{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:01:40Z","timestamp":1792839700093,"version":"4.5.0"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T00:00:00Z","timestamp":1677715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"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":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>To evaluate the safety and tolerability of the fixed\u2010dose, single\u2010tablet regimen sofosbuvir\/velpatasvir (SOF\/VEL) for the treatment of hepatitis C virus (HCV) infection in three Phase 3 studies in patients with and without compensated cirrhosis. Data from three registrational trials (ASTRAL\u20101, NCT02201940; ASTRAL\u20102, NCT02220998; ASTRAL\u20103, NCT02201953) were pooled by treatment regimen. Researchers assessed treatment\u2010emergent adverse events (TEAEs) and laboratory abnormalities in patients randomized to SOF\/VEL or placebo for 12\u2009weeks in ASTRAL\u20101 and SOF\/VEL for 12\u2009weeks in ASTRAL\u20102 and ASTRAL\u20103. Overall, 1035 patients were treated with SOF\/VEL, and 116 patients received placebo. Rates of any TEAE were generally similar between patients receiving SOF\/VEL (79.4%) and those receiving placebo (76.7%). The majority of TEAEs were mild to moderate, with 23 (2.2%) treatment\u2010emergent serious AEs in patients treated with SOF\/VEL. Of these treatment\u2010emergent serious AEs, none led to premature study discontinuation, nor were they considered related to treatment. Presence of compensated cirrhosis, greater age and mild renal impairment did not impact incidence or severity of TEAEs with SOF\/VEL treatment. The most common TEAEs (incidence \u226510%) were headache, fatigue, nausea and nasopharyngitis in patients receiving SOF\/VEL; similar rates were observed in placebo\u2010treated patients. Three deaths (&lt;1%) were reported in patients treated with SOF\/VEL, all posttreatment and none assessed as related to study treatment. Similar to that of placebo, SOF\/VEL treatment of HCV infection had a safety\/tolerability profile that was not affected by baseline factors, such as the presence of compensated cirrhosis, mild renal impairment or advanced age.<\/jats:p>","DOI":"10.1111\/jvh.13814","type":"journal-article","created":{"date-parts":[[2023,2,6]],"date-time":"2023-02-06T07:03:45Z","timestamp":1675667025000},"page":"448-454","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["The tolerability of sofosbuvir\/velpatasvir for 12\u2009weeks in patients treated in the <scp>ASTRAL<\/scp> 1, 2 and 3 studies: A pooled safety analysis"],"prefix":"10.1111","volume":"30","author":[{"given":"Ira M.","family":"Jacobson","sequence":"first","affiliation":[{"name":"NYU Langone Health  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Bourgeois","sequence":"additional","affiliation":[{"name":"Campus Stuivenberg  Antwerp Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillipe","family":"Mathurin","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Lille, Universite Nord de France  Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Thuluvath","sequence":"additional","affiliation":[{"name":"Institute for Digestive Health and Liver Disease  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen D.","family":"Ryder","sequence":"additional","affiliation":[{"name":"NIHR Nottingham Biomedical Research Centre at Nottingham University Hospitals NHS Trust and The University of Nottingham, Queen's Medical Centre Campus  Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Gerken","sequence":"additional","affiliation":[{"name":"Helios Klinikum Niederberg  Velbert Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Candido","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Gilead Sciences Europe LTD  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Vanstraelen","sequence":"additional","affiliation":[{"name":"Gilead Sciences Europe LTD  Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Scherbakovsky","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anu","family":"Osinusi","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Tedesco","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham R.","family":"Foster","sequence":"additional","affiliation":[{"name":"Queen Mary University  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,3,2]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"World Health Organization. Hepatitis C.2021. Accessed November 11 2021.https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/hepatitis\u2010c."},{"key":"e_1_2_12_3_1","unstructured":"World Health Organization.Global health strategy on viral hepatitis 2016\u20132021.2016."},{"key":"e_1_2_12_4_1","volume-title":"Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection","author":"World Health Organization","year":"2018"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2017.1282459"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.14324"},{"key":"e_1_2_12_7_1","first-page":"1","article-title":"EASL recommendations on treatment of hepatitis C: final update of the series","volume":"73","author":"European Association for the Study of the Liver","year":"2020","journal-title":"J Hepatol"},{"key":"e_1_2_12_8_1","unstructured":"Call to action for liver associations to advance progress towards viral hepatits eliminiation: a focus on simplified approaches to HCV testing and cure.2019. Accessed January 26 2022.https:\/\/www.aasld.org\/programs\u2010initiatives\/viral\u2010hepatitis\u2010elimination\u2010call\u2010action."},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.7326\/M19-3860"},{"key":"e_1_2_12_10_1","unstructured":"Epclusa (sofosbuvir and velpatasvir) 400 mg\/100 mg film\u2010coated tablets. 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