voriconazole arms, respectively, with a mean difference of \u22122.2 (95% CI, \u221217.4 to 13.0). Patients without UncCA demonstrated lower rates of all-cause mortality at day 42 in the intention-to-treat population; however, patients with UncCa taking isavuconazole demonstrated lower rates of all-cause mortality compared with the voriconazole arm. EOT overall response was greatest in patients infected with mold species not otherwise specified and \u003Cem\u003EAspergillus\u003C\/em\u003E spp only compared with non-\u003Cem\u003EAspergillus\u003C\/em\u003E spp only or positive serum for galactomannan.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ETreatment-emergent adverse events (TEAEs) were similar among both treatment arms in patients with UncCA; however, fewer patients in the isavuconazole arm (40%) experienced drug-related adverse events compared with those treated with voriconazole (60%).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIn conclusion, Prof Ullmann indicated that patients with UncCA demonstrated greater mortality rates in both treatment arms compared with patients without UncCA; however, patients treated with isavuconazole experienced fewer drug-related adverse events.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EKieren A. Marr, MD, Johns Hopkins University, Baltimore, Maryland, USA, presented an analysis of patients with HM from the SECURE trial. Out of the 516 patients in the intention-to-treat population, 433 had HM, of which 217 had proven or probable IFD.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EIn patients with HM, all-cause mortality at day 42 was 22% and 24% in the isavuconazole and voriconazole arms, respectively, with a mean difference of \u22121.5 (95% CI, \u221213.7 to 10.7). All-cause mortality was lowest in patients with acute myeloid leukemia compared with those with UncCA, acute lymphocytic leukemia, neutropenia, or allogenic hematopoietic stem cell transplant. At EOT, the overall response rate was 39% and 34% in the isavuconazole and voriconazole arms, respectively, with a mean difference of \u22125.0 (95% CI, \u221218.8 to 8.9).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ETEAEs were similar between both treatment arms in patients with HM. 97% of patients in the ISA arm and 99% of patients in the VRC arm developed at least 1 TEAE; however, drug-related adverse events were greater in patients with HM who were treated with voriconazole (59%) compared with isavuconazole (44%). Significantly fewer (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .05) TEAEs of the skin, eye, and hepatobiliary system organ classes were observed in the ISA arm of the study. In the modified intent-to-treat population, 97% of the ISA patients and 98% of the VRC patients reported TEAEs. Among this population, significantly fewer (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .05) TEAEs were observed in the ISA arm than the VRC arm, including cardiac, eye, renal and urinary, and psychiatric disorders.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EIn conclusion, Dr Marr indicated that the data suggest that treatment of IFD with isavuconazole results in comparable efficacy outcomes as with voriconazole, but with a lower risk of drug-related adverse events (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Survival Rates of Patients With Hematologic Malignancy and Invasive Fungal Disease\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1254098209\u0022 data-figure-caption=\u0022Survival Rates of Patients With Hematologic Malignancy and Invasive Fungal Disease\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/14\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/14\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/14\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11832\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003ESurvival Rates of Patients With Hematologic Malignancy and Invasive Fungal Disease\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EISA, isavuconazole; VRC, voriconazole.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from K Marr, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-13\u0022\u003EDavid Andes, MD, University of Wisconsin, Madison, Wisconsin, USA, presented data from an analysis of outcomes by MICs from the SECURE trial. In this study, \u003Cem\u003EAspergillus\u003C\/em\u003E spp isolates, the majority of which were \u003Cem\u003EA. fumigatus\u003C\/em\u003E, were collected at baseline from patients enrolled in the SECURE trial for analysis of MIC values.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EIn patients treated with isavuconazole, the MIC\u003Csub\u003E50\u003C\/sub\u003E and MIC\u003Csub\u003E90\u003C\/sub\u003E values for isavuconazole were 1 and 4 \u03bcg\/mL (range, 0.25 to 32). and for voriconazole they were 1 and 2 \u03bcg\/mL (range, 0.12 to 32). In patients treated with voriconazole, the MIC\u003Csub\u003E50\u003C\/sub\u003E and MIC\u003Csub\u003E90\u003C\/sub\u003E values were 1 and 2 \u03bcg\/mL (range, 0.25 to 4) for isavuconazole and voriconazole, respectively. There was no association between baseline MIC values and all-cause mortality at day 42 or successful overall response at EOT (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11834\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11834\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11834\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003EAll-Cause Mortality Stratified by Microorganism and Minimum Inhibitory Concentrations, Through Day 42\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-19\u0022\u003EIn conclusion, Dr Andes indicated that the data from the MIC analysis of isolates from the SECURE trial demonstrated that successful outcomes were achieved with a range of MIC values, including higher values. In addition, patient outcomes were not associated with MIC value. Dr Andes pointed out that the MIC analysis was limited by its small sample size.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/28\/14.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzl13d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzl13d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzl13d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}