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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\u003EDaclatasvir is a pangenotypic (genotypes [GT] 1\u20136 in vitro and GT 1\u20134 in clinical trials) NS5A inhibitor with a low potential for drug-drug interactions. It is approved in Europe and Japan, and it is under regulatory review in the United States. The aim of the phase 3 UNITY-1 trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01979939\u0026amp;atom=%2Fspmdc%2F14%2F48%2F15.atom\u0022\u003ENCT01979939\u003C\/a\u003E] was to evaluate this all-oral, ribavirin-free combination in noncirrhotic treatment-na\u00efve and treatment-experienced patients with hepatitis C virus (HCV) genotype (GT) 1 infection.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETwelve weeks of treatment with the all-oral combination of daclatasvir (DCV), asunaprevir (ASV), and beclabuvir (BCV) resulted in sustained virologic response (SVR12) rates of \u0026gt; 92% in treatment-na\u00efve patients with hepatitis C virus (HCV) genotype (GT) 1 and 100% in patients with HCV genotype 4 in phase 2 studies [Everson GT et al. AASLD. 2013 LB-1; Hassanein T et al. EASL. 2014]. The aim of the phase 3 UNITY-1 trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01979939\u0026amp;atom=%2Fspmdc%2F14%2F48%2F15.atom\u0022\u003ENCT01979939\u003C\/a\u003E], presented by Fred Poordad, MD, University of Texas Health Sciences Center, San Antonio, Texas, USA, was to evaluate this all-oral, ribavirin-free combination in noncirrhotic treatment-na\u00efve and treatment-experienced patients with HCV GT 1 infection.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EDCV is a pangenotypic (genotypes [GT] 1\u20136 in vitro and GT 1\u20134 in clinical trials) NS5A inhibitor with a low potential for drug-drug interactions. It is approved in Europe and Japan, and it is under regulatory review in the United States. ASV is an N53 protease inhibitor with clinical data available for GT 1 and 4. BCV is a nonnucleoside NS5B polymerase inhibitor with clinical data available for GT 1 and 4. DCV\/ASV\/ BCV is coformulated as a twice-daily, fixed-dose combination (FDC).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the UNITY-1 trial, 312 treatment-na\u00efve patients and 103 treatment-experienced patients were treated with DCV 30 mg\/ASV 200 mg\/BCV 75 mg FDC (DCV-TRIO) for 12 weeks and followed through week 48. The primary end point was SVR12, defined as HCV RNA \u0026lt; lower limit of quantitation (LLOQ) at posttreatment week 12, in treatment-na\u00efve patients. The secondary end point was SVR12 in treatment-experienced patients.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAll enrolled patients were aged \u2265 18 years, the median age was 55 years, and 58% were male. All patients had HCV RNA \u2265 10 000 IU\/mL. Most of the patients (73%) were infected with HCV GT 1a. Most treatment-na\u00efve and treatment-experienced patients had the non-CC \u003Cem\u003EIL28B\u003C\/em\u003E GT. Treatment was completed by 97% of the patients. Eight patients discontinued due to lack of efficacy. Overall, SVR12 was achieved by 91% of the patients.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe SVR12 rate in treatment-na\u00efve patients was 92%, significantly higher than the historic threshold rate of 79% (based on analysis of sofosbuvir plus peginterferon\/ribavirin data). A significantly higher SVR12 rate of 89% was achieved in treatment-experienced patients, compared with the historic threshold rate of 48% (based on analysis of simeprevir plus peginterferon\/ribavirin data).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESVR12 rates of 98% to 100% were observed in treatment-na\u00efve and treatment-experienced patients with HCV GT 1b. SVR12 rates were comparable with respect to gender, age, race, baseline HCV RNA, and \u003Cem\u003EIL28B\u003C\/em\u003E genotype. On-treatment virologic breakthrough occurred in 2% of both treatment-na\u00efve and -experienced patients. Posttreatment relapse occurred in 5% and 15% of treatment-na\u00efve and -experienced patients, respectively. The most frequently observed resistance-associated variants among GT 1a patients were NS5A-Q30, NS3-R155, and NS5B-P495.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003ETreatment with the all-oral, ribavirin-free, fixed-dose DCV-TRIO for 12 weeks achieved an SVR12 of 91% in noncirrhotic patients with HCV genotype 1. DCV-TRIO was generally safe and well tolerated.\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\/48\/15.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_openurl.js?nzofi1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}