{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T08:49:49Z","timestamp":1777452589561,"version":"3.51.4"},"reference-count":33,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2013,7,1]],"date-time":"2013-07-01T00:00:00Z","timestamp":1372636800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2014,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Daclatasvir is a highly selective NS5A replication complex inhibitor currently in development for the treatment of chronic hepatitis C infection. Daclatasvir is active at picomolar concentrations and demonstrates in vitro activity against a broad range of HCV genotypes. The primary objective of this study was to assess the effect of daclatasvir on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate (Ortho Tri-Cyclen\u00ae).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this open-label single-sequence study, 20 healthy female subjects received ethinyl estradiol and norgestimate for three cycles, with coadministration of daclatasvir in cycle 3. Pharmacokinetics of ethinyl estradiol and the active metabolites of norgestimate (norelgestromin and norgestrel) were assessed in cycles 2 and 3.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Adjusted ratios of geometric means and 90% CIs were estimated for the maximum observed plasma concentration (ethinyl estradiol 1.11 [1.02, 1.20], norelgestromin 1.06 [0.99, 1.14] and norgestrel 1.07 [0.99, 1.16]) and area under the plasma concentration\u2013time curve in one dosing interval (ethinyl estradiol 1.01 [0.95, 1.07], norelgestromin 1.12 [1.06, 1.17] and norgestrel 1.12 [1.02, 1.23]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Coadministration of daclatasvir resulted in no clinically relevant effects on exposure to ethinyl estradiol, norelgestromin or norgestrel.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp2718","type":"journal-article","created":{"date-parts":[[2013,12,17]],"date-time":"2013-12-17T06:28:20Z","timestamp":1387261700000},"page":"511-519","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Effect of the Coadministration of Daclatasvir on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate"],"prefix":"10.1177","volume":"19","author":[{"given":"Marc","family":"Bifano","sequence":"first","affiliation":[{"name":"Research and Development, Bristol\u2013Myers Squibb, Hopewell, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Sevinsky","sequence":"additional","affiliation":[{"name":"Research and Development, Bristol\u2013Myers Squibb, Hopewell, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carey","family":"Hwang","sequence":"additional","affiliation":[{"name":"Research and Development, Bristol\u2013Myers Squibb, Princeton, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hamza","family":"Kandoussi","sequence":"additional","affiliation":[{"name":"Research and Development, Bristol\u2013Myers Squibb, Lawrenceville, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hao","family":"Jiang","sequence":"additional","affiliation":[{"name":"Research and Development, Bristol\u2013Myers Squibb, Lawrenceville, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dennis","family":"Grasela","sequence":"additional","affiliation":[{"name":"Research and Development, Bristol\u2013Myers Squibb, Hopewell, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Bertz","sequence":"additional","affiliation":[{"name":"Research 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(boceprevir).","year":"2012"},{"key":"bibr9-IMP2718","volume-title":"Package insert","author":"Incivek (telaprevir).","year":"2012"},{"key":"bibr10-IMP2718","doi-asserted-by":"publisher","DOI":"10.1016\/S1665-2681(19)31022-1"},{"key":"bibr11-IMP2718","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24443"},{"key":"bibr12-IMP2718","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600700416"},{"key":"bibr13-IMP2718","doi-asserted-by":"crossref","first-page":"500","DOI":"10.1016\/S0026-895X(25)13356-7","volume":"33","author":"Guengerich F.P.","year":"1988","journal-title":"Mol Pharmacol"},{"key":"bibr14-IMP2718","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.104.000182"},{"key":"bibr15-IMP2718","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1016\/S0026-895X(25)13456-1","volume":"43","author":"Ebner T.","year":"1993","journal-title":"Mol 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Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. (Accessed 8 June 2012). Available from http:\/\/aidsinfo.nih.gov\/guidelines."},{"key":"bibr25-IMP2718","doi-asserted-by":"publisher","DOI":"10.3851\/IMP1724"},{"key":"bibr26-IMP2718","doi-asserted-by":"crossref","first-page":"563","DOI":"10.1177\/135965350801300415","volume":"13","author":"Sekar V.J.","year":"2008","journal-title":"Antivir Ther"},{"key":"bibr27-IMP2718","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.212494599"},{"key":"bibr28-IMP2718","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.30.7.795"},{"key":"bibr29-IMP2718","doi-asserted-by":"publisher","DOI":"10.1345\/aph.17332"},{"key":"bibr30-IMP2718","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1111\/j.1528-1167.2010.02917.x","volume":"52","author":"Davis A.R.","year":"2011","journal-title":"Epilepsia"},{"key":"bibr31-IMP2718","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011419855"},{"key":"bibr32-IMP2718","unstructured":"Royal College of Obstetricians and Gynaecologists. 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