{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T23:23:21Z","timestamp":1782602601979,"version":"3.54.5"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,1,24]],"date-time":"2019-01-24T00:00:00Z","timestamp":1548288000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2019,1,24]],"date-time":"2019-01-24T00:00:00Z","timestamp":1548288000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>We reported the efficacy and safety data for daclatasvir (DCV)-based all-oral antiviral therapy in patients treated in the Italian compassionate-use program. 275 patients were included (202 male-73.5%, mean age: 57.4 years, 62 HIV-coinfected, 94 with recurrence of hepatitis C post-OLT). Forty-nine patients (17.8%) had Child-Pugh B, Genotype(G) distribution was: G1a:72 patients (26.2%), G1b:137 (49.8%); G3:40 (14.5%) and G4:26 (9.5%). Patients received DCV with sofosbuvir(SOF) (n\u2009=\u2009221, 129 with ribavirin(RBV) or with simeprevir (SMV) or asunaprevir (ASU) (n\u2009=\u200954, 19 with RBV) for up to 24 weeks. Logistic regression was used to identify baseline characteristics associated with sustained virological response at week 12 post-treatment (SVR12). Liver function changes between baseline and follow up were assessed in 228 patients. 240 patients achieved SVR12 (87.3%), post transplant and HIV co-infected patients were equally distributed among SVR and no SVR (35% vs 34.3%; p\u2009=\u20090.56 and 24.2% vs 11.4%, p\u2009=\u20090.13, respectively). SVR rate was significantly higher with the combination DCV\u2009+\u2009SOF compared with DCV\u2009+\u2009SIM or ASU (93.2% vs 63.0%, p\u2009&lt;\u20090.0001). Bilirubin value (OR: 0.69, CI95%: 0.54\u20130.87, p\u2009=\u20090.002) and regimen containing SOF (OR: 9.99, CI95%: 4.09\u201324.40; p\u2009&lt;\u20090.001) were independently related with SVR. Mean albumin and bilirubin values significantly improved between baseline and follow-up week 12. DCV-based antiviral therapy was well tolerated and resulted in a high SVR when combined with SOF either in pre-transplant and in OLT patients and in \u201cdifficult to treat\u201d HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.<\/jats:p>","DOI":"10.1038\/s41598-018-36734-0","type":"journal-article","created":{"date-parts":[[2019,1,24]],"date-time":"2019-01-24T11:04:17Z","timestamp":1548327857000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program"],"prefix":"10.1038","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0287-1059","authenticated-orcid":false,"given":"Vincenza","family":"Calvaruso","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Mazzarelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Milazzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Badia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luisa","family":"Pasulo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Guaraldi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaella","family":"Lionetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Villa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanni","family":"Borghi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Carrai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"Alberti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Biolato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Piai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcello","family":"Persico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4342-6904","authenticated-orcid":false,"given":"Teresa","family":"Santantonio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Felder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Angelico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzia","family":"Montalbano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6448-6279","authenticated-orcid":false,"given":"Rossella Letizia","family":"Mancusi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Grieco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Angeli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianpiero","family":"D\u2019Offizi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Fagiuoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Belli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Verucchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Puoti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Crax\u00ec","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,1,24]]},"reference":[{"key":"36734_CR1","doi-asserted-by":"publisher","first-page":"529","DOI":"10.1016\/j.jhep.2006.05.013","volume":"45","author":"JF Perz","year":"2006","unstructured":"Perz, J. F., Armstrong, G. L., Farrington, L. A., Hutin, Y. J. & Bell, B. P. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol 45, 529\u2013538 (2006).","journal-title":"J Hepatol"},{"key":"36734_CR2","doi-asserted-by":"publisher","first-page":"331","DOI":"10.1053\/jlts.2003.50073","volume":"9","author":"GL Davis","year":"2003","unstructured":"Davis, G. L., Albright, J. E., Cook, S. F. & Rosenberg, D. M. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 9, 331\u20138 (2003).","journal-title":"Liver Transpl."},{"key":"36734_CR3","doi-asserted-by":"crossref","unstructured":"Di Marco, V. et al. Effects of Viral Eradication in Patients With Hepatitis C Virus and Cirrhosis Differ With Stage of Portal Hypertension. 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Daclatasvir: potential role in hepatitis C. Drug Des Devel Ther. 7, 1223\u20131233 (2013).","journal-title":"Drug Des Devel Ther."},{"key":"36734_CR7","doi-asserted-by":"crossref","unstructured":"Nelson, D. R. et al. ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. Apr; 61(4), 1127\u201335 (2015)","DOI":"10.1002\/hep.27726"},{"key":"36734_CR8","doi-asserted-by":"publisher","first-page":"589","DOI":"10.1007\/s40264-016-0420-2","volume":"39","author":"EJ Smolders","year":"2016","unstructured":"Smolders, E. J. et al. Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and\/or Renal Impairment. Drug Saf. 39, 589\u2013611 (2016).","journal-title":"Drug Saf."},{"key":"36734_CR9","doi-asserted-by":"crossref","unstructured":"Kumada, H. et al. Daclatasvir Plus Asunaprevir for Chronic HCV Genotype 1b Infection. Hepatology. 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Daclatasvir and asunaprevir treatment in patients with severe liver fibrosis by hepatitis C virus genotype 1b infection: Real-world data. J Gastroenterol Hepatol. Nov; 32(11), 1879\u20131886 (2017)","DOI":"10.1111\/jgh.13779"},{"key":"36734_CR17","doi-asserted-by":"crossref","unstructured":"Welzel, T. M. et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. Nov; 65(11), 1861\u20131870 (2016)","DOI":"10.1136\/gutjnl-2016-312444"},{"key":"36734_CR18","doi-asserted-by":"crossref","unstructured":"Fourati, S. et al. Frequent antiviral treatment failures in patients infected with hepatitis C virus genotype 4, subtype 4r. Hepatology. 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The other authors declare no potential conflict of interest.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}],"article-number":"585"}}