{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T08:57:03Z","timestamp":1777453023641,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2018,8,1]],"date-time":"2018-08-01T00:00:00Z","timestamp":1533081600000},"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":[[2019,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Doravirine (DOR) is a novel non-nucleoside reverse transcriptase inhibitor available as a single tablet and a three-drug combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) to treat HIV-1 infection. These analyses assessed pharmacokinetic (PK) interactions with coadministration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Two trials were conducted. Study 1: two-period, fixed-sequence; eight healthy participants; Period 1, DOR 100 mg followed by \u22657-day washout; Period 2, TDF 300 mg once daily for 18 days, coadministration of DOR 100 mg on day 14. Study 2: three-period, crossover, 15 healthy participants; Treatment A, DOR 100 mg; Treatment B, 3TC 300 mg + TDF 300 mg; Treatment C, DOR 100 mg + 3TC 300 mg + TDF 300 mg; \u22657-day washout between periods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Study 1: geometric mean ratios (GMRs; 90% confidence interval [CI]) of DOR area under the concentration\u2013time curve from time 0 extrapolated to infinity (AUC\n                      <jats:sub>0\u2013\u221e<\/jats:sub>\n                      ) and observed plasma concentrations at 24 h post-dose (C\n                      <jats:sub>24 h<\/jats:sub>\n                      ; DOR+TDF\/DOR) were 0.95 (0.80, 1.12) and 0.94 (0.78, 1.12), respectively. Study 2: GMRs (90% CI) of DOR AUC\n                      <jats:sub>0\u2013\u221e<\/jats:sub>\n                      and C\n                      <jats:sub>24 h<\/jats:sub>\n                      (DOR+3TC+TDF\/DOR) were 0.96 (0.87, 1.06) and 0.94 (0.83, 1.06), respectively. GMRs (90% CI) of 3TC and tenofovir AUC\n                      <jats:sub>0\u2013\u221e<\/jats:sub>\n                      (DOR+3TC+TDF\/3TC+TDF) were 0.94 (0.88, 1.00) and 1.11 (0.97, 1.28), respectively. Study drugs were generally well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Multiple doses of TDF did not have a clinically meaningful effect on DOR PK. The PK of DOR were similar when administered alone or in combination with 3TC and TDF. DOR had no meaningful effect on the PK of 3TC and tenofovir.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp3324","type":"journal-article","created":{"date-parts":[[2019,8,21]],"date-time":"2019-08-21T10:35:51Z","timestamp":1566383751000},"page":"443-450","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["No Meaningful Drug Interactions with Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate Coadministration"],"prefix":"10.1177","volume":"24","author":[{"given":"Matt S","family":"Anderson","sequence":"first","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"},{"name":"Present address: Certara USA, Inc., Princeton, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jocelyn","family":"Gilmartin","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Fan","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ka Lai","family":"Yee","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walter K","family":"Kraft","sequence":"additional","affiliation":[{"name":"Thomas Jefferson University, Philadelphia, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilias","family":"Triantafyllou","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christina","family":"Reitmann","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Guo","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachael","family":"Liu","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marian","family":"Iwamoto","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2018,8,1]]},"reference":[{"key":"bibr1-IMP3324","unstructured":"UNAIDS. Global HIV & AIDS Statistics - 2018 Fact Sheet. 2018. (Accessed 14 May 2019.) Available from http:\/\/www.unaids.org\/en\/resources\/fact-sheet"},{"key":"bibr2-IMP3324","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2018. (Accessed 14 May 2019.) Available from https:\/\/aidsinfo.nih.gov\/contentfiles\/lvguidelines\/adultandadolescentgl.pdf"},{"key":"bibr3-IMP3324","unstructured":"European AIDS Clinical Society. European guidelines for treatment of HIV-positive adults in Europe, version 9.1. 2018. (Accessed 14 May 2019.) Available from http:\/\/www.eacsociety.org\/files\/2018_guidelines-9.1-english.pdf"},{"key":"bibr4-IMP3324","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02403-13"},{"key":"bibr5-IMP3324","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(18)30021-3"},{"key":"bibr6-IMP3324","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy540"},{"key":"bibr7-IMP3324","unstructured":"Pifeltro (doravirine) prescribing information. Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. 2019. (Accessed 7 October 2019.) Available from https:\/\/www.merck.com\/product\/usa\/pi_circulars\/p\/pifeltro\/pifeltro_pi.pdf"},{"key":"bibr8-IMP3324","unstructured":"Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) prescribing information. Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. 2019. (Accessed 7 October 2019.) Available from https:\/\/www.merck.com\/product\/usa\/pi_circulars\/d\/delstrigo\/delstrigo_pi.pdf"},{"key":"bibr9-IMP3324","doi-asserted-by":"publisher","DOI":"10.1080\/00498254.2018.1451667"},{"key":"bibr10-IMP3324","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1103"},{"key":"bibr11-IMP3324","unstructured":"Anderson M.S., Chung C., Tetteh E. Effect of ketoconazole on the pharmacokinetics of doravirine (MK-1439), a novel non-nucleoside reverse transcriptase inhibitor for the treatment of HIV-1 infection.\n                      16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy.\n                      26\u201328 May 2015, Washington, DC, USA. Abstract 58"},{"key":"bibr12-IMP3324","unstructured":"Khalilieh S., Anderson M., Laethem T. Multiple-dose treatment with ritonavir increases the exposure of doravirine.\n                      Conference on Retroviruses and Opportunistic Infections (CROI).\n                      13\u201316 February, 2017, Seattle, WA, USA. Abstract 412"},{"key":"bibr13-IMP3324","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-017-0513-4"},{"key":"bibr14-IMP3324","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01757-16"},{"key":"bibr15-IMP3324","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02492-18"},{"key":"bibr16-IMP3324","doi-asserted-by":"publisher","DOI":"10.3851\/IMP2920"},{"key":"bibr17-IMP3324","doi-asserted-by":"publisher","DOI":"10.17265\/2159-5313\/2016.09.003"},{"key":"bibr18-IMP3324","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-016-0458-4"},{"key":"bibr19-IMP3324","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01364-16"},{"key":"bibr20-IMP3324","unstructured":"GlaxoSmithKline\/ViiV Healthcare. Epivir (lamivudine) Prescribing Information. 2018. (Accessed 8 March 2019.) Available from https:\/\/www.gsksource.com\/pharma\/content\/dam\/GlaxoSmithKline\/US\/en\/Prescribing_Information\/Epivir\/pdf\/EPIVIR-PI-PIL.PDF"},{"key":"bibr21-IMP3324","unstructured":"Gilead Sciences Inc. Viread (tenofovir disproxil fumarate) prescribing information. 2018. (Accessed 8 March 2019.) Available from http:\/\/www.gilead.com\/\u223c\/media\/Files\/pdfs\/medicines\/liver-disease\/viread\/viread_pi.pdf"},{"key":"bibr22-IMP3324","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200443090-00003"},{"key":"bibr23-IMP3324","doi-asserted-by":"publisher","DOI":"10.1177\/0091270005281351"},{"key":"bibr24-IMP3324","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.6.2091-2096.2004"},{"key":"bibr25-IMP3324","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.17.4.19532"},{"key":"bibr26-IMP3324","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.104.065342"},{"key":"bibr27-IMP3324","doi-asserted-by":"publisher","DOI":"10.1016\/j.bcp.2007.01.027"},{"key":"bibr28-IMP3324","unstructured":"FDA. Clinical drug interaction studies \u2014 study design, data analysis, and clinical implications. Guidance for industry. 2017. (Accessed 10 July 2018.) Available from https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm292362.pdf"},{"key":"bibr29-IMP3324","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-017-0512-5"}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP3324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.3851\/IMP3324","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP3324","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:52:48Z","timestamp":1777380768000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.3851\/IMP3324"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8,1]]},"references-count":29,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2019,8]]}},"alternative-id":["10.3851\/IMP3324"],"URL":"https:\/\/doi.org\/10.3851\/imp3324","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8,1]]}}}