{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T14:08:17Z","timestamp":1775830097772,"version":"3.50.1"},"reference-count":51,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,9,6]],"date-time":"2025-09-06T00:00:00Z","timestamp":1757116800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004423","name":"World Health Organization","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004423","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Sofosbuvir (SOF) plus daclatasvir (DCV) is a primary chronic hepatitis C virus (HCV) treatment in low\u2010 and middle\u2010income countries. WHO guidelines recommend a half\u2010adult dose for children (14\u201325\u2009kg) based on pharmacokinetic modelling, requiring clinical validation. We evaluated the pharmacokinetics, safety, efficacy and acceptability of DCV (30\u2009mg) and SOF (200\u2009mg) in children weighing 14 to &lt;\u200917\u2009kg and 17\u201335\u2009kg.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Children (3\u201313\u2009years; 14\u201335\u2009kg) with chronic HCV received a daily paediatric formulation of DCV 30\u2009mg and SOF 200\u2009mg for 12\u2009weeks. Intensive steady\u2010state PK sampling was performed. Efficacy was assessed by sustained virologic response at 12\u2009weeks post\u2010treatment (SVR12), and adverse events were monitored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Twenty\u2010three patients were enrolled in two groups: 14 to &lt;\u200917\u2009kg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200911; median age 5 [3\u20138] years) and 17\u201335\u2009kg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200912; median age 7 [5\u201313] years). For children 14 to &lt;\u200917\u2009kg, mean (CV%) AUC24 (ng\u00b7h\/mL) and\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>maxss<\/jats:sub>\n                      (ng\/mL) were 14\u2009875 (55) and 1604 (48) for DCV; 2683 (65) and 1562 (69) for SOF; and 10\u2009456 (77) and 1420 (84) for GS\u2010331007. For children 17\u201335\u2009kg, values were 11\u2009082 (47) and 1062 (32) for DCV; 2125 (88) and 952 (61) for SOF; and 15\u2009256 (27) and 1606 (46) for GS\u2010331007. All patients achieved SVR12, with good acceptability and no serious adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>For children 14\u201335\u2009kg with chronic HCV, half the adult dose of DCV (30\u2009mg) and SOF (200\u2009mg) offered comparable exposure, safety, efficacy and acceptability to the adult regimen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifier: NCT0585451\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/liv.70329","type":"journal-article","created":{"date-parts":[[2025,9,6]],"date-time":"2025-09-06T07:46:34Z","timestamp":1757144794000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in Young Children With Chronic\n                    <scp>HCV<\/scp>\n                    Infection"],"prefix":"10.1111","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9241-0127","authenticated-orcid":false,"given":"Ahmed N.","family":"Farrag","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy, Faculty of Pharmacy Cairo University  Cairo Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5956-8990","authenticated-orcid":false,"given":"Maggie M.","family":"Abbassi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Faculty of Pharmacy Cairo University  Cairo Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0478-0772","authenticated-orcid":false,"given":"Nirmeen A.","family":"Sabry","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Faculty of Pharmacy Cairo University  Cairo Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8106-0974","authenticated-orcid":false,"given":"Tim R.","family":"Cressey","sequence":"additional","affiliation":[{"name":"AMS\u2010Research Collaboration, Faculty of Associated Medical Sciences Chiang Mai University  Chiang Mai Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2603-5418","authenticated-orcid":false,"given":"Philipa","family":"Easterbrook","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Imperial College  London 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