{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T04:50:44Z","timestamp":1791175844933,"version":"4.1.0"},"reference-count":47,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2015,9,1]],"date-time":"2015-09-01T00:00:00Z","timestamp":1441065600000},"content-version":"tdm","delay-in-days":167,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","award":["Abc"],"award-info":[{"award-number":["Abc"]}],"id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2015,6]]},"abstract":"<jats:p>Treatment with interferon (IFN) and ribavirin (RBV) significantly impairs quality of life and other patient\u2010reported outcomes (PROs). Patient experience with IFN\u2010 and RBV\u2010free anti\u2010HCV (hepatitis C virus) regimens has not been reported. We assessed PROs in patients treated with ledipasvir and sofosbuvir (LDV\/SOF) with and without RBV. Four different PRO questionnaires were administered at baseline, during, and post\u2010treatment in HCV genotype 1 patients treated with LDV\/SOF\u00b1RBV (ION\u20101, \u20102, and \u20103). A total of 1,952 patients were enrolled to be treated for 8 (N\u2009=\u2009431), 12 (N\u2009=\u2009867), or 24 weeks (N\u2009=\u2009654) with LDV\/SOF (N\u2009=\u20091,080) or LDV\/SOF+RBV (N\u2009=\u2009872). Baseline demographics and psychiatric disorders were similar between treatment groups (all <jats:italic toggle=\"yes\">P<\/jats:italic>\u2009&gt;\u20090.05). Patients receiving LDV\/SOF regimens showed significant improvement of PRO scores during treatment (up to +7.4%, +7.0%, and +6.7% on a normalized 0%\u2010100% scale in the 8\u2010, 12\u2010, and 24\u2010week\u2010long treatment groups, respectively (all <jats:italic toggle=\"yes\">P<\/jats:italic>\u2009&lt;\u20090.0001). These PRO improvements coincided with early viral suppression after 2 weeks of treatment and maximized by the end of treatment. On the other hand, during treatment with LDV\/SOF+RBV, PRO scores declined (up to \u22125.5% regardless of treatment duration; <jats:italic toggle=\"yes\">P<\/jats:italic>\u2009&lt;\u20090.0001). Receiving RBV was an independent predictor of PRO impairment in multivariate analysis (beta up to \u22125.9%; <jats:italic toggle=\"yes\">P<\/jats:italic>\u2009&lt;\u20090.0001). Patients who achieved sustained virological response at 12 weeks showed significant improvement of their PROs post\u2010treatment (up to +8.3%; <jats:italic toggle=\"yes\">P<\/jats:italic>\u2009&lt;\u20090.0001). <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>: IFN\u2010 and RBV\u2010free regimens with LDV\/SOF result in early HCV suppression with simultaneous improvement in PROs that continued throughout the duration of treatment and post\u2010treatment. (H<jats:sc>epatology<\/jats:sc> 2015;61:1798\u20101808)<\/jats:p>","DOI":"10.1002\/hep.27724","type":"journal-article","created":{"date-parts":[[2015,1,27]],"date-time":"2015-01-27T23:05:31Z","timestamp":1422399931000},"page":"1798-1808","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":125,"title":["Treatment with ledipasvir and sofosbuvir improves patient\u2010reported outcomes: Results from the ION\u20101, \u20102, and \u20103 clinical trials"],"prefix":"10.1097","volume":"61","author":[{"given":"Zobair M.","family":"Younossi","sequence":"first","affiliation":[{"name":"Center for Liver Diseases, Department of Medicine,Inova Fairfax Hospital,Falls Church,VA"},{"name":"Betty and Guy Beatty Center for Integrated Research,Inova Health System,Falls Church,VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Stepanova","sequence":"additional","affiliation":[{"name":"CLDQ LLC,Washington,DC"},{"name":"Betty and Guy Beatty Center for Integrated Research,Inova Health System,Falls Church,VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Marcellin","sequence":"additional","affiliation":[{"name":"Viral Hepatitis Research Unit in H\u00f4pital Beaujon,Clichy,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nezam","family":"Afdhal","sequence":"additional","affiliation":[{"name":"Hepatology, Beth Israel Deaconess Medical Center,Boston,MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kris V.","family":"Kowdley","sequence":"additional","affiliation":[{"name":"Liver Care Network and Organ Care Research,Swedish Medical Center,Seattle,WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Zeuzem","sequence":"additional","affiliation":[{"name":"Department of Medicine,J.W. Goethe University Hospital,Frankfurt,Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon L.","family":"Hunt","sequence":"additional","affiliation":[{"name":"Betty and Guy Beatty Center for Integrated Research,Inova Health System,Falls Church,VA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2015,3,18]]},"reference":[{"key":"hep27724-bib-0001-20241017","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1186\/1471-2458-9-34","article-title":"HCV\u2010related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality","volume":"9","year":"2009","journal-title":"BMC Public Health"},{"key":"hep27724-bib-0002-20241017","doi-asserted-by":"crossref","first-page":"1182","DOI":"10.1053\/j.gastro.2010.12.032","article-title":"Increasing prevalence of HCC and cirrhosis in patients with chronic hepatitis C virus 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