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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\u003EBoth the PILLAR [TMC435-C205; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00882908\u0026amp;atom=%2Fspmdc%2F11%2F12%2F14.atom\u0022\u003ENCT00882908\u003C\/a\u003E] and ASPIRE [TMC435-C206; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00980330\u0026amp;atom=%2Fspmdc%2F11%2F12%2F14.atom\u0022\u003ENCT00980330\u003C\/a\u003E] trials demonstrated that TMC435 (an oral inhibitor of the hepatitis C virus NS3\/4A protease) administered once-daily with pegylated interferon alpha-2a (PegIFNa-2a) and ribavirin (RBV) is safe, has potent antiviral activity, and shortens total treatment by 24 weeks compared with PegIFNa-2a\/RBV alone.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EMichael W Fried, MD, University of North Carolina, Chapel Hill, North Carolina, USA, presented the results of the PILLAR [TMC435-C205; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00882908\u0026amp;atom=%2Fspmdc%2F11%2F12%2F14.atom\u0022\u003ENCT00882908\u003C\/a\u003E and ASPIRE [TMC435-C206; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00980330\u0026amp;atom=%2Fspmdc%2F11%2F12%2F14.atom\u0022\u003ENCT00980330\u003C\/a\u003E] trials. Both studies demonstrated that TMC435 (an oral inhibitor of the hepatitis C virus [HCV] NS3\/4A protease) administered once-daily with pegylated interferon alpha-2a (PegIFNa-2a) and ribavirin (RBV) is safe, has potent antiviral activity, and shortens total treatment by 24 weeks compared with PegIFNa-2a\/RBV alone.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe two trials were international, randomized, double-blind studies that enrolled men and women, aged 18 to 70 years who were chronically infected with HCV genotype 1 (plasma HCV RNA \u0026gt;100,000 IU\/mL at screening). In the PILLAR trial, patients were HCV treatment-na\u00efve and received TMC435 for 12 or 24 weeks with PegIFNa-2a\/RBV. In the ASPIRE trial, patients were HCV treatment-experienced, although na\u00efve to direct-acting antivirals. The participants were stratified by prior virological response (relapsers, partial responders, null responders). TMC435 with PegIFNa-2a\/RBV was administered for 12, 24, or 48 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary efficacy endpoint, which was the same in both studies, was the proportion of patients with undetectable HCV RNA (\u0026lt;25 IU\/mL) 24 weeks after the planned end of treatment. Secondary objectives included an evaluation of the safety and tolerability of TMC435 plus PegIFNa-2a\/RBV compared with PegIFNa-2a\/RBV\/placebo over the trial period. Virologic response rates and 95% confidence intervals were calculated using a logistic regression model, including baseline HCV RNA and the stratification factors as covariates. The results of planned interim 24-week efficacy and safety analyses, including the proportion of patients with undetectable HCV RNA (\u0026lt;25 IU\/mL) at Weeks 4, 12, and 24, from both studies were reported.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn the PILLAR trial, 68 to 79% of patients who were treated with TMC435 achieved a rapid virologic response (HCV RNA \u0026lt;25 IU\/mL) compared with 5% in the control arm at Week 4.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAt Week 12, rapid virologic response was 91% to 97% for the TMC435 arms compared with 58% in the control arm, and at Week 24, rapid virologic response was 94% to 97% for the TMC435 arms compared with 82% in the control arm. In the TMC435 arms, 79% to 86% of subjects were eligible to stop treatment by Week 24.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIn the ASPIRE trial, at Weeks 4, 12, and 24, significantly higher virologic response rates were observed following active treatment compared with placebo plus PegIFNa-2a\/RBV. In null and partial responders, higher virologic response rates were observed in the TMC435 150-mg dose arms, compared with 100-mg dose arms, at early time points.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe distribution of the IL28B genotype (TT, CC, and CT) was similar across treatment groups with the higher responses rates for the CC genotype in the placebo arms. In the TMC435 groups, higher-than placebo responses were observed in the TT, CC, and CT categories, with no major differences between IL28B genotypes.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EGiven in combination with PegIFNa-2a\/RBV, the safety and tolerability profile of TMC435 was generally similar to those of the placebo control. In treatment-na\u00efve and treatment-experienced patients, TMC435, administered once-daily with PegIFNa-2a\/RBV, has potent antiviral activity, rapidly achieving undetectable HCV RNA levels in the majority of patients.\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\/11\/12\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the 51st ICAAC presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-113237378\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;The editors would like to thank the many members of the 51\u0026amp;lt;sup\u0026amp;gt;st\u0026amp;lt;\/sup\u0026amp;gt; ICAAC presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure1\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/12\/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\/11\/12\/14\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure1\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\/11\/12\/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\/12529\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\n            \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the 51\u003Csup\u003Est\u003C\/sup\u003E ICAAC presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\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\/11\/12\/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?nzmx5d\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?nzmx5d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}