{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,22]],"date-time":"2026-02-22T01:46:52Z","timestamp":1771724812088,"version":"3.50.1"},"reference-count":19,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":157,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2012,10]]},"abstract":"<jats:p><jats:bold>Background:<\/jats:bold>Telaprevir is a hepatitis C virus protease inhibitor that is both a substrate and an inhibitor of CYP3A. <jats:bold>Study Design:<\/jats:bold>The effect of steady\u2010state telaprevir (administered 750 mg every 8 hours) on the steady\u2010state pharmacokinetics of ethinyl estradiol (EE) and norethindrone (NE) was evaluated in 24 healthy women receiving oral contraceptives (OC) containing 0.5 mg NE and 0.035 mg EE for at least 3 months at the time of screening. This was a phase 1, open\u2010label, single\u2010center, nonrandomized study that included a cycle 1 (OC only for 21 days, followed by no OC for 7 days), cycle 2 (OC plus telaprevir for 21 days, followed by telaprevir alone for 7 days), and a follow\u2010up period. <jats:bold>Results:<\/jats:bold>When administration with or without telaprevir was compared, the least\u2010squares mean ratios (90% confidence limits) for EE were 0.74 (0.68; 0.80) for C<jats:sub>max<\/jats:sub>, 0.67 (0.63; 0.71) for C<jats:sub>min<\/jats:sub>, and 0.72 (0.69; 0.75) for AUC; neither NE nor telaprevir exposure was affected. <jats:bold>Conclusions:<\/jats:bold>The efficacy of the OC may be compromised by the 26% to 33% reduction in EE exposure. Therefore, alternative methods of nonhormonal contraception should be used when hormonal contraceptives are coadministered with telaprevir and for up to 2 weeks following cessation of telaprevir.<\/jats:p>","DOI":"10.1177\/0091270011419855","type":"journal-article","created":{"date-parts":[[2011,10,31]],"date-time":"2011-10-31T00:25:57Z","timestamp":1320020757000},"page":"1574-1583","source":"Crossref","is-referenced-by-count":25,"title":["The Pharmacokinetic Interaction Between an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone and the HCV Protease Inhibitor Telaprevir"],"prefix":"10.1002","volume":"52","author":[{"given":"Varun","family":"Garg","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rolf","family":"van Heeswijk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yijun","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Kauffman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frances","family":"Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathalie","family":"Adda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_5_2_2","doi-asserted-by":"publisher","DOI":"10.2174\/187152606776056706"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0807650"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0806104"},{"key":"e_1_2_5_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0908014"},{"issue":"4","key":"e_1_2_5_6_2","first-page":"427A","article-title":"Telaprevir in combination with peginterferon and ribavirin in genotype 1 HCV treatment\u2010na\u00efve patients: final results of phase 3 ADVANCE study","volume":"52","author":"Jacobson IM","year":"2010","journal-title":"Hepatology"},{"issue":"4","key":"e_1_2_5_7_2","first-page":"401A","article-title":"Telaprevir in combination with peginterferon alfa\u20102a and ribavirin for 24 or 48 weeks in treatment\u2010na\u00efve genotype 1 HCV patients who achieved an extended rapid viral response: final results of phase 3 ILLUMINATE study","volume":"52","author":"Sherman KE","year":"2010","journal-title":"Hepatology"},{"key":"e_1_2_5_8_2","first-page":"14","article-title":"Telaprevir\u2010based therapy in G1 HCV\u2010infected patients with prior null response, partial response or relapse to peginterferon\/ribavirin: REALIZE trial final results","volume":"5","author":"Foster G","year":"2011","journal-title":"Hepatol Int"},{"key":"e_1_2_5_9_2","volume-title":"Copegus (ribavirin USP) [medication guide]","year":"2005"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200746020-00003"},{"key":"e_1_2_5_11_2","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.104.000182"},{"key":"e_1_2_5_12_2","doi-asserted-by":"publisher","DOI":"10.1177\/009127009803801109"},{"key":"e_1_2_5_13_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.0306-5251.2001.01521.x"},{"key":"e_1_2_5_14_2","volume-title":"INCIVEK [prescribing information]"},{"key":"e_1_2_5_15_2","volume-title":"MODICON [medication guide]"},{"key":"e_1_2_5_16_2","volume-title":"Guidance for Industry. 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