{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T22:14:25Z","timestamp":1762899265761},"reference-count":20,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2016,6,16]],"date-time":"2016-06-16T00:00:00Z","timestamp":1466035200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006970","name":"Ikaria","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006970","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2016,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aims<\/jats:title><jats:p>Many currently available direct\u2010acting antiviral (<jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content>) regimens are less effective against <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> genotype 3 than against other <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> genotypes. The all\u2010oral, pangenotypic <jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content> combination of daclatasvir (<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A inhibitor) + sofosbuvir (nucleotide <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5B inhibitor) was studied in genotype 3\u2013infected treatment\u2010naive and \u2010experienced patients (<jats:styled-content style=\"fixed-case\">ALLY<\/jats:styled-content>\u20103) who achieved rates of sustained virological response at post\u2010treatment Week 12 (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12) of 90 and 86% respectively. In this analysis, we assessed whether on\u2010treatment responses to daclatasvir + sofosbuvir in genotype 3\u2013infected patients could predict treatment outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In <jats:styled-content style=\"fixed-case\">ALLY<\/jats:styled-content>\u20103, treatment\u2010naive and \u2010experienced patients, with or without cirrhosis, were treated with daclatasvir + sofosbuvir for 12 weeks. <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> kinetics and categorical virological responses on treatment were assessed. The proportions of responders and nonresponders by study week, and time to first undetectable <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content>, were analysed for utility in predicting treatment outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> levels declined rapidly during Week 1 of treatment in both treatment\u2010naive and \u2010experienced cohorts. Although patients with cirrhosis had a slower initial virological response as measured by the proportion of patients with <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> below the lower limit of quantification at Week 1, responses converged thereafter. Positive and negative predictive values calculated for on\u2010treatment responses were generally comparable with the overall <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rate and were therefore limited indicators of outcome. <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rates were not impacted by time to first undetectable <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>On\u2010treatment responses are not useful predictors of ultimate virological response to the daclatasvir + sofosbuvir regimen.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13165","type":"journal-article","created":{"date-parts":[[2016,5,18]],"date-time":"2016-05-18T05:28:34Z","timestamp":1463549314000},"page":"1611-1618","source":"Crossref","is-referenced-by-count":22,"title":["On\u2010treatment <scp>HCV RNA<\/scp> as a predictor of sustained virological response in <scp>HCV<\/scp> genotype 3\u2013infected patients treated with daclatasvir and sofosbuvir"],"prefix":"10.1111","volume":"36","author":[{"given":"Kris V.","family":"Kowdley","sequence":"first","affiliation":[{"name":"Swedish Medical Center Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David R.","family":"Nelson","sequence":"additional","affiliation":[{"name":"University of Florida Gainesville FL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacob P.","family":"Lalezari","sequence":"additional","affiliation":[{"name":"Quest Clinical Research San Francisco CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terry","family":"Box","sequence":"additional","affiliation":[{"name":"Clinical Research Centers of America LLC Murray UT USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norman","family":"Gitlin","sequence":"additional","affiliation":[{"name":"Atlanta Gastroenterology Associates Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Poleynard","sequence":"additional","affiliation":[{"name":"Digestive Health Specialists Winston\u2010Salem NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mordechai","family":"Rabinovitz","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natarajan","family":"Ravendhran","sequence":"additional","affiliation":[{"name":"Digestive Disease Associates Baltimore MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aasim M.","family":"Sheikh","sequence":"additional","affiliation":[{"name":"Gastrointestinal Specialists of Georgia Marietta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asma","family":"Siddique","sequence":"additional","affiliation":[{"name":"Virginia Mason Medical Center Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafia","family":"Bhore","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Noviello","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khurram","family":"Rana","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Wallingford CT USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,6,16]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.12405"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1478-3231.2011.02537.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2011.01441.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2009.05.016"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2005.069757"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1316145"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27726"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.12632"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa066403"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2015.03.025"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28473"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa042608"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1014463"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1010494"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-015-0328-9"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(13)70033-1"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ170"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.04.006"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2014.11.027"},{"key":"e_1_2_8_21_1","first-page":"1394A","article-title":"Complete cure after three weeks of all\u2010oral triple\u2010direct acting antiviral regimens in non\u2010cirrhotic chronic hepatitis C genotpye 1b chinese subjects (SODAPI study)","volume":"62","author":"Lau GK","year":"2015","journal-title":"Hepatology"}],"container-title":["Liver International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fliv.13165","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fliv.13165","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/liv.13165","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T13:21:56Z","timestamp":1695561716000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/liv.13165"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6,16]]},"references-count":20,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2016,11]]}},"alternative-id":["10.1111\/liv.13165"],"URL":"https:\/\/doi.org\/10.1111\/liv.13165","archive":["Portico"],"relation":{},"ISSN":["1478-3223","1478-3231"],"issn-type":[{"value":"1478-3223","type":"print"},{"value":"1478-3231","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6,16]]}}}