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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\u003ETreatment of cirrhotic, hepatitis C virus (HCV) genotype 1 (GT-1)-infected patients with a twice-daily oral regimen involving a single tablet of 3 direct-acting antiviral agents - the HCV NS3\/4A serine protease inhibitor ABT-450 at 150 mg plus ritonavir 100 mg plus the NS5A inhibitor ombitasvir 25 mg - along with a tablet of dasabuvir 250 mg and a tablet of ribavirin yields high rates of sustained virologic response 12 weeks following conclusion of treatment. The findings of the large, international, phase 3 TURQUOISE-II trial are discussed in this article.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials Viral Infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETreatment of cirrhotic, hepatitis C virus (HCV) genotype 1 (GT-1)-infected patients with a twice-daily oral regimen involving a single tablet of 3 direct-acting antiviral agents - the HCV NS3\/4A serine protease inhibitor ABT-450 at 150 mg plus ritonavir 100 mg plus the NS5A inhibitor ombitasvir 25 mg - along with a tablet of dasabuvir 250 mg and a tablet of ribavirin yields high rates of sustained virologic response 12 weeks following conclusion of treatment (SVR12). The high SVR12 rates occur regardless of the baseline characteristics of the patients. The findings of the large, international, phase 3 TURQUOISE-II trial were presented by Michael Fried, MD, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. The findings of the TURQUOISE-II have been published [Poordad F et al. \u003Cem\u003ENew Engl J Med.\u003C\/em\u003E 2014].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECirrhosis, high-level HCV viremia, and interleukin 28B (IL28B) non-CC genotype have been linked with lower SVR rates [Manns M et al. \u003Cem\u003ELancet\u003C\/em\u003E 2014]. These data, however, have come from small patient subsets, and information on SVR rates in difficult-to-treat populations, like null responders, is scant [Afdhal N et al. \u003Cem\u003ENew Engl J Med.\u003C\/em\u003E 2014]. TURQUOISE-II sought to evaluate the influence of baseline characteristics on treatment outcomes in HCV GT-1-infected patients with compensated cirrhosis. Patients (n = 380) were randomized to treatment with the direct-acting antiviral regimen of ABT-450 plus ritonavir plus ombitasvir along with dasabuvir, with the inclusion of 1000 or 1200 mg ribavirin according to body weight, for either 12 weeks (n = 208) or 24 weeks (n = 172). SVR 12 was assessed at week 24 and 36.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAll included patients had received \u2265 1 dose of the drugs. Influential factors that were examined included viral factors (HCV RNA level, HCV subtype), host factors (age, sex, body mass index (BMI), IL28B genotype status, prior treatment, and histories of diabetes, depression\/bipolar disorder, and intravenous drug use), and disease factors (serum albumin, platelet count, serum alpha-fetoprotein).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EBaseline characteristics in the 12- and 24-week arms were comparable in terms of sex, ethnicity, mean age, mean BMI, IL28B non-CC genotype, treatment-na\u00efve\/ experienced proportions, platelet count, serum albumin, and Child-Pugh score. The overall SVR12 rates were high.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ESVR12 was achieved in 91.6% (239\/261) and 99.2% (118\/119) of the genotype 1a and 1b patients, respectively. The rate was not significantly lower in the 12-week arm (91.8%; 191\/208) compared with the 24-week arm (96.5%; 166\/172). Consistently high viral response rates were evident at 12 and 24 weeks according to age (\u0026lt; 65 years and \u2265 65 years), sex (male and female), body mass index (\u0026lt; 30 kg\/m\u003Csup\u003E2\u003C\/sup\u003E and \u2265 30 kg\/m\u003Csup\u003E2\u003C\/sup\u003E), interleukin 28-B (IL28B) genotype, HCV subtype, baseline viral load (\u0026lt; 800 000 IU\/ mL and \u2265 800 000 IU\/mL), prior peglyated interferon and ribavirin treatment, alfa-fetoprotein (\u0026lt; 20 ng\/mL and \u2265 20 ng\/mL), and histories of diabetes, intravenous drug use, and depression\/bipolar disorder.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESVR12 was not achieved in 23 patients (17 in the 12-week arm and 6 in the 24-week arm). Associated factors as determined in a logistic regression analysis were IL28B TT genotype (\u003Cem\u003EP\u003C\/em\u003E = .021), prior null response (\u003Cem\u003EP\u003C\/em\u003E = .038), and HCV genotype 1a (\u003Cem\u003EP\u003C\/em\u003E = .046). Trends were evident for alfa-fetoprotein (\u003Cem\u003EP\u003C\/em\u003E = .059) and treatment duration (\u003Cem\u003EP\u003C\/em\u003E = .066). Overall, 2.1% of patients discontinued treatment because of adverse events.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe interferon-free regimen comprising the direct-acting antiviral regimen of ABT-450 plus ritonavir plus ombitasvir along with dasabuvir, plus ribavirin produced high SVR12 rates in a broad range of treatment-na\u00efve and -experienced cirrhotic patients. Importantly, host, viral, and disease characteristics were not influential.\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\/18.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"}