{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T14:24:22Z","timestamp":1779114262747,"version":"3.51.4"},"reference-count":26,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,7,15]],"date-time":"2018-07-15T00:00:00Z","timestamp":1531612800000},"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2019,1]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>Clearance of chronic HCV<\/jats:styled-content> infection improves quality of life and other patient\u2010reported outcomes (PRO<\/jats:styled-content>s). Lack of placebo\u2010controlled data led to concerns about the extent of contribution of viral eradication to PRO<\/jats:styled-content> improvement.<\/jats:p><\/jats:sec>Aim<\/jats:title>To assess PRO<\/jats:styled-content> changes in HCV<\/jats:styled-content> patients initially randomized to placebo treatment who received SOF<\/jats:styled-content>\/VEL<\/jats:styled-content>\/VOX<\/jats:styled-content> in a deferred treatment substudy.<\/jats:p><\/jats:sec>Methods<\/jats:title>HCV<\/jats:styled-content>\u2010infected direct\u2010acting antivirals\u2010experienced patients who received placebo treatment in POLARIS<\/jats:styled-content>\u20101 subsequently received SOF<\/jats:styled-content>\/VEL<\/jats:styled-content>\/VOX<\/jats:styled-content> (400\/100\/100\u00a0mg) daily for 12\u00a0weeks. PRO<\/jats:styled-content>s were prospectively collected using SF<\/jats:styled-content>\u201036v2, CLDQ<\/jats:styled-content>\u2010HCV<\/jats:styled-content>, FACIT<\/jats:styled-content>\u2010F, WPAI<\/jats:styled-content>:SHP<\/jats:styled-content>.<\/jats:p><\/jats:sec>Results<\/jats:title>Of 147 patients treated, most were male (79%), white (82%), 33% had cirrhosis, 99% had HCV<\/jats:styled-content> genotype 1 with SVR<\/jats:styled-content>\u201012 of 97%. During treatment with placebo, there were no significant changes in any PRO<\/jats:styled-content>s from patients\u2019 own baseline (all P\u00a0<\/jats:italic>>\u00a0<\/jats:italic>.05) except for the Worry domain of CLDQ<\/jats:styled-content>\u2010HCV<\/jats:styled-content>. However, soon after initiation of treatment with SOF<\/jats:styled-content>\/VEL<\/jats:styled-content>\/VOX<\/jats:styled-content>, significant PRO<\/jats:styled-content> improvements were noted: +2.4% to +8.1% of a PRO<\/jats:styled-content> range size, P\u00a0<\/jats:italic><\u00a0<\/jats:italic>.05 for 6 of the 26 studied PRO<\/jats:styled-content>s, by treatment week 4; +2.0% to +8.3%, P\u00a0<\/jats:italic><\u00a0<\/jats:italic>.05 for 14\/26 PRO<\/jats:styled-content>s by treatment week 12. Achieving SVR<\/jats:styled-content> was associated with similar or greater PRO<\/jats:styled-content> improvement: +2.5% to +11.9%, P\u00a0<\/jats:italic><\u00a0<\/jats:italic>.05 for 24\/26 PRO<\/jats:styled-content>s, by SVR<\/jats:styled-content>\u201012; +3.2% to +14.9%, P\u00a0<\/jats:italic><\u00a0<\/jats:italic>.05 for 23\/26 PRO<\/jats:styled-content>s, by SVR<\/jats:styled-content>\u201024. In multivariate regression analysis, being viraemic was associated with PRO<\/jats:styled-content> impairment: beta from \u22122.4% to \u22128.5%, P\u00a0<\/jats:italic><\u00a0<\/jats:italic>.05 for all but one PRO<\/jats:styled-content>.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Treatment with SOF<\/jats:styled-content>\/VEL<\/jats:styled-content>\/VOX<\/jats:styled-content> for 12\u00a0weeks led to significant and sustainable improvement in patient\u2010reported outcomes in patients who had previously failed another direct\u2010acting antiviral regimen.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13900","type":"journal-article","created":{"date-parts":[[2018,6,12]],"date-time":"2018-06-12T09:31:41Z","timestamp":1528795901000},"page":"54-59","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Viral eradication is required for sustained improvement of patient\u2010reported outcomes in patients with hepatitis C"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9313-577X","authenticated-orcid":false,"given":"Zobair M.","family":"Younossi","sequence":"first","affiliation":[{"name":"Center for Liver Diseases Department of Medicine Inova Fairfax Hospital Falls Church VA USA"},{"name":"Betty and Guy Beatty Center for Integrated Research Inova Health System Falls Church VA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Stepanova","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research in Liver Diseases Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"University of Pennsylvania Philadelphia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael P.","family":"Manns","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Endocrinology Hannover Medical School Meintz Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Bourliere","sequence":"additional","affiliation":[{"name":"Department of Hepato\u2010Gastroenterology Hospital Saint Joseph Marseille France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart C.","family":"Gordon","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Henry Ford Hospital Detroit MI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eugene","family":"Schiff","sequence":"additional","affiliation":[{"name":"Schiff Center For Liver Diseases University of Miami Miami FL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tram","family":"Tran","sequence":"additional","affiliation":[{"name":"Liver Disease and Transplant Center Cedars\u2013Sinai Medical Center Los Angeles LA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Issah","family":"Younossi","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research in Liver Diseases Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrei","family":"Racila","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research in Liver Diseases Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,7,15]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"National Quality Forum.Patient\u2010Reported Outcomes in Performance Measurement. 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