{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T09:22:05Z","timestamp":1774084925090,"version":"3.50.1"},"reference-count":34,"publisher":"American Society for Microbiology","issue":"2","license":[{"start":{"date-parts":[[2015,2,1]],"date-time":"2015-02-01T00:00:00Z","timestamp":1422748800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Patients with advanced hepatic fibrosis or cirrhosis with chronic hepatitis C virus (HCV) infection represent an unmet need. The HCV NS3\/4A inhibitor, faldaprevir, was evaluated in combination with the nonnucleoside NS5B inhibitor, deleobuvir, with or without ribavirin in treatment-naive patients with HCV genotype 1 infection in the SOUND-C2 study. Here, the efficacy and safety of this interferon-free regimen in a subset of patients with advanced liver fibrosis, including those with compensated cirrhosis, were assessed. Patients (\n                    <jats:italic>n<\/jats:italic>\n                    = 362) were randomized to once-daily faldaprevir with either twice-daily (BID) or three-times-daily (TID) deleobuvir for 16 (TID16W), 28 (TID28W and BID28W), or 40 (TID40W) weeks with or without ribavirin (TID28W-NR). Patients were classified according to fibrosis stage (F0 to F2 versus F3 to F4) and the presence of cirrhosis (yes\/no). In total, 85 (24%) patients had advanced fibrosis\/cirrhosis (F3 to F4) and 33 (9%) had cirrhosis. Within each treatment arm, differences in rates of sustained virologic response 12 weeks after completion of treatment (SVR12) between patients with mild to moderate fibrosis (F0 to F2) versus F3 to F4 did not show a consistent pattern and were not statistically significant (63% versus 47% for TID16W, 53% versus 76% for TID28W, 48% versus 67% for TID40W, 70% versus 67% for BID28W, and 40% versus 36% for TID28W-NR, respectively;\n                    <jats:italic>P<\/jats:italic>\n                    &gt; 0.05 for each arm). The most frequent adverse events in patients with\/without cirrhosis were gastrointestinal and skin events, which were mostly mild or moderate in intensity. The degree of liver fibrosis did not appear to affect the probability of achieving SVR12 following treatment with the interferon-free regimen of faldaprevir, deleobuvir, and ribavirin. (This study has been registered at ClinicalTrials.gov under registration no. NCT01132313.)\n                  <\/jats:p>","DOI":"10.1128\/aac.04383-14","type":"journal-article","created":{"date-parts":[[2014,12,15]],"date-time":"2014-12-15T22:19:23Z","timestamp":1418681963000},"page":"1282-1291","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis"],"prefix":"10.1128","volume":"59","author":[{"given":"Stefan","family":"Zeuzem","sequence":"first","affiliation":[{"name":"J. W. Goethe University Hospital, Frankfurt, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicente","family":"Soriano","sequence":"additional","affiliation":[{"name":"Hospital Carlos III, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tarik","family":"Asselah","sequence":"additional","affiliation":[{"name":"Service d'H\u00e9patologie, H\u00f4pital Beaujon, INSERM UMR S 1149, CRI, Universit\u00e9 Paris Diderot, DHU UNITY, Clichy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward J.","family":"Gane","sequence":"additional","affiliation":[{"name":"Auckland Clinical Studies, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Pierre","family":"Bronowicki","sequence":"additional","affiliation":[{"name":"INSERM 954, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Angus","sequence":"additional","affiliation":[{"name":"Austin Health, Heidelberg, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ansgar W.","family":"Lohse","sequence":"additional","affiliation":[{"name":"University Hospital Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felix","family":"Stickel","sequence":"additional","affiliation":[{"name":"University of Bern, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beat","family":"M\u00fcllhaupt","sequence":"additional","affiliation":[{"name":"University Hospital of Zurich, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart","family":"Roberts","sequence":"additional","affiliation":[{"name":"Alfred Hospital, Melbourne, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcus","family":"Schuchmann","sequence":"additional","affiliation":[{"name":"University Hospital Mainz, Mainz, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Manns","sequence":"additional","affiliation":[{"name":"Medical School of Hannover, Hannover, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Bourli\u00e8re","sequence":"additional","affiliation":[{"name":"H\u00f4pital Saint Joseph, Marseille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Buti","sequence":"additional","affiliation":[{"name":"Hospital Universitario Valle Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry O.","family":"Stern","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John-Paul","family":"Gallivan","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG, Ingelheim, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Voss","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG, Ingelheim, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John P.","family":"Sabo","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wulf","family":"B\u00f6cher","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG, Ingelheim, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Federico J.","family":"Mensa","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1478-3231.2011.02703.x"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24641"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2010.04370.x"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24370"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/lt.22072"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03620.x"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21492"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23340"},{"key":"e_1_3_3_10_2","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1177\/135965350901400415","article-title":"The pattern of pegylated interferon-alpha2b and ribavirin treatment failure in cirrhotic patients depends on hepatitis C virus genotype","volume":"14","author":"Aghemo A","year":"2009","unstructured":"Aghemo A, Rumi MG, Monico S, Prati GM, D'Ambrosio R, Donato MF, Colombo M. 2009. The pattern of pegylated interferon-alpha2b and ribavirin treatment failure in cirrhotic patients depends on hepatitis C virus genotype. Antivir Ther 14:577\u2013584.","journal-title":"Antivir Ther"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22759"},{"key":"e_1_3_3_12_2","volume-title":"Incivek (telaprevir) prescribing information","author":"Vertex Pharmaceuticals Inc","year":"2013","unstructured":"Vertex Pharmaceuticals Inc. 2013. Incivek (telaprevir) prescribing information. Vertex Pharmaceuticals Inc., Cambridge, MA. http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2013\/201917s012lbl.pdf. Accessed 15 July 2014."},{"key":"e_1_3_3_13_2","volume-title":"Victrelis (boceprevir) prescribing information","author":"Merck & Co., Inc","year":"2014","unstructured":"Merck & Co., Inc. 2014. Victrelis (boceprevir) prescribing information. Merck Sharp & Dohme Corp., Whitehouse Station, NJ. http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/202258s014lbl.pdf. 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Efficacy and safety of telaprevir-based regimens in cirrhotic patients with HCV genotype 1 and prior peginterferon\/ribavirin treatment failure: subanalysis of the REALIZE phase 3 study, abstr 31. Hepatology 54(Suppl 1) :374A\u2013375A.","journal-title":"Hepatology"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2013.04.035"},{"key":"e_1_3_3_20_2","volume-title":"Olysio (simeprevir) prescribing information","author":"Janssen Therapeutics","year":"2013","unstructured":"Janssen Therapeutics. 2013. Olysio (simeprevir) prescribing information. Janssen Therapeutics, Titusville, NJ. http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2013\/205123s001lbl.pdf. Accessed 15 July 2014."},{"key":"e_1_3_3_21_2","volume-title":"Sovaldi (sofosbuvir) prescribing information","author":"Gilead Sciences Inc","year":"2013","unstructured":"Gilead Sciences Inc. 2013. Sovaldi (sofosbuvir) prescribing information. 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