{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,4]],"date-time":"2025-05-04T01:50:29Z","timestamp":1746323429096,"version":"3.27.0"},"reference-count":8,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2015,5,20]],"date-time":"2015-05-20T00:00:00Z","timestamp":1432080000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2015,5,20]],"date-time":"2015-05-20T00:00:00Z","timestamp":1432080000000},"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":[[2015,7]]},"abstract":"<jats:p>Retreatment of patients who have not achieved sustained virological response (SVR) after treatment with investigational direct\u2010acting antiviral agents (DAAs) has not been extensively studied. We conducted an open\u2010label trial to assess the efficacy and safety of sofosbuvir (SOF) plus pegylated interferon (Peg\u2010IFN) and ribavirin (RBV) in patients with genotype 1 hepatitis C virus (HCV) who participated in previous studies of one or more Gilead investigational DAAs in combination with RBV with or without Peg\u2010IFN. We enrolled 80 patients at 40 sites. All patients received SOF 400 mg once daily plus Peg\u2010IFN\u2010\u03b1 180 \u03bcg\/week and weight\u2010based ribavirin (1,000 or 1,200 mg\/day) for 12 weeks. The efficacy endpoint was the proportion of patients with SVR 12 weeks after discontinuation of therapy (SVR12). Of the 80 patients enrolled, 36 (45%) had received two or more courses of earlier treatment for HCV and 74 (93%) had at least one resistance\u2010associated variant (RAV) at baseline. SVR12 was achieved by 63 of the 80 patients (79%) treated. Rates of SVR12 were similar across patient subgroups. Presence of RAVs at baseline did not appear to be associated with treatment failure. Seventy\u2010one of eighty patients (89%) experienced at least one adverse event (AE), but most events were mild to moderate in severity. The most common AEs were fatigue, headache, and nausea. No patients discontinued all treatment because of AEs. <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>: These findings suggest that SOF plus Peg\u2010IFN and RBV for 12 weeks is effective and safe in patients who have not achieved SVR with earlier regimens of one or more DAAs plus Peg\u2010IFN and RBV. (H<jats:sc>epatology<\/jats:sc> 2015;62:129\u2010134)<\/jats:p>","DOI":"10.1002\/hep.27836","type":"journal-article","created":{"date-parts":[[2015,4,6]],"date-time":"2015-04-06T22:11:51Z","timestamp":1428358311000},"page":"129-134","update-policy":"http:\/\/dx.doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":21,"title":["Sofosbuvir plus pegylated interferon and ribavirin in patients with genotype 1 hepatitis C virus in whom previous therapy with direct\u2010acting antivirals has failed"],"prefix":"10.1097","volume":"62","author":[{"given":"Stanislas","family":"Pol","sequence":"first","affiliation":[{"name":"Universit\u00e9 Paris Descartes, H\u00f4pital Cochin, Inserm UMS20, Institut Pasteur,Paris,France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark S.","family":"Sulkowski","sequence":"additional","affiliation":[{"name":"John Hopkins University,Baltimore,MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tarek","family":"Hassanein","sequence":"additional","affiliation":[{"name":"Southern California Liver Center,Coronado,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward J.","family":"Gane","sequence":"additional","affiliation":[{"name":"Aukland City Hospital,Auckland,NZ"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Liu","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongmei","family":"Mo","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Doehle","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bittoo","family":"Kanwar","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana","family":"Brainard","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G. Mani","family":"Subramanian","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William T.","family":"Symonds","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John G.","family":"McHutchison","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald G.","family":"Nahass","sequence":"additional","affiliation":[{"name":"Infectious Disease Care,Hillsborough,NJ"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Bennett","sequence":"additional","affiliation":[{"name":"Medical Associates Research Group,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ira M.","family":"Jacobson","sequence":"additional","affiliation":[{"name":"Weill Cornell Medical College,New York,NY"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","published-online":{"date-parts":[[2015,5,20]]},"reference":[{"key":"hep27836-bib-0001-20241017","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1001\/jama.2014.7085","article-title":"Treatment of hepatitis C: a systematic review","volume":"312","year":"2014","journal-title":"JAMA"},{"key":"hep27836-bib-0002-20241017","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1002\/emmm.201303131","article-title":"Emerging therapies for the treatment of hepatitis C","volume":"6","year":"2014","journal-title":"EMBO Mol Med"},{"key":"hep27836-bib-0003-20241017","doi-asserted-by":"crossref","first-page":"1557","DOI":"10.1016\/S0140-6736(14)61225-3","article-title":"Hepatitis C beware\u2014the end is nigh","volume":"384","year":"2014","journal-title":"Lancet"},{"key":"hep27836-bib-0004-20241017","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1001\/jama.2014.7085","article-title":"Treatment of hepatitis C: a systematic review","volume":"312","year":"2014","journal-title":"JAMA"},{"key":"hep27836-bib-0005-20241017","first-page":"16","article-title":"Resistance to hepatitis C virus protease inhibitors","volume":"8C","year":"2014","journal-title":"Curr Opin Virol"},{"key":"hep27836-bib-0006-20241017","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/j.antiviral.2014.05.015","article-title":"Update on hepatitis C virus resistance to direct\u2010acting antiviral agents","volume":"108","year":"2014","journal-title":"Antiviral Res"},{"key":"hep27836-bib-0008-20241017","doi-asserted-by":"crossref","first-page":"1878","DOI":"10.1056\/NEJMoa1214853","article-title":"Sofosbuvir for previously untreated chronic hepatitis C infection","volume":"368","year":"2013","journal-title":"N Engl J Med"},{"key":"hep27836-bib-0009-20241017","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1002\/hep.27053","article-title":"All\u2010oral combination of ledipasvir, vedroprevir, tegobuvir, and ribavirin in treatment\u2010na\u00efve patients with genotype 1 HCV infection","volume":"60","year":"2014","journal-title":"Hepatology"}],"container-title":["Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhep.27836","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hep.27836","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/hep.27836","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.lww.com\/01515467-201507000-00019","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,18]],"date-time":"2024-10-18T00:28:41Z","timestamp":1729211321000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.lww.com\/01515467-201507000-00019"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,5,20]]},"references-count":8,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2015]]}},"URL":"https:\/\/doi.org\/10.1002\/hep.27836","relation":{},"ISSN":["0270-9139","1527-3350"],"issn-type":[{"type":"print","value":"0270-9139"},{"type":"electronic","value":"1527-3350"}],"subject":[],"published":{"date-parts":[[2015,5,20]]},"assertion":[{"value":"2014-12-17","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-04-03","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}