{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T13:11:19Z","timestamp":1762866679323},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2016,2,25]],"date-time":"2016-02-25T00:00:00Z","timestamp":1456358400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"},{"start":{"date-parts":[[2016,2,25]],"date-time":"2016-02-25T00:00:00Z","timestamp":1456358400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver Transpl"],"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:p>Combination antiviral therapy involving sofosbuvir (SOF) and simeprevir (SIM) is a treatment option in patients with genotype 1 chronic hepatitis C; however, the safety of this regimen in patients with decompensated cirrhosis is not established. Data from a combined treatment cohort of 2 large hepatology referral centers were evaluated to assess for safety and efficacy of SIM plus SOF with or without ribavirin (RBV) in patients with Child B or C cirrhosis. All (n\u2009=\u200942) patients included in the analysis had Child B (n\u2009=\u200935) or C (n\u2009=\u20097) cirrhosis and received 400\u2009mg daily of SOF plus 150\u2009mg daily of SIM, with (n\u2009=\u20097) or without (n\u2009=\u200935) RBV, for 12 weeks. Of the 42 patients in this cohort, 31 (74%) were male, 22 (52%) had failed prior treatments, and 28 (67%) were genotype 1a. Prior decompensating events included encephalopathy (57%), fluid overload (88%), or variceal hemorrhage (24%). Median Model for End\u2010Stage Liver Disease score was 12 (range, 6\u201025). Treatment was well tolerated overall with more than one\u2010half (57%) reporting no adverse events. In those reporting adverse events, the most common were fatigue (n\u2009=\u20096), insomnia (n\u2009=\u20094), headache (n\u2009=\u20095), nausea (n\u2009=\u20094), and grade 1 rash (n\u2009=\u20091). One patient developed chemical pancreatitis that did not require treatment discontinuation. Three of 7 patients who received RBV developed anemia, with 2 requiring blood transfusions and 1 requiring a dose reduction. No episodes of decompensation requiring hospitalization or deaths occurred on treatment. Of 42 patients, 38 (90%) patients had negative viral load at end of treatment (EOT), and 31 of 42 patients (74%) achieved sustained virological response 12 weeks after EOT; 10 of 10 patients (100%) with HCV genotype 1b achieved sustained virological response for 12 weeks (SVR12). In conclusion, SOF plus SIM was very well tolerated in patients with advanced Child B\/C decompensated cirrhosis. Overall, 74% of patients achieved SVR12; 100% of patients with genotype 1b decompensated cirrhosis achieved SVR12. <jats:italic toggle=\"yes\">Liver Transpl 22:281\u2010286, 2016<\/jats:italic>. \u00a9 2015 AASLD.<\/jats:p>","DOI":"10.1002\/lt.24324","type":"journal-article","created":{"date-parts":[[2015,9,3]],"date-time":"2015-09-03T23:55:56Z","timestamp":1441324556000},"page":"281-286","source":"Crossref","is-referenced-by-count":26,"title":["Safety and efficacy of simeprevir plus sofosbuvir with or without ribavirin in patients with decompensated genotype 1 hepatitis C cirrhosis"],"prefix":"10.1097","volume":"22","author":[{"given":"Apurva A.","family":"Modi","sequence":"first","affiliation":[{"name":"Liver Consultants of Texas,Baylor Simmons Transplant Center,Fort Worth,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hector","family":"Nazario","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James F.","family":"Trotter","sequence":"additional","affiliation":[{"name":"Liver Consultants of Texas,Baylor Simmons Transplant Center,Fort Worth,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manjushree","family":"Gautam","sequence":"additional","affiliation":[{"name":"Liver Consultants of Texas,Baylor Simmons Transplant Center,Fort Worth,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Weinstein","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Parvez","family":"Mantry","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maisha","family":"Barnes","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adil","family":"Habib","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean","family":"McAfee","sequence":"additional","affiliation":[{"name":"Liver Consultants of Texas,Baylor Simmons Transplant Center,Fort Worth,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olga","family":"Teachenor","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"Tujague","sequence":"additional","affiliation":[{"name":"Liver Institute,Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stevan","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Liver 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