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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\u003Cp id=\u0022p-1\u0022\u003EMultivariate analysis shows that \u0026gt;\u20052000 patients with hepatitis C virus who received 3 direct-acting antivirals and had \u0026lt;4 predictors of negative response experienced 12-week sustained virologic response rates \u0026gt;\u200595%. Analysis of those that received the label-recommended regimen found that the only 2 negative predictors associated with significantly lower response rates are obesity and genotype 1a disease. Even those with both factors achieved sustained virologic response rates of 95% at week 12.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ehepatitis C virus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esubgenotype\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Enegative predictors\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eombitasvir\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eparitaprevir\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edasabuvir\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESAPPHIRE-I\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESAPPHIRE-II\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPEARL-II\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPEARL-III\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPEARL-IV\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETURQUOISE-II\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egastroenterology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EThe multitargeted regimen of 3 direct-acting antivirals\u2014ombitasvir (an NS5A inhibitor), dasabuvir (a nonnucleoside NS5B RNA polymerase inhibitor), and paritaprevir (an NS3\/4A protease inhibitor boosted with ritonavir), with or without ribovarin\u2014has demonstrated high efficacy in 6 phase 3 clinical trials encompassing \u0026gt;\u20052000 patients with genotype 1 hepatitis C virus (HCV; \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\/16803\/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\/16803\/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\/16803\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 \u003Cp id=\u0022p-3\u0022 class=\u0022first-child\u0022\u003EOverview of Treatment Regimens and SVR12 Rates in 6 Phase 3 Trials\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003ENancy Reau, MD, The University of Chicago Medicine, Chicago, Illinois, USA, presented a composite review of data from the 6 trials that examined whether multiple predictors of response had a meaningful impact on sustained virologic response at week 12 (SVR12). These predictors\u2014traditionally associated with less robust clinical outcomes in patients with HCV\u2014include cirrhosis, high baseline viral load, weight, \u003Cem\u003EIL28B\u003C\/em\u003E non-CC genotype, and prior treatment failure.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EA multivariate stepwise logistic regression was performed on data from the 2053 patients who participated in all 6 trials. The analysis included 22 continuous and categorical variables performed on 2 populations: (1) all patients who had data available regardless of whether they had received a label-recommended regimen and (2) patients who received a label-recommended regimen by HCV subgenotype and cirrhosis status.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EAnalysis of the entire cohort found that while genotype 1a disease was independently and significantly associated with reduced SVR12 (94%; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001), the SVR12 rate for genotype 1b was 99%. Other factors associated with significantly lower SVR12 included higher weight at baseline (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.007), \u003Cem\u003EIL28B\u003C\/em\u003E TT genotype (\u003Cem\u003EP\u2005\u003C\/em\u003E=\u2005.034), Hispanic\/Latino ethnicity (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.013), and higher baseline HCV RNA (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.041). Traditional factors associated with lower cure rates, such as the presence of cirrhosis and prior treatment response, were not associated with lower SVR rates.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe SVR12 rates for the entire cohort by the cumulative number of individual negative predictors are shown in \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\/15\/14\/8\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022SVR12 Rates per Cumulative Number of Negative PredictorsHCV, hepatitis C virus; SVR12, sustained virologic response for 12 wk.aNegative predictors: HCV genotype 1a, weight \u0026#x2265;\u0026#x2005;75 kg, IL28B TT, Hispanic\/Latino, HCV RNA \u0026#x2265;\u0026#x2005;800\u0026#x2005;000 IU\/mL.Reproduced with permission from N Reau, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-223082138\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;SVR12 Rates per Cumulative Number of Negative PredictorsHCV, hepatitis C virus; SVR12, sustained virologic response for 12 wk.\u0026amp;lt;sup\u0026amp;gt;a\u0026amp;lt;\/sup\u0026amp;gt;Negative predictors: HCV genotype 1a, weight \u0026#x2265;\u0026#x2005;75 kg, \u0026amp;lt;em\u0026amp;gt;IL28B TT\u0026amp;lt;\/em\u0026amp;gt;, Hispanic\/Latino, HCV RNA \u0026#x2265;\u0026#x2005;800\u0026#x2005;000 IU\/mL.Reproduced with permission from N Reau, MD.\u0026amp;lt;\/div\u0026amp;gt;\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\/15\/14\/8\/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\/15\/14\/8\/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\/15\/14\/8\/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\/16802\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\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003ESVR12 Rates per Cumulative Number of Negative Predictors\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EHCV, hepatitis C virus; SVR12, sustained virologic response for 12 wk.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003E\u003Csup\u003Ea\u003C\/sup\u003ENegative predictors: HCV genotype 1a, weight \u2265\u200575 kg, \u003Cem\u003EIL28B TT\u003C\/em\u003E, Hispanic\/Latino, HCV RNA \u2265\u2005800\u2005000 IU\/mL.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EReproduced with permission from N Reau, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-14\u0022\u003EAmong \u0026gt;\u20052000 patients in the studies, 1083 received the label-recommended regimen (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E). The overall rate of SVR12 among those patients was 97% (n\u2005=\u20051052), with rates similarly high regardless of whether cirrhosis was present. Only 1 patient with a genotype 1b infection did not achieve SVR12. Of the 31 patients who did not achieve SVR12, 19 (1.8%) had on-treatment breakthrough or posttreatment relapse; 12 (1.1%) discontinued treatment prematurely. Of these 12 discontinuations, 3 were due to adverse events. Of the 22 variables, only body mass index and HCV genotype 1a disease had a negative impact in the multivariate stepwise analysis.\u003C\/p\u003E\u003Cdiv id=\u0022T2\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\/16804\/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\/16804\/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\/16804\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 2.\u003C\/span\u003E \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003ELabel-Recommended Regimens\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-19\u0022\u003EAccording to Dr Reau, these data suggest that the regimen of 3 direct-acting antivirals with or without ribovarin confers high SVR12 rates and offers an effective treatment option for patients with HCV who present with factors previously thought to have an negative impact on treatment response.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\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\/15\/14\/8.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?nzlh4c\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?nzlh4c\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?nzlh4c\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}