{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T03:09:30Z","timestamp":1788318570384,"version":"build-2803163510"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2018,1,20]],"date-time":"2018-01-20T00:00:00Z","timestamp":1516406400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Pharmacokinet"],"published-print":{"date-parts":[[2018,8]]},"DOI":"10.1007\/s40262-017-0624-3","type":"journal-article","created":{"date-parts":[[2018,1,20]],"date-time":"2018-01-20T01:49:05Z","timestamp":1516412945000},"page":"911-928","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Daclatasvir: A Review of Preclinical and Clinical Pharmacokinetics"],"prefix":"10.1007","volume":"57","author":[{"given":"Yash","family":"Gandhi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Eley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aberra","family":"Fura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenying","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard J.","family":"Bertz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8792-5513","authenticated-orcid":false,"given":"Tushar","family":"Garimella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2018,1,20]]},"reference":[{"key":"624_CR1","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1016\/S2468-1253(16)30181-9","volume":"2","author":"Polaris Observatory HCV Collaborators","year":"2017","unstructured":"Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:161\u201376.","journal-title":"Lancet Gastroenterol Hepatol."},{"issue":"5 Suppl. 1","key":"624_CR2","first-page":"S3","volume":"36","author":"National Institutes of Health","year":"2002","unstructured":"National Institutes of Health. National Institutes of Health Consensus Development Conference Statement: management of hepatitis C: June 10\u201312, 2002. Hepatology. 2002;36(5 Suppl. 1):S3\u201320.","journal-title":"Hepatology."},{"key":"624_CR3","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1097\/01.qco.0000136934.06039.01","volume":"17","author":"H Rodriguez-Luna","year":"2004","unstructured":"Rodriguez-Luna H, Douglas DD. Natural history of hepatitis C following liver transplantation. Curr Opin Infect Dis. 2004;17:363\u201371.","journal-title":"Curr Opin Infect Dis"},{"key":"624_CR4","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1046\/j.1365-2893.1999.6120139.x","volume":"6","author":"Global surveillance and control of hepatitis C","year":"1999","unstructured":"Global surveillance and control of hepatitis C. Report of a WHO consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat. 1999;6:35\u201347.","journal-title":"J Viral Hepat"},{"issue":"Suppl. 1","key":"624_CR5","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1159\/000048270","volume":"62","author":"H Yoshizawa","year":"2002","unstructured":"Yoshizawa H. Hepatocellular carcinoma associated with hepatitis C virus infection in Japan: projection to other countries in the foreseeable future. Oncology. 2002;62(Suppl. 1):8\u201317.","journal-title":"Oncology"},{"key":"624_CR6","doi-asserted-by":"publisher","first-page":"595","DOI":"10.1038\/nrd4050","volume":"12","author":"MP Manns","year":"2013","unstructured":"Manns MP, van Han T. Novel therapies for hepatitis C: one pill fits all? Nat Rev Drug Discov. 2013;12:595\u2013610.","journal-title":"Nat Rev Drug Discov"},{"key":"624_CR7","unstructured":"AASLD and IDSA. Recomendations for testing, managing and treatment hepatitis C November. 2016. \n                    http:\/\/www.hcvguidelines.org\n                    \n                  . Accessed 10 Nov 2016."},{"key":"624_CR8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.09.001","author":"European Association for the Study of the Liver (EASL)","year":"2016","unstructured":"European Association for the Study of the Liver (EASL). EASL recommendations on treatment of hepatitis C. J Hepatol. 2016. \n                    https:\/\/doi.org\/10.1016\/j.jhep.2016.09.001\n                    \n                   (In press).","journal-title":"J Hepatol"},{"key":"624_CR9","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1038\/nature08960","volume":"465","author":"M Gao","year":"2010","unstructured":"Gao M, Nettles R, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature. 2010;465:96\u2013100.","journal-title":"Nature"},{"key":"624_CR10","unstructured":"Daklinza (daclatasvir) Film-coated tablets: summary of product characteristics. Uxbridge, UK: Bristol-Myers Squibb Pharmaceutical Limited; 2016."},{"key":"624_CR11","unstructured":"Daclatasvir. Package insert. Princeton, New Jersey, USA: Bristol-Myers Squibb; 2017."},{"key":"624_CR12","unstructured":"Center for Drug Evaluation and Research. Clinical pharmacology and biopharmaceutics review(s). Daclatasvir. Application no. 20-6843. 2014."},{"key":"624_CR13","doi-asserted-by":"publisher","first-page":"809","DOI":"10.1124\/dmd.115.068866","volume":"44","author":"W Li","year":"2016","unstructured":"Li W, Zhao W, Liu X, et al. Biotransformation of daclatasvir in vitro and in nonclinical species: formation of the main metabolite by pyrrolidine d-oxidation and rearrangement. Drug Metab Dispos. 2016;44:809\u201320.","journal-title":"Drug Metab Dispos"},{"key":"624_CR14","first-page":"17","volume":"6","author":"M Bifano","year":"2013","unstructured":"Bifano M, Sevinsky H, Stonier M, Jiang H, Bertz RJ. Daclatasvir, an HCV NS5A replication complex inhibitor, has minimal effect on pharmacokinetics of midazolam, a sensitive probe for cytochrome P450 3A4. Rev Antivir Ther Infect Dis. 2013;6:17.","journal-title":"Rev Antivir Ther Infect Dis"},{"key":"624_CR15","unstructured":"Bifano M, Sevinsky H, Persson A, et al. Single-dose pharmacokinetics of daclatasvir (DCV; BMS-790052) in subjects with hepatic impairment compared with healthy subjects. In: Presented at the American Association for the Study of Liver Diseases; 5 Nov 2011; San Fransisco (CA)."},{"key":"624_CR16","doi-asserted-by":"publisher","first-page":"511","DOI":"10.3851\/IMP2718","volume":"19","author":"M Bifano","year":"2014","unstructured":"Bifano M, Sevinsky H, Hwang C, et al. Effect of the coadministration of daclatasvir on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate. Antivir Ther. 2014;19:511\u20139.","journal-title":"Antivir Ther"},{"key":"624_CR17","unstructured":"Bifano M, Connolly S, Hwang C, et al. The effect of co-administration of the proton-pump inhibitor omeprazole on the pharmacokinetics of daclatasvir in healthy subjects. In: Presented at the 48th Annual Meeting of the European Association for the Study of the Liver; 24\u201328 Apr 2013; Amsterdam."},{"key":"624_CR18","doi-asserted-by":"publisher","first-page":"931","DOI":"10.3851\/IMP2674","volume":"18","author":"M Bifano","year":"2013","unstructured":"Bifano M, Hwang C, Oosterhuis B, et al. Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir. Antivir Ther. 2013;18:931\u201340.","journal-title":"Antivir Ther"},{"key":"624_CR19","unstructured":"Bertz R. Bristol-Myers Squibb HCV full development portfolio overview. In: Plenary presentation presented at the 14th International Workshop on Clinical Pharmacology; 22\u201324 Apr 2014; Amsterdam."},{"issue":"5","key":"624_CR20","doi-asserted-by":"publisher","first-page":"535","DOI":"10.3851\/IMP2941","volume":"20","author":"T Garimella","year":"2015","unstructured":"Garimella T, Wang R, Luo W, et al. Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment. Antivir Ther. 2015;20(5):535\u201343.","journal-title":"Antivir Ther"},{"key":"624_CR21","doi-asserted-by":"publisher","first-page":"5503","DOI":"10.1128\/AAC.00478-15","volume":"59","author":"T Garimella","year":"2015","unstructured":"Garimella T, Wang R, Luo WL, et al. Assessment of drug\u2013drug interactions between daclatasvir and methadone or buprenorphine-naloxone. Antimicrob Agents Chemother. 2015;59:5503\u201310.","journal-title":"Antimicrob Agents Chemother"},{"key":"624_CR22","doi-asserted-by":"publisher","first-page":"281","DOI":"10.1007\/s40261-015-0279-5","volume":"35","author":"M Bifano","year":"2015","unstructured":"Bifano M, Adamczyk R, Hwang C, Kandoussi H, Marion A, Bertz RJ. An open-label investigation into drug\u2013drug interactions between multiple doses of daclatasvir and single-dose cyclosporine or tacrolimus in healthy subjects. Clin Drug Investig. 2015;35:281\u20139.","journal-title":"Clin Drug Investig"},{"key":"624_CR23","unstructured":"Gandhi Y, Adamczyk R, Wang R, et al. Assessment of drug\u2013drug interactions between daclatasvir and darunavir\/ritonavir or lopinavir\/ritonavir. In: Presented at the 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy; 26\u201328 May 2015; Washington, DC."},{"key":"624_CR24","unstructured":"Garimella T, Adamczyk R, Stonier M, et al. Effect of steady-state daclatasvir plus asunaprevir on the single-dose pharmacokinetics of the P-glycoprotein substrate digoxin in healthy adult subjects. Presented at ID Week 2014, 8\u201312 Oct 2014; Philadelphia (PA)."},{"key":"624_CR25","unstructured":"Janssen Therapeutics. Olysio\u2122 (simeprevir): summary of product characteristics. 2014. \n                    http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002777\/WC500167867.pdf\n                    \n                  . Accessed Jun 2016."},{"key":"624_CR26","first-page":"16","volume":"6","author":"T Eley","year":"2013","unstructured":"Eley T, You X, Huang S, et al. Evaluation of drug interaction potential between daclatasvir and sofosbuvir. Rev Antivir Ther Infect Dis. 2013;6:16.","journal-title":"Rev Antivir Ther Infect Dis"},{"issue":"10","key":"624_CR27","doi-asserted-by":"publisher","first-page":"1173","DOI":"10.1007\/s40262-016-0504-2","volume":"56","author":"P Chan","year":"2017","unstructured":"Chan P, Li H, Zhu L, et al. Population pharmacokinetic analysis of daclatasvir in subjects with chronic hepatitis C virus infection. Clin Pharmacokinet. 2017;56(10):1173\u201383.","journal-title":"Clin Pharmacokinet"},{"issue":"6","key":"624_CR28","doi-asserted-by":"publisher","first-page":"2083","DOI":"10.1002\/hep.27113","volume":"59","author":"H Kumada","year":"2014","unstructured":"Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014;59(6):2083\u201391.","journal-title":"Hepatology"},{"key":"624_CR29","doi-asserted-by":"publisher","first-page":"798","DOI":"10.1038\/nature08463","volume":"461","author":"DL Thomas","year":"2009","unstructured":"Thomas DL, Thio CL, Martin MP, et al. Genetic variation in IL28B and spontaneous clearance of hepatitis C virus. Nature. 2009;461:798\u2013801.","journal-title":"Nature"},{"key":"624_CR30","doi-asserted-by":"publisher","first-page":"1867","DOI":"10.1007\/s12325-016-0407-5","volume":"33","author":"T Garimella","year":"2016","unstructured":"Garimella T, You X, Wang R, et al. A review of daclatasvir drug\u2013drug interactions. Adv Ther. 2016;33:1867\u201384.","journal-title":"Adv Ther"},{"key":"624_CR31","unstructured":"Sovaldi (sofosbuvir). Package insert. Foster City, California, USA: Gilead Sciences Inc.; 2017."},{"key":"624_CR32","doi-asserted-by":"publisher","first-page":"677","DOI":"10.1007\/s40262-015-0261-7","volume":"54","author":"BJ Kirby","year":"2015","unstructured":"Kirby BJ, Symonds WT, Kearney BP, et al. Pharmacokinetic, pharmacodynamic, and drug-interaction profile of the hepatitis C virus NS5B polymerase inhibitor sofosbuvir. Clin Pharmacokinet. 2015;54:677\u201390.","journal-title":"Clin Pharmacokinet"},{"key":"624_CR33","doi-asserted-by":"publisher","first-page":"661","DOI":"10.1007\/s40261-014-0219-9","volume":"34","author":"T Eley","year":"2014","unstructured":"Eley T, Sevinsky H, Huang SP, He B, Zhu K, Kandoussi H, et al. The pharmacokinetics of daclatasvir and asunaprevir administered in combination in studies in healthy subjects and patients infected with hepatitis C virus. Clin Drug Investig. 2014;34:661\u201371.","journal-title":"Clin Drug Investig"},{"key":"624_CR34","doi-asserted-by":"publisher","first-page":"1205","DOI":"10.1007\/s40262-015-0299-6","volume":"54","author":"T Eley","year":"2015","unstructured":"Eley T, Garimella T, Li W, et al. Asunaprevir: a review of preclinical and clinical pharmacokinetics and drug-drug interactions. Clin Pharmacokinet. 2015;54:1205\u201322.","journal-title":"Clin Pharmacokinet"},{"key":"624_CR35","doi-asserted-by":"publisher","first-page":"159","DOI":"10.1002\/cpt.4","volume":"97","author":"T Eley","year":"2015","unstructured":"Eley T, Han Y-H, Huang S-P, He B, Li W, Bedford W, Stonier M, Gardiner D, Sims K, Rodrigues A, Bertz R. Organic anion transporting polypeptide-mediated transport of, and inhibition by, asunaprevir, an inhibitor of hepatitis C virus NS3 protease. Clin Pharmacol Ther. 2015;97:159\u201366.","journal-title":"Clin Pharmacol Ther"},{"key":"624_CR36","unstructured":"Gandhi Y, Adamczyk R, Wang R, et al. Assessment of drug\u2013drug interactions between daclatasvir and darunavir\/ritonavir or lopinavir\/ritonavir. In: Presented at the 16th international workshop on clinical pharmacology of HIV and hepatitis therapy 015; 26\u201328 May 2015, Washington, DC."},{"key":"624_CR37","doi-asserted-by":"publisher","first-page":"2225","DOI":"10.1111\/bcp.13323","volume":"83","author":"EJ Smolders","year":"2017","unstructured":"Smolders EJ, Colbers A, de Kanter CTMM, et al. Metformin and daclatasvir: absence of a pharmacokinetic\u2013pharmacodynamic drug interaction in healthy volunteers. Br J Clin Pharmacol. 2017;83:2225\u201334.","journal-title":"Br J Clin Pharmacol"}],"container-title":["Clinical Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40262-017-0624-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-017-0624-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-017-0624-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,1,19]],"date-time":"2019-01-19T20:34:07Z","timestamp":1547930047000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40262-017-0624-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1,20]]},"references-count":37,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2018,8]]}},"alternative-id":["624"],"URL":"https:\/\/doi.org\/10.1007\/s40262-017-0624-3","relation":{},"ISSN":["0312-5963","1179-1926"],"issn-type":[{"value":"0312-5963","type":"print"},{"value":"1179-1926","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1,20]]},"assertion":[{"value":"20 January 2018","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"All funding for preparation of this article was provided by Bristol-Myers Squibb and all the studies included were sponsored by Bristol-Myers Squibb.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Yash Gandhi, Aberra Fura, Wenying Li, and Tushar Garimella are current employees of Bristol-Myers Squibb and are shareholders. Richard Bertz and Timothy Eley were employees of Bristol-Myers Squibb at the time the studies were conducted and are shareholders.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}