{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:16:00Z","timestamp":1787015760840,"version":"build-2736575974"},"reference-count":34,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,2,22]],"date-time":"2018-02-22T00:00:00Z","timestamp":1519257600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2018,10]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n \n Patient\u2010reported outcomes (\n PRO<\/jats:styled-content>\n s) represent patients\u2019 perspective about their well\u2010being.\n <\/jats:p>\n <\/jats:sec>\n \n Aim<\/jats:title>\n \n To assess\n PRO<\/jats:styled-content>\n changes in patients with non\u2010alcoholic steatohepatitis (\n NASH<\/jats:styled-content>\n ) after treatment with selonsertib (\n SEL<\/jats:styled-content>\n ) and to associate them with different biomarkers.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Patients with\n NASH<\/jats:styled-content>\n and stage 2\u20103 fibrosis received\n SEL<\/jats:styled-content>\n 6\u00a0mg or 18\u00a0mg orally\n QD<\/jats:styled-content>\n alone or in combination with simtuzumab (\n SIM<\/jats:styled-content>\n , 125\u00a0mg\n SC<\/jats:styled-content>\n weekly) or\n SIM<\/jats:styled-content>\n alone for 24\u00a0weeks. Biopsies were obtained at baseline and at treatment week 24.\n PRO<\/jats:styled-content>\n s were assessed using\n SF<\/jats:styled-content>\n \u201036,\n CLDQ<\/jats:styled-content>\n and\n WPAI<\/jats:styled-content>\n :\n SHP<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Seventy\u2010two patients with\n NASH<\/jats:styled-content>\n were included (54\u00a0\u00b1\u00a010\u00a0years, 31% male, 65% stage 3, 71% diabetes). Baseline physical health\u2010related\n PRO<\/jats:styled-content>\n scores were significantly lower than population norms (\n P<\/jats:italic>\n \u00a0<\u00a0.05). During treatment, there were no consistent differences in treatment\u2010emergent\n PRO<\/jats:styled-content>\n changes between different regimens (\n P<\/jats:italic>\n \u00a0>\u00a0.05). However,\n NASH<\/jats:styled-content>\n subjects who experienced \u22652 decrease in\n NAFLD<\/jats:styled-content>\n Activity Score or \u22651\u2010stage reduction in fibrosis showed significant improvements in their\n PRO<\/jats:styled-content>\n s (up to +15.5% of a\n PRO<\/jats:styled-content>\n range size,\n P<\/jats:italic>\n \u00a0<\u00a0.05). Additionally, improvements in\n PRO<\/jats:styled-content>\n s (up to +21.5%,\n P<\/jats:italic>\n \u00a0<\u00a0.05) were noted in patients with at least 50% relative reduction in collagen, while\n NASH<\/jats:styled-content>\n subjects with >17% increase in their collagen experienced\n PRO<\/jats:styled-content>\n worsening (up to \u221213.9%,\n P<\/jats:italic>\n \u00a0<\u00a0.05). Baseline serum\n CK<\/jats:styled-content>\n \u201018,\n IL<\/jats:styled-content>\n \u20106 and\n CRP<\/jats:styled-content>\n significantly correlated with\n PRO<\/jats:styled-content>\n s (rho from \u22120.24 to \u22120.38,\n P<\/jats:italic>\n \u00a0<\u00a0.05).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n A decrease in hepatic collagen is the most prominently associated with improvement of\n PRO<\/jats:styled-content>\n s in\n NASH<\/jats:styled-content>\n patients with F2\u2010F3 treated with\n SEL<\/jats:styled-content>\n . Furthermore, serum cytokines are associated with baseline\n PRO<\/jats:styled-content>\n s and with treatment\u2010emergent changes in\n PRO<\/jats:styled-content>\n s in patients with\n NASH<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/liv.13706","type":"journal-article","created":{"date-parts":[[2018,1,29]],"date-time":"2018-01-29T14:47:37Z","timestamp":1517237257000},"page":"1849-1859","source":"Crossref","is-referenced-by-count":80,"title":["Improvement of hepatic fibrosis and patient\u2010reported outcomes in non\u2010alcoholic steatohepatitis treated with selonsertib"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9313-577X","authenticated-orcid":false,"given":"Zobair M.","family":"Younossi","sequence":"first","affiliation":[{"name":"Department of Medicine Center for Liver Diseases Inova Fairfax Hospital Falls Church VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Stepanova","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research in Liver Diseases Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Lawitz","sequence":"additional","affiliation":[{"name":"Texas Liver Institute San Antonio TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Charlton","sequence":"additional","affiliation":[{"name":"Intermountain Medical Center Salt Lake City UT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit","family":"Loomba","sequence":"additional","affiliation":[{"name":"University of California San Diego La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert P.","family":"Myers","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mani","family":"Subramanian","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John G.","family":"McHutchison","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary","family":"Goodman","sequence":"additional","affiliation":[{"name":"Betty and Guy Beatty Center for Integrated Research Inova Health System Falls Church VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,2,22]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29367"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28431"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2011.04724.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep4.1054"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29085"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.04.043"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27368"},{"key":"e_1_2_8_9_1","first-page":"756","article-title":"Nonalcoholic Steatohepatitis and Endpoints in Clinical Trials","volume":"12","author":"Hannah WN","year":"2016","journal-title":"Gastroenterol Hepatol (N Y)"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2016.02.012"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40273-015-0316-5"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2013-004318"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28785"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12955-016-0420-z"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgast-2016-000106"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2007.03426.x"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29514"},{"key":"e_1_2_8_18_1","unstructured":"Gilead Sciences.Safety Tolerability and Efficacy of GS\u20104997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2\u2010F3.https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02466516. 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