{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T20:26:04Z","timestamp":1773951964212,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,2,6]],"date-time":"2018-02-06T00:00:00Z","timestamp":1517875200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>The phase 2, open\u2010label <jats:styled-content style=\"fixed-case\">ACCORDION<\/jats:styled-content> (ClinicalTrials.gov: <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>02349048) study investigated the efficacy, safety and pharmacokinetics of a 6\u2010 or 8\u2010week regimen of simeprevir, daclatasvir and sofosbuvir in treatment\u2010na\u00efve patients with chronic hepatitis C virus (<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>) genotype (<jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>) 1 infection and either early\u2010stage fibrosis or compensated cirrhosis. Patients were assigned to treatment groups according to their fibrosis stage. Early\u2010stage fibrosis: simeprevir 150\u00a0mg, daclatasvir 60\u00a0mg, sofosbuvir 400\u00a0mg once daily for 6\u00a0weeks; compensated cirrhosis: same regimen for 8\u00a0weeks. The primary endpoint was sustained virologic response 12\u00a0weeks after the end of treatment (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12). Safety, tolerability and pharmacokinetics of simeprevir, daclatasvir and sofosbuvir were investigated. Sixty\u2010eight patients were treated (6\u2010week group: n\u00a0=\u00a059; 8\u2010week group: n\u00a0=\u00a09). <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 was achieved by 86.4% (51\/59) of patients with early\u2010stage fibrosis and by 100% (9\/9) of patients with cirrhosis. The main reason for not achieving <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 in the 6\u2010week group was viral relapse (11.9%; 7\/59). One patient had on\u2010treatment failure due to an early withdrawal (lost to follow\u2010up due to incarceration). One patient with <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 in the 6\u2010week group had a late viral relapse at post\u2010treatment week 24. No clinically significant drug\u2010drug interactions were observed. Adverse events were reported in 63.2% of patients (43\/68) and were mainly grade 1\/2. None of these led to treatment discontinuation. The 3 direct\u2010acting antiviral regimens of simeprevir, daclatasvir and sofosbuvir were safe and well tolerated in treatment\u2010na\u00efve, <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content>1\u2010infected patients with early\u2010stage fibrosis or compensated cirrhosis.<\/jats:p>","DOI":"10.1111\/jvh.12853","type":"journal-article","created":{"date-parts":[[2017,12,24]],"date-time":"2017-12-24T10:37:56Z","timestamp":1514111876000},"page":"631-639","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy and safety of 6 or 8\u00a0weeks of simeprevir, daclatasvir, sofosbuvir for <scp>HCV<\/scp> genotype 1 infection"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2145-6352","authenticated-orcid":false,"given":"M. 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B.","family":"Smith","sequence":"additional","affiliation":[{"name":"NOCCR\/VRG University of Tennessee Medical Center  Knoxville TN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V.","family":"Van Eygen","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Luo","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceuticals, LLC  Titusville NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Vijgen","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Gamil","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. N.","family":"Kakuda","sequence":"additional","affiliation":[{"name":"Alios BioPharma, Inc. part of the Janssen Pharmaceutical Companies  South San Francisco CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Ouwerkerk\u2010Mahadevan","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Van Remoortere","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceuticals, LLC  Titusville NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Beumont","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,2,6]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Health Organization.Hepatitis C fact sheet.2017. 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