{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T11:58:09Z","timestamp":1773403089779,"version":"3.50.1"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2020,12,29]],"date-time":"2020-12-29T00:00:00Z","timestamp":1609200000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2020,12,29]],"date-time":"2020-12-29T00:00:00Z","timestamp":1609200000000},"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":["Liver Transpl."],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:p>Despite achieving sustained virologic response (SVR) to hepatitis C virus (HCV) therapy, there remains a post liver transplantation population with advanced fibrosis\/cirrhosis. Emricasan is an orally active, pan\u2010caspase inhibitor that suppresses apoptosis and inflammation, potentially decreasing hepatic inflammation and fibrosis. We aimed to determine the safety and efficacy of emricasan (IDN\u20106556\u201007) in a double\u2010blind, randomized, placebo\u2010controlled, multicenter study in reducing or preventing the progression of hepatic fibrosis in HCV liver transplant recipients with residual fibrosis or cirrhosis after achieving SVR. A total of 64 participants were randomly assigned to receive 25 mg twice daily of emricasan or placebo in a 2:1 ratio for 24 months. 41 participants were randomly assigned to emricasan and 23 to placebo; 32 participants in the emricasan group (78.0%) and 19 who took a placebo (82.6%) completed the study. There was no difference in the primary endpoint (Ishak fibrosis stages F2\u2010F5, improvement in fibrosis or stability; Ishak fibrosis stage F6, improvement) between the emricasan (77.1%) and placebo groups (74.1%); <jats:italic toggle=\"yes\">P<\/jats:italic> = NS. There was no difference between the emricasan (54.5%) and placebo (60.7%) arms in the rate of fibrosis improvement alone. However, those in the prespecified F3 to F5 subgroup had higher rates of stability or improvement in fibrosis in the emricasan group (95.2%) compared with placebo (54.6%) (<jats:italic toggle=\"yes\">P<\/jats:italic> = 0.01). The tolerability and safety profiles were similar in both groups. In conclusion, overall stability in the Ishak fibrosis stage was similar between emricasan and placebo groups at 24 months. However, there was improvement and\/or stability in fibrosis stage in the prespecified F3 to F5 subgroup with emricasan versus placebo, suggesting that patients with moderate fibrosis may benefit with emricasan.<\/jats:p>","DOI":"10.1002\/lt.25934","type":"journal-article","created":{"date-parts":[[2020,11,8]],"date-time":"2020-11-08T21:56:09Z","timestamp":1604872569000},"page":"568-579","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":16,"title":["Multicenter, Double\u2010Blind, Randomized Trial of Emricasan in Hepatitis C\u2013Treated Liver Transplant Recipients With Residual Fibrosis or Cirrhosis"],"prefix":"10.1097","volume":"27","author":[{"given":"Ethan M.","family":"Weinberg","sequence":"first","affiliation":[{"name":"Department of Medicine,University of Pennsylvania,Philadelphia,PA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael P.","family":"Curry","sequence":"additional","affiliation":[{"name":"Department of Medicine,Beth Israel Deaconess Medical Center,Boston,MA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2245-8173","authenticated-orcid":false,"given":"Catherine T.","family":"Frenette","sequence":"additional","affiliation":[{"name":"Center for Organ and Cell Transplantation,Scripps Clinic,La Jolla,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fredric G.","family":"Regenstein","sequence":"additional","affiliation":[{"name":"Department of Medicine,Tulane Medical Center,New Orleans,LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eugene R.","family":"Schiff","sequence":"additional","affiliation":[{"name":"Center for Liver Diseases,University of Miami,Miami,FL"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zachary D.","family":"Goodman","sequence":"additional","affiliation":[{"name":"Hepatic Pathology Consultation and Research,Inova Fairfax Hospital,Falls Church,VA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James M.","family":"Robinson","sequence":"additional","affiliation":[{"name":"Conatus Pharmaceuticals,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean L.","family":"Chan","sequence":"additional","affiliation":[{"name":"Conatus Pharmaceuticals,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne C.","family":"Imperial","sequence":"additional","affiliation":[{"name":"Conatus Pharmaceuticals,San Diego,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4898-7778","authenticated-orcid":false,"given":"K. 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