{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T23:18:59Z","timestamp":1792624739649,"version":"4.5.0"},"reference-count":26,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T00:00:00Z","timestamp":1646092800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T00:00:00Z","timestamp":1646092800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background and Aims<\/jats:title>\n            <jats:p>Sofosbuvir\u2010velpatasvir\u2010voxilaprevir is a pangenotypic regimen for chronic HCV infection. In the USA and Europe, sofosbuvir\u2010velpatasvir\u2010voxilaprevir once daily for 12\u00a0weeks is indicated for adults who previously received an HCV NS5A inhibitor. In Europe, sofosbuvir\u2010velpatasvir\u2010voxilaprevir is also indicated in the absence of prior HCV direct\u2010acting antiviral (DAA) therapy as an 8\u2010week or 12\u2010week regimen. In an open\u2010label study, we evaluated the safety, efficacy, and pharmacokinetics of sofosbuvir\u2010velpatasvir\u2010voxilaprevir in adolescents 12 to 17\u00a0years with chronic HCV of any genotype.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>In this Phase 2, multicenter study, sofosbuvir\u2010velpatasvir\u2010voxilaprevir 400\/100\/100\u00a0mg daily was administered to adolescents for 8\u00a0weeks if DAA\u2010na\u00efve or for 12\u00a0weeks for cirrhosis or prior DAA failure. The key efficacy endpoint was sustained virologic response 12\u00a0weeks after therapy (SVR12). Intensive pharmacokinetic sampling was done in 14 patients at week 2 or 4, and samples for population pharmacokinetics were collected in all patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>All patients (<jats:italic toggle=\"yes\">n<\/jats:italic>\u00a0=\u00a021) were na\u00efve to HCV DAAs, and none had cirrhosis. HCV genotype 3a infection was most common, occurring in 43% of patients. Overall, 100% of patients (21 of 21) reached SVR12. The most common adverse events were abdominal pain and headache (24% each) and nausea (19%); no adverse events led to discontinuation. The only serious adverse event, hypotension, was considered related to study drug and resolved the same day without interruption of treatment. Sofosbuvir\u2010velpatasvir\u2010voxilaprevir exposures were similar to those observed in adults.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>The pangenotypic regimen of sofosbuvir\u2010velpatasvir\u2010voxilaprevir is highly efficacious and well\u2010tolerated in treating chronic HCV infection in adolescents.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1002\/hep.32393","type":"journal-article","created":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T03:58:42Z","timestamp":1643860722000},"page":"445-455","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":14,"title":["Sofosbuvir\u2010velpatasvir\u2010voxilaprevir in adolescents 12 to 17 years old with HCV infection"],"prefix":"10.1097","volume":"76","author":[{"given":"Guiseppe","family":"Indolfi","sequence":"first","affiliation":[{"name":"Department NEUROFARBA,Meyer Children\u2019s University Hospital,University of Florence,Florence,Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deirdre","family":"Kelly","sequence":"additional","affiliation":[{"name":"Birmingham Women\u2019s and Children\u2019s Hospital,University of Birmingham,Birmingham,UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Nebbia","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico,Milan,Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaele","family":"Iorio","sequence":"additional","affiliation":[{"name":"University of Naples Federico II,Naples,Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0141-2560","authenticated-orcid":false,"given":"Anna","family":"Mania","sequence":"additional","affiliation":[{"name":"Karol Marcinkowski University of Medical Sciences,Pozna\u0144,Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vania","family":"Giacomet","sequence":"additional","affiliation":[{"name":"Luigi Sacco Hospital,University of Milan,Milan,Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leszek","family":"Szenborn","sequence":"additional","affiliation":[{"name":"Medical University Wroc\u0142aw,Wroc\u0142aw,Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiang","family":"Shao","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc,Foster City,California,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mun","family":"Sang Yue","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc,Foster City,California,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chia\u2010Hsiang","family":"Hsueh","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc,Foster City,California,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bandita","family":"Parhy","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc,Foster City,California,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Kersey","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc,Foster City,California,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Mangia","sequence":"additional","affiliation":[{"name":"Ospedale Casa Sollievo della Sofferenza,San Giovanni Rotondo,Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malgorzata","family":"Pawlowska","sequence":"additional","affiliation":[{"name":"Collegium Medicum in Bydgoszcz Nicolaus Copernicus University in Toru\u0144,Toru\u0144,Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay","family":"Bansal","sequence":"additional","affiliation":[{"name":"King\u2019s College Hospital,London,UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2022,3,1]]},"reference":[{"key":"hep32393-bib-0001-20250824","doi-asserted-by":"crossref","first-page":"374","DOI":"10.1016\/S2468-1253(19)30385-1","article-title":"Global prevalence of hepatitis C virus in children in 2018: a modelling study","volume":"5","year":"2020","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"hep32393-bib-0002-20250824","doi-asserted-by":"crossref","first-page":"779","DOI":"10.1111\/j.1365-2893.2010.01381.x","article-title":"Hepatitis C virus infection among healthy Egyptian children: prevalence and risk factors","volume":"18","year":"2011","journal-title":"J Viral Hepat"},{"key":"hep32393-bib-0003-20250824","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.3748\/wjg.v22.i4.1382","article-title":"Vertically acquired hepatitis C virus infection: correlates of transmission and disease 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