{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T17:48:28Z","timestamp":1793296108308,"version":"4.5.0"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T00:00:00Z","timestamp":1686182400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aims<\/jats:title><jats:p>The aim of this non\u2010commercial, open\u2010label, real\u2010life, non\u2010randomized clinical trial was to analyse the efficacy and safety of a pangenotypic regimen sofosbuvir\/velpatasvir (SOF\/VEL) in patients aged 6\u201318\u2009years with chronic hepatitis C virus (HCV) infection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Fifty patients qualified for the 12\u2010week treatment were divided into two weight groups: 15 children weighting between 17 and\u2009&lt;30\u2009kg received a fixed dose of 200\/50\u2009mg of SOF\/VEL (tablet) once daily, and 35 patients weighting \u226530\u2009kg were treated with 400\/100\u2009mg SOF\/VEL. The primary endpoint of the study was efficacy defined as sustained viral response (undetectable HCV RNA using an real\u2010time polymerase chain reaction method) at 12\u2009weeks posttreatment (SVR12).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Median age of the participants was 10 (IQR 8\u201312) years, 47 were infected vertically, and 3 patients were previously ineffectively treated with pegylated interferon and ribavirin. Thirty\u2010seven participants were infected with HCV genotype 1, 10 with HCV genotype 3 and the remaining 3 with genotype 4. There was no case of cirrhosis. SVR12 was 100%. Thirty\u2010three reported adverse events (AEs) were considered related to the administration of SOF\/VEL, all of them were mild or moderate. Children presenting with AEs were older compared to these without AEs: 12 (9.5\u201313) versus 9 (IQR 8\u201311) years (<jats:italic>p<\/jats:italic>\u2009=\u20090.008).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Results of the PANDAA\u2010PED study indicated a 100% effectiveness of a 12\u2010week therapy with SOF\/VEL in children aged 6\u201318\u2009years with chronic HCV infection and its good safety profile, in particular in younger patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.15637","type":"journal-article","created":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T10:29:58Z","timestamp":1686220198000},"page":"1871-1878","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Efficacy and safety of treatment with sofosbuvir\/velpatasvir in patients aged 6\u201318\u2009years with chronic hepatitis C\u2014Results of the <scp>PANDAA\u2010PED<\/scp> study"],"prefix":"10.1111","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7783-6904","authenticated-orcid":false,"given":"Maria","family":"Pokorska\u2010\u015apiewak","sequence":"first","affiliation":[{"name":"Department of Children's Infectious Diseases Medical University of Warsaw  Warsaw Poland"},{"name":"Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewa","family":"Talarek","sequence":"additional","affiliation":[{"name":"Department of Children's Infectious Diseases Medical University of Warsaw  Warsaw Poland"},{"name":"Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ma\u0142gorzata","family":"Aniszewska","sequence":"additional","affiliation":[{"name":"Department of Children's Infectious Diseases Medical University of Warsaw  Warsaw Poland"},{"name":"Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Pluta","sequence":"additional","affiliation":[{"name":"Department of Children's Infectious Diseases Medical University of Warsaw  Warsaw Poland"},{"name":"Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Dobrzeniecka","sequence":"additional","affiliation":[{"name":"Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Marczy\u0144ska","sequence":"additional","affiliation":[{"name":"Department of Children's Infectious Diseases Medical University of Warsaw  Warsaw Poland"},{"name":"Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw  Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3830-9823","authenticated-orcid":false,"given":"Giuseppe","family":"Indolfi","sequence":"additional","affiliation":[{"name":"Department of Neurofarba Meyer Children's University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,6,8]]},"reference":[{"key":"e_1_2_12_2_1","volume-title":"Global Health Sector Strategies on, Respectively, HIV, Viral Hepatitis and Sexually Transmitted Infections for the Period 2022\u20132030","year":"2022"},{"key":"e_1_2_12_3_1","volume-title":"Updated Recommendations on Treatment of Adolescents and Children with Chronic HCV Infection: Policy Brief","year":"2022"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30385-1"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhepr.2021.100227"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1586\/14787210.2015.1070668"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2018.11.013"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0040-1708812"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30046-9"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512610"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512612"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512614"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix260"},{"key":"e_1_2_12_14_1","unstructured":"European Medicines Agency.Epclusa. 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