{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:54:32Z","timestamp":1753869272900,"version":"3.41.2"},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,2,22]],"date-time":"2020-02-22T00:00:00Z","timestamp":1582329600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Health Science Reports"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and aims<\/jats:title><jats:p>Direct\u2010acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection have resulted in high rates of sustained virologic response (SVR) following 8 to 24\u2009weeks of treatment. However, difficult\u2010to\u2010cure\/cirrhotic patients typically require a longer treatment duration and less is known regarding the long\u2010term durability of SVR or effect on liver disease progression; to assess this, the IMPACT study followed patients for a 3\u2010year period after end of treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The Phase II, open\u2010label, nonrandomized IMPACT study assessed the efficacy, safety, and pharmacokinetics of the combination of three DAAs (simeprevir, sofosbuvir, and daclatasvir) in HCV genotype 1\/4\u2010infected, treatment\u2010na\u00efve\/\u2010experienced cirrhotic patients with portal hypertension or decompensated liver disease. Patients from a single site in the United States were assigned to one of two groups by Child\u2013Pugh (CP) score: CP A, CP score less than 7 and evidence of portal hypertension; CP B, CP score of 7 to 9. All patients received simeprevir 150\u2009mg, daclatasvir 60\u2009mg, and sofosbuvir 400\u2009mg once\u2010daily for 12\u2009weeks between September 2014 and August 2015. All 40 patients included in the study (male, 63%; median age, 58.5\u2009years) achieved SVR 12 and 24\u2009weeks after end of treatment, and the combination was well tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>All patients who reached the 3\u2010year follow\u2010up timepoint maintained SVR (CP A, 15\/15; CP B, 18\/18). CP scores and Model for End\u2010stage Liver Disease scores remained relatively stable, and mean FibroScan and FibroTest scores declined. No new safety signals were identified.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In the IMPACT study, virologic response to simeprevir, sofosbuvir, and daclatasvir was durable over 3\u2009years (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link> number: NCT02262728).<\/jats:p><\/jats:sec>","DOI":"10.1002\/hsr2.145","type":"journal-article","created":{"date-parts":[[2020,2,22]],"date-time":"2020-02-22T22:40:43Z","timestamp":1582411243000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Simeprevir, daclatasvir, and sofosbuvir for hepatitis C virus\u2010infected patients: Long\u2010term follow\u2010up results from the open\u2010label, Phase II IMPACT study"],"prefix":"10.1002","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4234-224X","authenticated-orcid":false,"given":"Eric","family":"Lawitz","sequence":"first","affiliation":[{"name":"Texas Liver Institute University of Texas Health Science Center  San Antonio Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fred","family":"Poordad","sequence":"additional","affiliation":[{"name":"Texas Liver Institute University of Texas Health Science Center  San Antonio Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julio A.","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Transplant and HPB Institute St. Vincent Medical Center  Los Angeles California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Beumont","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Greet","family":"Beets","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann","family":"Vandevoorde","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pieter Van","family":"Remoortere","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development LLC  Titusville New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donghan","family":"Luo","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development LLC  Titusville New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4356-2199","authenticated-orcid":false,"given":"Leen","family":"Vijgen","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8804-1613","authenticated-orcid":false,"given":"Veerle Van","family":"Eygen","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohamed","family":"Gamil","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,2,22]]},"reference":[{"unstructured":"World Health Organization. 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