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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\u003Cp id=\u0022p-1\u0022\u003EResults of the ALLY 2 trial involving more than 200 patients co-infected with HIV\/HCV shows the efficacy and safety of the combined 12-week use of daclatasvir and sofosbuvir, with sustained virologic response for 12 weeks of 97% after a 12-week treatment. The benefit for HCV infection does not compromise the ongoing antiretroviral therapy.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ehepatitis C virus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHCV\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHIV\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eco-infection\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edaclatasvir\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esofosbuvir\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENS5A\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecombination antiretroviral therapy\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EcART\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EALLY 2\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT02032888\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egastroenterology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EKenneth Sherman, MD, PhD, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA, presented the findings of ALLY 2 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02032888\u0026amp;atom=%2Fspmdc%2F15%2F14%2F9.atom\u0022\u003ENCT02032888\u003C\/a\u003E], a phase 3, randomized, open-label clinical trial, which demonstrated a sustained virologic response for 12 weeks (SVR12) in 97% of patients coinfected with genotypes 1 to 4 hepatitis C virus (HCV) and HIV. Patients were treated with the NS5A inhibitor daclatasvir (DCV) and NS5B inhibitor sofosbuvir (SOF), which allowed for treatment without having to modify the combination antiretroviral therapy (cART) regimen.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAbout 130 to 150 million people are infected with chronic HCV worldwide [WHO. \u003Ca href=\u0022http:\/\/www.who.int\/mediacentre\/factsheets\/fs164\/en\/\u0022\u003Ehttp:\/\/www.who.int\/mediacentre\/factsheets\/fs164\/en\/\u003C\/a\u003E. Accessed June 3, 2015], including an estimated 3 to 4 million in the United States [CDC. \u003Ca href=\u0022http:\/\/www.cdc.gov\/hepatitis\/hcv\/statisticshcv.htm\u0022\u003Ehttp:\/\/www.cdc.gov\/hepatitis\/hcv\/statisticshcv.htm\u003C\/a\u003E. Accessed June 3, 2015]. Up to 20% of people with chronic HCV will develop cirrhosis, with about the same proportion progressing to liver cancer [WHO. \u003Ca href=\u0022http:\/\/www.who.int\/mediacentre\/factsheets\/fs164\/en\/\u0022\u003Ehttp:\/\/www.who.int\/mediacentre\/factsheets\/fs164\/en\/\u003C\/a\u003E. Accessed June 3, 2015].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EHIV\/HCV coinfection accelerates progression of HCV liver disease [Mac\u00edas J et al. \u003Cem\u003EHepatology\u003C\/em\u003E. 2009] and hinders pegylated interferon treatment [Grint D et al. \u003Cem\u003EHIV Med\u003C\/em\u003E. 2013]. A treatment regimen directed at HIV\/HCV co-infected patients must not compromise cART. The positive efficacy and safety results of the DCV\u2005+\u2005SOF combination in chronic HCV monoinfection [Sulkowski MS et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2014] prompted ALLY 2, which evaluated the combination treatment in HIV\/HCV coinfected patients on a broad range of antiretroviral therapies.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe ALLY 2 trial involved 203 patients who were treatment-na\u00efve for HCV (n\u2005=\u2005151) or who had been treated previously (n\u2005=\u200552). The treatment-na\u00efve patients were randomized 2:1 to DCV 30\/60\/90 mg plus SOF 400 mg QD for either 12 weeks (n\u2005=\u2005101) or 8 weeks (n\u2005=\u200550). The treatment-experienced patients received 12 weeks of therapy. The standard DCV dose was 60 mg, with the dose being adjusted according to cART: 30 mg in those receiving ritonavir-boosted protease inhibitors and 90 mg when cART included nonnucleoside reverse transcriptase inhibitors, except for rilpivirine. At baseline, the 3 arms were comparable in demographic, clinical, and prior HIV treatment characteristics. The primary end point, SVR12 in the treatment-na\u00efve patients with HCV genotype 1 treated for 12 weeks, was 96% (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\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\/15\/14\/9\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022ALLY 2 Results: SVR12 (Intention to Treat) by Treatment GroupSVR12, sustained virologic response for 12 wk.Reproduced with permission from K Sherman, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-829751301\u0022 data-figure-caption=\u0022ALLY 2 Results: SVR12 (Intention to Treat) by Treatment GroupSVR12, sustained virologic response for 12 wk.Reproduced with permission from K Sherman, MD.\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\/15\/14\/9\/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\/15\/14\/9\/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\/15\/14\/9\/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\/16805\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\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EALLY 2 Results: SVR12 (Intention to Treat) by Treatment Group\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESVR12, sustained virologic response for 12 wk.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EReproduced with permission from K Sherman, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003EPatients with baseline NS5A resistant-associated variants achieved SVR12 at a rate of 96% (22\/23) when treated for 12 weeks, and 70% (7\/10) when treated for 8 weeks. Treatments did not compromise HIV control, as indicated by the unwavering mean CD4 count and continued HIV virologic suppression throughout the treatment period.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe frequency of serious adverse events was low, occurring in 1.0%, 5.8%, and 0.0% of the na\u00efve\/12-week, experienced\/12-week, and na\u00efve\/8-week arms, respectively. The adverse events commonly comprised fatigue, nausea, headache, and diarrhea. One death occurred after stopping study treatment in the 8-week arm as a result of treatment-unrelated cardiac arrest.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EALLY 2 provides evidence of the efficacy and safety of the DCV\u2005+\u2005SOF combination in patients coinfected with HIV\/HCV, whether or not they had been treated before for HCV. The treatment benefit does not come at the expense of compromised treatment of HIV infection.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\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\/15\/14\/9.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?nzlh4c\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?nzlh4c\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}