{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T13:12:23Z","timestamp":1775567543543,"version":"3.50.1"},"reference-count":47,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,6,15]],"date-time":"2022-06-15T00:00:00Z","timestamp":1655251200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006093","name":"Patient-Centered Outcomes Research Institute","doi-asserted-by":"publisher","award":["HPC\u20101503\u201027891"],"award-info":[{"award-number":["HPC\u20101503\u201027891"]}],"id":[{"id":"10.13039\/100006093","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The PRIORITIZE trial (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">clinicaltrials.gov<\/jats:ext-link>: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir\/sofosbuvir (LDV\/SOF) and elbasvir\/grazoprevir (EBR\/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV\/SOF and EBR\/GZR on sustainable changes in several HCV\u2010associated symptoms and functional well\u2010being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS\u00ae symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhoea, abdominal pain) and functional well\u2010being using the disease\u2010specific HCV\u2010PRO instrument. Survey assessments were administered at baseline, early post\u2010treatment (median\u00a0=\u00a06\u00a0months) and late post\u2010treatment (median\u00a0=\u00a021\u2009months). Constrained longitudinal linear mixed\u2010effects models were used to evaluate within\u2010treatment change and between\u2010treatment differences. Data from 793 participants (average 55\u2009years old, 57% male, 44% black, 17% with cirrhosis) were analysed. From baseline to early post\u2010treatment, 5 out of 6 symptoms and functional well\u2010being significantly improved (all <jats:italic>p<\/jats:italic>'s\u2009&lt;\u2009.05). In the LDV\/SOF arm, mean changes ranged from \u22123.73 for nausea to \u22126.41 for fatigue and in the EBR\/GZR, mean changes ranged from \u22122.19 for cognitive impairment to \u22124.67 for fatigue. Change of &gt;3 points was consider clinically meaningful. Improvements in most symptoms slightly favoured LDV\/SOF, although the magnitude of differences between the regimens were small. Both regimens demonstrated significant improvements in symptoms and functional well\u2010being that were sustained during the late post\u2010treatment phase. EBR\/GZR and LDV\/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well\u2010being up to two years after SVR.<\/jats:p>","DOI":"10.1111\/jvh.13716","type":"journal-article","created":{"date-parts":[[2022,6,3]],"date-time":"2022-06-03T12:18:59Z","timestamp":1654258739000},"page":"795-806","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Sustainable and equivalent improvements in symptoms and functional <scp>well\u2010being<\/scp> following viral cure from ledipasvir\/sofosbuvir versus elbasvir\/grazoprevir for chronic hepatitis C\u00a0infection: Findings from the randomized <scp>PRIORITIZE<\/scp> trial"],"prefix":"10.1111","volume":"29","author":[{"given":"Donna M.","family":"Evon","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meichen","family":"Dong","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryce B.","family":"Reeve","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences Duke University School of Medicine  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joy","family":"Peter","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology &amp; Nutrition, Department of Medicine University of Florida  Gainesville Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Larry","family":"Michael","sequence":"additional","affiliation":[{"name":"Center for Gastroenterology Biology and Disease University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna S.","family":"Lok","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Internal Medicine University of Michigan  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David R.","family":"Nelson","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology &amp; Nutrition, Department of Medicine University of Florida  Gainesville Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul W.","family":"Stewart","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,6,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2005.08.016"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2010.08.026"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.039"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13365-018-0647-z"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11910-012-0311-6"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2011.01510.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2010.01339.x"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.23736\/S0026-4806.21.07388-2"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v21.i42.11974"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21072478"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31060"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1315722"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0785"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2013.11.032"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2019.04.016"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.13234"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.32053"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40271-016-0207-7"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2014.08.052"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40900-021-00249-2"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.04.011"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mlr.0000250483.85507.04"},{"key":"e_1_2_9_24_1","unstructured":"NIH PROMIS\u00ae Reference Populations. 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