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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\u003EA 3-drug (3D) regimen of ABT-450, co-dosed with ritonavir, ombitasvir and dasabuvir has been given alone or in combination with ribavirin (RBV) and studied in 6 phase 3 trials of more than 2700 patients. The 3D regimen is safe and effective in patients infected with hepatitis C virus (HCV) genotype 1a with or without cirrhosis. However, efficacy of this treatment may be variably influenced by HCV genotype subtype, treatment experience (na\u00efve vs experienced), and stage of fibrosis (early fibrosis vs cirrhosis). This article discusses an analysis of the SAPPHIRE-I and -II, PEARL-IV, and TURQUOISE-II trials to examine the impact of RBV in noncirrhotic patients and treatment duration in cirrhotic patients.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials Liver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA 3-drug (3D) regimen of ABT-450, an NS3\/4A protease inhibitor, co-dosed with ritonavir, ombitasvir, an NS5A inhibitor, and dasabuvir, a non-nucleoside NS5B polymerase inhibitor has been given alone or in combination with ribavirin (RBV) and studied in 6 phase 3 trials of more than 2700 patients. The 3D regimen is safe and effective in patients infected with hepatitis C virus (HCV) genotype 1a with or without cirrhosis. However, efficacy of this treatment may be variably influenced by HCV genotype subtype, treatment experience (na\u00efve vs experienced), and stage of fibrosis (early fibrosis vs cirrhosis).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EIn this analysis, data from 1058 patients with HCV genotype 1a from 4 phase 3 trials were pooled to examine the impact of RBV in noncirrhotic patients and treatment duration in cirrhotic patients. The studies were SAPPHIRE-I and -II [Feld JJ et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014; Zeuzem S et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014], PEARL-IV [Ferenci P et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014], and TURQUOISE-II [Poordad F et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014] (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Gregory Everson, MD, University of Colorado, Denver, Colorado, USA, presented the results.\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\/15573\/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\/15573\/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\/15573\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-4\u0022 class=\u0022first-child\u0022\u003EThe Pooled Studies\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003EKey inclusion criteria for this study were chronic HCV infection with genotype 1a, age 18 to 70 years, and plasma HCV RNA \u0026gt; 10 000 IU\/mL. Key exclusion criteria were infection with hepatitis B virus or human immunodeficiency virus.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPATIENTS WITHOUT CIRRHOSIS\u003C\/h2\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe 3D regimen was administered for 12 weeks with or without RBV. Overall, the rates of SVR12 with and without RBV were 96.0% (569\/593) and 90.1% (182\/202) (\u003Cem\u003EP\u003C\/em\u003E = .004). In treatment-na\u00efve patients, rates of SVR12 were 96.0% (403\/420) and 90.1% (182\/202) (\u003Cem\u003EP\u003C\/em\u003E = .0 0 6), respectively. All treatment-experienced patients were given RBV, and rates of SVR12 were 94% for relapsers, 100% for partial responders, and 95.4% for null responders. RBV dose modification was required in 6.7% of RBV-treated patients, but, despite the dose modification, 97.6% of these patients achieved SVR12. In multivariable analyses, high baseline body mass index and RBV-free treatment were associated with lower likelihood of achieving SV R12 (\u003Cem\u003EP\u003C\/em\u003E = .005 and \u003Cem\u003EP\u003C\/em\u003E = .007, respectively). Adverse events and related discontinuations were generally mild and were more common in RBV-containing treatment.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPATIENTS WITH CIRRHOSIS\u003C\/h2\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EAll of the patients with cirrhosis were treated with RBV, and treatment durations of 12 and 24 weeks were compared (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The overall rates of SVR12 were 88.7% for 12 weeks and 95% for 24 weeks (\u003Cem\u003EP\u003C\/em\u003E = .08). The lower SVR12 with 12 weeks was mainly evident in the treatment-experienced patients with prior null response, 80.0% versus 92.9% for 12 versus 24 weeks of treatment (\u003Cem\u003EP\u003C\/em\u003E = .13). Rates of SVR12 in the treatment-na\u00efve patients were 92.4% and 94.6% for 12 and 24 weeks of treatment, respectively.\u003C\/p\u003E\n         \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\/48\/20\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022SVR12 Rates in Cirrhotic HCV1a-Infected Treatment-Na\u0026#xEF;ve and Treatment-Experienced Patients Treated for 12 or 24 Weeks\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2096461137\u0022 data-figure-caption=\u0022SVR12 Rates in Cirrhotic HCV1a-Infected Treatment-Na\u0026#xEF;ve and Treatment-Experienced Patients Treated for 12 or 24 Weeks\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\/48\/20\/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\/48\/20\/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\/48\/20\/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\/15572\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-9\u0022 class=\u0022first-child\u0022\u003ESVR12 Rates in Cirrhotic HCV1a-Infected Treatment-Na\u00efve and Treatment-Experienced Patients Treated for 12 or 24 Weeks\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003E3D, 3-drug direct-acting antiviral regimen; HCV1a, hepatitis C virus genotype 1a; PegIFN, pegylated interferon; RBV, ribavirin; SVR12, sustained virologic response at week 12.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EIn multivariable analyses, the TT IL28B genotype and a prior null response to peginterferon\/RBV therapy were associated with failure to achieve SVR12 (\u003Cem\u003EP\u003C\/em\u003E = .008 and \u003Cem\u003EP\u003C\/em\u003E = .009, respectively). Adverse events and event-related discontinuation were similar for both treatment durations.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThis pooled analysis of 4 phase 3 trials of patients infected with HCV genotype 1a indicates that the rate of SVR in noncirrhotic patients treated with the 3D regimen may be enhanced by addition of RBV. In addition, in patients with cirrhosis, extension of 3D + RBV to 24 weeks may be warranted, especially for those who were prior null responders to peginterferon\/RBV.\u003C\/p\u003E\n      \u003C\/div\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\/20.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?nzofs2\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?nzofs2\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?nzofs2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}