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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\u003EThe once-daily, oral, 12-week regimen using a single tablet combination of sofosbuvir (SOF; 400 mg) and ledipasvir (LDV; 90 mg) with or without ribavirin produces high sustained virologic response 12 weeks after conclusion of treatment in hepatitis C virus (HCV)-infected patients with compensated cirrhosis. This article discussed a study comprised of pooled data from the LONESTAR, ELECTRON and ELECTRON-2, ION-1 and ION-2, and SIRIUS trials.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver 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\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe once-daily, oral, 12-week regimen using a single tablet combination of the nonstructural protein 5B (NS5B) inhibitor sofosbuvir (SOF; 400 mg) and the NS5A inhibitor ledipasvir (LDV; 90 mg) with or without ribavirin (RBV) produces high sustained virologic response 12 weeks after conclusion of treatment (SVR12) in hepatitis C virus (HCV)-infected patients with compensated cirrhosis, according to Marc Bourli\u00e8re, H\u00f4pital Saint Joseph, Marseilles, France. Inclusion of RBV can boost the SVR12 at the expense of increased adverse events and declined hemoglobin count. The LDV plus SOF regimen, recently approved by the Food and Drug Administration for the treatment of chronic HCV genotype 1 infection, is safe and well tolerated in cirrhotic patients.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe present study used pooled data from the phase 2 LONESTAR trial [Lawitz E et al. \u003Cem\u003ELancet\u003C\/em\u003E 2014], phase 2 ELECTRON and ELECTRON-2 trials [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01260350\u0026amp;atom=%2Fspmdc%2F14%2F48%2F21.atom\u0022\u003ENCT01260350\u003C\/a\u003E], phase 3 GS-US-337-0113 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01975675\u0026amp;atom=%2Fspmdc%2F14%2F48%2F21.atom\u0022\u003ENCT01975675\u003C\/a\u003E], phase 3 ION-1 trial [Afdhal N et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014], phase 3 ION-2 trial [Afdhal N et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014], and phase 3 SIRIUS trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02073656\u0026amp;atom=%2Fspmdc%2F14%2F48%2F21.atom\u0022\u003ENCT02073656\u003C\/a\u003E]. The primary end point after a 12- or 24- week treatment with LDV plus SOF \u00b1 RBV was SVR12.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EOf the 513 HCV infected patients, 161 were treatment na\u00efve and 352 were treatment experienced. They were comparable at baseline concerning mean age, gender, ethnicity, mean body mass index, proportions of interleukin 28B (IL28B) CC genotype and genotype 1a, mean HCV RNA, and laboratory data. The majority (68%) of treatment-experienced patients had a prior failure of protease inhibitor therapy. SVR12 was high overall and in the 12- and 24-week groups.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ETwenty of the 513 patients (3.9%) failed to achieve SVR12. Of these, 18 relapsed, 1 was lost to follow-up, and 1 died (likely from an infection). SVR12 was not influenced by age, treatment duration, and\/or the absence\/ presence of RBV, with the exception of treatment-experienced patients treated for 12 weeks with LDV plus SOF. Genotype in both the absence and presence of RBV was not influential. For treatment-experienced patients, prior failure of protease inhibitor therapy was not influential. Lower SVR12 was noted in patients with a platelet count \u0026lt; 75 \u00d7 10\u003Csup\u003E3\u003C\/sup\u003E per \u03bcL.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe inclusion\/absence of RBV had no effect on the frequency of adverse events in general and on grade \u2265 3 adverse events. RBV was associated with more adverse events that prompted discontinuation (n = 3, 1% vs n = 38, 15%) and decline of hemoglobin to \u0026lt; 10 g\/dL (n = 1, \u0026lt; 1%, versus n = 26, 10%). Adverse events occurring in more than 10% overall and in either patient group predominantly included headache, fatigue, asthenia, insomnia, and nausea. The presence of RBV was associated with a greater prevalence of pruritus and rash.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe pooled data revealed an SVR12 of 96% overall. In treatment-experienced patients, the 12-week LDV plus SOF regimen produced a 90% SVR12. The rate was boosted to \u2265 96% by the inclusion of RBV at the expense of more frequent adverse events and hemoglobin decline. The LDV plus SOF combination is thus judged to be safe and effective for HCV-infected patients with compensated cirrhosis. The similar findings from the 12- and 24-week treatments indicate that the shorter treatment period is acceptable.\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\/21.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?nzofs2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}