{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T12:02:23Z","timestamp":1778155343337,"version":"3.51.4"},"reference-count":17,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2017,5,12]],"date-time":"2017-05-12T00:00:00Z","timestamp":1494547200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4\/5 (CKD 4\/5). The aim of this analysis was to evaluate the impact of elbasvir\/grazoprevir (EBR\/GZR) on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II\/III clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We undertook a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR\/GZR phase II\/III clinical trials. All patients were required to have chronic HCV infection and have received EBR 50\u00a0mg\/GZR 100\u00a0mg, with or without ribavirin, for 8\u201318\u00a0weeks. Patients with CKD 3 (eGFR &lt;60 to \u226530\u00a0mL\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup>) at baseline plus \u22651 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12\u00a0weeks after completion of therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010two patients with CKD 3 were identified from a pooled dataset of 1689 patients enrolled in the EBR\/GZR clinical trial program. Thirty\u2010one (97%) patients achieved SVR12 and one patient relapsed. In these 32 patients, there was no decline in median eGFR at the end of treatment or at follow\u2010up week 12 compared with baseline. Median eGFR values were 56\u00a0mL\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup> (range, 45\u201359) at baseline, 58\u00a0mL\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup> (range, 41\u201378) at the end of treatment and 59\u00a0mL\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup> (range, 38\u201378) 12\u00a0weeks after completing treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Elbasvir\/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.12899","type":"journal-article","created":{"date-parts":[[2017,3,24]],"date-time":"2017-03-24T10:44:54Z","timestamp":1490352294000},"page":"1340-1345","source":"Crossref","is-referenced-by-count":21,"title":["Elbasvir\/grazoprevir does not worsen renal function in patients with hepatitis C virus infection and pre\u2010existing renal disease"],"prefix":"10.1111","volume":"47","author":[{"given":"K. Rajender","family":"Reddy","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Roth","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Hypertension University of Miami Miller School of Medicine  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annette","family":"Bruchfeld","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine Karolinska University Hospital, Karolinska Institute  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peggy","family":"Hwang","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Haber","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael N.","family":"Robertson","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eliav","family":"Barr","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wayne","family":"Greaves","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,5,12]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2012.01633.x"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2010.09.023"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.167.12.1271"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.12681"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(16)01602-0"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00349-9"},{"key":"e_1_2_6_8_1","first-page":"1137A","article-title":"Pharmacokinetics of co\u2010administered HCV protease inhibitor MK\u20105172 and NS5A Inhibitor MK\u20108742 in volunteers with end\u2010stage renal disease on hemodialysis or severe renal impairment not on hemodialysis","volume":"60","author":"Yeh WW","year":"2014","journal-title":"Hepatology"},{"key":"e_1_2_6_9_1","unstructured":"Merck Sharp & Dohme Corp.Zepatier [package insert].Whitehouse Station NJ: Merck Sharp & Dohme Corp. 2017."},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61795-5"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61793-1"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2015.04.009"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-016-1285-y"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0785"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(15)00114-9"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.09.045"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.2147\/IJNRD.S93887"},{"key":"e_1_2_6_18_1","first-page":"1","article-title":"KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease","volume":"3","author":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group","year":"2013","journal-title":"Kidney Int"}],"container-title":["Hepatology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhepr.12899","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.12899","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T10:05:43Z","timestamp":1696327543000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hepr.12899"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,5,12]]},"references-count":17,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2017,11]]}},"alternative-id":["10.1111\/hepr.12899"],"URL":"https:\/\/doi.org\/10.1111\/hepr.12899","archive":["Portico"],"relation":{},"ISSN":["1386-6346","1872-034X"],"issn-type":[{"value":"1386-6346","type":"print"},{"value":"1872-034X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,5,12]]}}}