{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T04:14:45Z","timestamp":1749096885056,"version":"3.41.0"},"reference-count":28,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,8,10]],"date-time":"2016-08-10T00:00:00Z","timestamp":1470787200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","award":["116152"],"award-info":[{"award-number":["116152"]}],"id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2016,10]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Hepatitis C virus genotype 1a (<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>\u20101a), prior treatment, cirrhosis and post\u2010transplant status are historically associated with poor treatment responses. The new oral direct\u2010acting agents appear to be effective and safe in these patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>To evaluate the effectiveness and tolerability of simeprevir and sofosbuvir in a diverse real\u2010life cohort of patients, including difficult\u2010to\u2010treat patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a retrospective cohort study in 198 consecutive patients with hepatitis C genotype 1 (148 nontransplant, 50 post transplant), who were treated with simeprevir and sofosbuvir for 12 weeks between December 2013 and December 2014. Primary outcome was sustained virological response with undetectable<jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content>12 weeks after completion of therapy (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12). Risk factors evaluated for lack of<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 included<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>1a (vs. 1b), prior treatment (vs. none), and cirrhosis (vs. no cirrhosis).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rates were similar in non\u2010 and post\u2010transplant settings, 82% and 88%, respectively. There were no significant differences in adverse events in patients regardless of cirrhosis or transplant status. On multivariate analysis also inclusive of gender and liver transplant status, negative predictors of<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 were having at least 2 or 3 risk factors (<jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content>0.30, 95%<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>0.10\u20130.87,<jats:italic>P<\/jats:italic>= 0.027 or 0.29, 95%<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>0.09\u20130.85,<jats:italic>P<\/jats:italic>= 0.025, respectively).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Simeprevir and sofosbuvir combination is a safe and effective regimen for the treatment of non\u2010 and post\u2010transplant patients with traditional risk factors for poor treatment response, unless more than 2 difficult\u2010to\u2010treat risk factors are present.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.13761","type":"journal-article","created":{"date-parts":[[2016,8,10]],"date-time":"2016-08-10T08:33:27Z","timestamp":1470818007000},"page":"738-746","source":"Crossref","is-referenced-by-count":11,"title":["Effectiveness and tolerability of simeprevir and sofosbuvir in nontransplant and post\u2010liver transplant patients with hepatitis C genotype 1"],"prefix":"10.1111","volume":"44","author":[{"given":"G.","family":"Lutchman","sequence":"first","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N. H.","family":"Nguyen","sequence":"additional","affiliation":[{"name":"School of Medicine University of California, San Diego La Jolla CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. Y.","family":"Chang","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Daugherty","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Garcia","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Kumari","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Gupta","sequence":"additional","affiliation":[{"name":"Medical Affairs Janssen Scientific Affairs Titusville NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Doshi","sequence":"additional","affiliation":[{"name":"Health Economics &amp; Outcomes Research Janssen Scientific Affairs Titusville NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. H.","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Liver Transplant Program Stanford University Medical Center Palo Alto CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,8,10]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.510260704"},{"issue":"5","key":"e_1_2_7_3_1","doi-asserted-by":"crossref","first-page":"S35","DOI":"10.1002\/hep.1840360706","article-title":"Natural history of chronic hepatitis C","volume":"36","author":"Seeff LB","year":"2002","journal-title":"Hepatology"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/lt.23551"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2005.01202.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cld.2014.05.010"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/135965350601100811"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v17.i4.493"},{"key":"e_1_2_7_9_1","first-page":"25","article-title":"Hepatitis C: liver transplantation","volume":"427","author":"Metts J","year":"2014","journal-title":"FP Essent"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402454"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1408921"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61036-9"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1012912"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/lt.20865"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0806104"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27937"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1316366"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.05.010"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24199"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020047"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60934-8"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28422"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13300"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2015.218"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27770"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2007.01201.x"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1214854"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.10.013"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12718"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.13761","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.13761","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.13761","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T16:48:59Z","timestamp":1749055739000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.13761"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,8,10]]},"references-count":28,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2016,10]]}},"alternative-id":["10.1111\/apt.13761"],"URL":"https:\/\/doi.org\/10.1111\/apt.13761","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"type":"print","value":"0269-2813"},{"type":"electronic","value":"1365-2036"}],"subject":[],"published":{"date-parts":[[2016,8,10]]}}}