{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:45:24Z","timestamp":1786977924773,"version":"build-2736575974"},"reference-count":26,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2014,6,24]],"date-time":"2014-06-24T00:00:00Z","timestamp":1403568000000},"content-version":"vor","delay-in-days":0,"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":[[2014,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>\n                      This study evaluated the potential for a drug\u2013drug interaction between HCV direct\u2010acting antivirals sofosbuvir or ledipasvir and oral hormonal contraceptive (OC) norgestimate\/ethinyl estradiol (norgestimate 0.18\/0.215\/0.25 mg with ethinyl estradiol 25 \u03bcg). This was a 112\u2010day, open\u2010label, fixed\u2010sequence pharmacokinetic (PK) study in healthy female subjects that included a lead\u2010in cycle (OC only; N = 21), cycle 1 (OC only; N = 15), cycle 2 (OC + sofosbuvir; N = 15), and cycle 3 (OC + ledipasvir; N = 15). Administration of sofosbuvir with OC did not alter PK of norelgestromin (primary norgestimate metabolite) or ethinyl estradiol. Small increases in norgestrel (secondary norgestimate metabolite) AUC\n                      <jats:sub>tau<\/jats:sub>\n                      (19%) and C\n                      <jats:sub>tau<\/jats:sub>\n                      (23%) with sofosbuvir were noted. Ledipasvir did not impact PK of norelgestromin or norgestrel but modestly increased ethinyl estradiol C\n                      <jats:sub>max<\/jats:sub>\n                      (40%). Sofosbuvir, GS\u2010 331007 (predominant circulating metabolite of SOF), and ledipasvir PK were similar to historical data. Pharmacodynamic markers luteinizing hormone, follicle\u2010stimulating hormone, and progesterone values were generally comparable in all cycles. No loss in contraceptive efficacy is expected upon administration of sofosbuvir or ledipasvir\/sofosbuvir with oral contraceptives containing norgestimate and ethinyl estradiol. The use of sofosbuvir or ledipasvir\/sofosbuvir FDC with oral contraceptives is permitted.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcph.346","type":"journal-article","created":{"date-parts":[[2014,6,13]],"date-time":"2014-06-13T07:11:59Z","timestamp":1402643519000},"page":"1290-1298","source":"Crossref","is-referenced-by-count":22,"title":["Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate\/ethinyl estradiol in HCV\u2010Uninfected female subjects"],"prefix":"10.1002","volume":"54","author":[{"given":"P.","family":"German","sequence":"first","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Moorehead","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillip","family":"Pang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Vimal","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Mathias","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,6,24]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"SOVALDI\u00ae (sofosbuvir) tablets for oral use. US Prescribing Information. Gilead Sciences Inc. Foster City CA. December 2013."},{"key":"e_1_2_6_3_1","unstructured":"REBETOL\u00ae (ribavirin USP) Capsules and Oral Solution. US Prescribing Information. 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(Accessed April 29 2010 athttp:\/\/www.niaid.nih.gov\/LabsAndResources\/resources\/DAIDSClinRsrch\/Documents\/daidsaegradingtable.pdf)."},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2007.03084.x"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.3851\/IMP1724"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2003.02015.x"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e3181eb5ff5"},{"key":"e_1_2_6_17_1","unstructured":"INTELENCE\u00ae (etravirine) tablets for oral use. US Prescribing Information. Janssen Pharmaceuticals Inc. 2008 Titusville NJ. 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