{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:51:18Z","timestamp":1772160678176,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,7,27]],"date-time":"2016-07-27T00:00:00Z","timestamp":1469577600000},"content-version":"vor","delay-in-days":26,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aim:<\/jats:title>\n                    <jats:p>Pegylated\u2010interferon\u2010alpha plus ribavirin is the current standard\u2010of\u2010care regimen for treating chronic hepatitis C virus (HCV) infection in Taiwan; however, interferon\u2010based regimens can be poorly tolerated. The interferon\u2010free, two\u2010drug, fixed\u2010dose combination tablet ledipasvir\/sofosbuvir is approved in Europe, the USA, and Japan for treating chronic genotype 1 HCV infection. Little is known about its efficacy\/safety in Taiwanese patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      In this multicenter, open\u2010label, phase 3b (NCT02021656) study, 85 Taiwanese patients (\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u200942, treatment\u2010na\u00efve;\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u200943, treatment\u2010experienced) with chronic genotype 1 HCV infection (\u00b1compensated cirrhosis) received 12\u2009weeks of ledipasvir\/sofosbuvir fixed\u2010dose combination tablet. The primary efficacy end point was the proportion of patients with sustained virologic response 12\u2009weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were collected.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The overall SVR12 rate was 98% (83\/85), with 100% (42\/42) and 95% (41\/43) of treatment\u2010na\u00efve and treatment\u2010experienced patients, respectively, achieving SVR12. There were no on\u2010treatment virologic failures. One patient relapsed after treatment discontinuation; one patient withdrew consent on day 2. The most common treatment\u2010emergent adverse event (AE) was headache (14%, 12\/85). There was one grade 3 AE (small cell lung cancer unrelated to ledipasvir\/sofosbuvir), no grade 4 AEs, and four grade 3\u20134 laboratory abnormalities. Only the patient with small cell lung cancer prematurely discontinued treatment. Two patients reported three serious AEs; none was considered related to ledipasvir\/sofosbuvir.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Data from this phase 3b study suggest that 12\u2009weeks of once\u2010daily treatment with the interferon\u2010free, ribavirin\u2010free regimen ledipasvir\/sofosbuvir is effective and well\u2010tolerated in Taiwanese patients with chronic genotype 1 HCV infection, irrespective of treatment history.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgh.13305","type":"journal-article","created":{"date-parts":[[2016,2,3]],"date-time":"2016-02-03T22:57:38Z","timestamp":1454540258000},"page":"1323-1329","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Ledipasvir\/sofosbuvir fixed\u2010dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus"],"prefix":"10.1111","volume":"31","author":[{"given":"Wan\u2010Long","family":"Chuang","sequence":"first","affiliation":[{"name":"Kaohsiung Medical University Hospital, Kaohsiung Medical University  Kaohsiung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rong\u2010Nan","family":"Chien","sequence":"additional","affiliation":[{"name":"Liver Research Unit Chang Gung Memorial Hospital\u2010Keelung  Keelung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng\u2010Yuan","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine School of Medicine, China Medical University  Taichung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting\u2010Tsung","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine National Cheng Kung University Hospital  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gin\u2010Ho","family":"Lo","sequence":"additional","affiliation":[{"name":"Department of Medicine, E\u2010Da Hospital  Kaohsiung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I\u2010Shyan","family":"Sheen","sequence":"additional","affiliation":[{"name":"Chang Gung Memorial Hospital and Medical College Chang Gung University  Taoyuan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Horng\u2010Yuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Mackay Memorial Hospital  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jyh\u2010Jou","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chi Mei Hospital  Liouying Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenny C.","family":"Yang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven J.","family":"Knox","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bing","family":"Gao","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly L.","family":"Garrison","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongmei","family":"Mo","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Phillip S.","family":"Pang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu\u2010Chun","family":"Hsu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Changhua Christian Hospital  Changhua Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tsung\u2010Hui","family":"Hu","sequence":"additional","affiliation":[{"name":"Chang Gung Medical Foundation  Kaohsiung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chi\u2010Jen","family":"Chu","sequence":"additional","affiliation":[{"name":"Department of Medicine Taipei Veterans General Hospital and National Yang\u2010Ming University, School of Medicine  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia\u2010Horng","family":"Kao","sequence":"additional","affiliation":[{"name":"National Taiwan University College of Medicine and Hospital  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,7,27]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2010.03432.x"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0929-6646(09)60231-X"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jfma.2015.06.012"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.1500"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jis385"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.28753"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.2001"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12072-012-9342-y"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1086\/592579"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.10.049"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22319"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06102-5"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-140-5-200403020-00010"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020047"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1746.2009.05789.x"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1100349108"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/gene.2011.1"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.3851\/IMP1741"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2893.2003.00387.x"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-015-0888-x"},{"key":"e_1_2_6_22_1","volume-title":"HARVONI (ledipasvir\/sofosbuvir) Summary of Product Characteristics","author":"Gilead Sciences International Ltd","year":"2014"},{"key":"e_1_2_6_23_1","volume-title":"HARVONI (ledipasvir and sofosbuvir) Prescribing Information","author":"Gilead Sciences, Inc","year":"2014"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402454"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402355"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1316366"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(15)70099-X"},{"key":"e_1_2_6_28_1","article-title":"A phase 3b study of ledipasvir\/sofosbuvir fixed\u2010dose combination tablet in treatment\u2010na\u00efve and treatment\u2010experienced Korean patients chronically infected with genotype 1 hepatitis C virus","author":"Lim Y\u2010S","journal-title":"J. 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