{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:38:41Z","timestamp":1786977521398,"version":"build-2736575974"},"reference-count":27,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,3,12]],"date-time":"2019-03-12T00:00:00Z","timestamp":1552348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>A fixed\u2010dose combination of glecaprevir and pibrentasvir is approved for treatment of chronic infection with hepatitis C virus (HCV) genotypes 1\u20106. Three phase 1 open\u2010label studies were conducted in healthy volunteers to evaluate the potential for clinically relevant drug\u2010drug interactions of the glecaprevir 300\u2010mg and pibrentasvir 120\u2010mg combination with the immunosuppressants tacrolimus (1\u00a0mg) or cyclosporine (100 and 400\u00a0mg). Glecaprevir and pibrentasvir exposure was unaffected by tacrolimus, whereas the tacrolimus area under the curve (AUC) value was 45% higher with glecaprevir and pibrentasvir. Cyclosporine 100\u00a0mg had a limited effect on glecaprevir or pibrentasvir exposure (\u226437% AUC increase), but cyclosporine 400\u00a0mg increased exposure of both glecaprevir and pibrentasvir (410% and 93% AUC increase, respectively). Cyclosporine concentration was unaffected by glecaprevir and pibrentasvir at either cyclosporine dose (\u226414% AUC change). Adverse events were all grade 1 (mild), with the most common nausea and flushing attributed to cyclosporine. Findings from these studies supported evaluation of glecaprevir\/pibrentasvir in HCV\u2010infected kidney and liver transplant recipients receiving tacrolimus without additional dose adjustment or receiving cyclosporine up to 100\u00a0mg per day.<\/jats:p>","DOI":"10.1002\/cpdd.671","type":"journal-article","created":{"date-parts":[[2019,3,12]],"date-time":"2019-03-12T12:14:59Z","timestamp":1552392899000},"page":"779-789","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Drug\u2010Drug Interactions of Tacrolimus or Cyclosporine With Glecaprevir and Pibrentasvir in Healthy Subjects"],"prefix":"10.1002","volume":"8","author":[{"given":"Matthew P.","family":"Kosloski","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weihan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Data and Statistical Sciences AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Li","sequence":"additional","affiliation":[{"name":"Data and Statistical Sciences AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Pugatch","sequence":"additional","affiliation":[{"name":"Infectious Diseases AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armen","family":"Asatryan","sequence":"additional","affiliation":[{"name":"Infectious Diseases AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Kort","sequence":"additional","affiliation":[{"name":"Infectious Diseases AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico J.","family":"Mensa","sequence":"additional","affiliation":[{"name":"Infectious Diseases AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Liu","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,3,12]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2002.32418"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.12148"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02558-16"},{"issue":"1","key":"e_1_2_9_5_1","first-page":"e01620-e01617","article-title":"In vitro antiviral activity and resistance profile of the next\u2010generation hepatitis C virus NS3\/4A protease inhibitor glecaprevir","volume":"62","author":"Ng TI","year":"2018","journal-title":"Antimicrob Agents Chemother"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2017.09.027"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.07.020"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.03.039"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1702417"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(17)30496-6"},{"key":"e_1_2_9_11_1","article-title":"Glecaprevir\/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and\/or prior treatment experience: A partially randomized phase 3 clinical trial","author":"Wyles D","year":"2017","journal-title":"Hepatology"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1704053"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29081"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29671"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.13111"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2009.00430.x"},{"issue":"1","key":"e_1_2_9_17_1","article-title":"Drug\u2010drug interactions between next generation direct acting antivirals ABT\u2010493 and ABT\u2010530 with cyclosporine or tacrolimus in healthy subjects","volume":"62","author":"Kosloski M","year":"2015","journal-title":"Hepatology"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270006296523"},{"key":"e_1_2_9_19_1","doi-asserted-by":"crossref","first-page":"S405","DOI":"10.1016\/S0168-8278(16)00642-5","article-title":"ABT\u2010493 and ABT\u2010530 combination demonstrated minimal potential for CYP\u2010mediated drug\u2010drug interactions","volume":"64","author":"Kosloski MP","year":"2016","journal-title":"J Hepatol"},{"key":"e_1_2_9_20_1","unstructured":"KosloskiM ZhaoW LiH et\u00a0al.Drug\u2010drug interactions of glecaprevir and pibrentasvir with pravastatin rosuvastatin or dabigatran etexilate. 18th International Workshop on Clinical Pharmacology of Antiviral Therapy June 14\u201017 2017 Chicago IL. Abstract O\u201018.http:\/\/regist2.virology-education.com\/Abstractbook\/2017\/2017_5.pdf. 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