{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T22:00:19Z","timestamp":1792101619191,"version":"4.4.0"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T00:00:00Z","timestamp":1627516800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI068632"],"award-info":[{"award-number":["UM1AI068632"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007880","name":"Johns Hopkins University","doi-asserted-by":"publisher","award":["UM1AI068616"],"award-info":[{"award-number":["UM1AI068616"]}],"id":[{"id":"10.13039\/100007880","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007880","name":"Johns Hopkins University","doi-asserted-by":"publisher","award":["UM1AI106716"],"award-info":[{"award-number":["UM1AI106716"]}],"id":[{"id":"10.13039\/100007880","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["HHSN275201800001I"],"award-info":[{"award-number":["HHSN275201800001I"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["2 UM1 AI0686\u201315"],"award-info":[{"award-number":["2 UM1 AI0686\u201315"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006392","name":"AIDS Clinical Trials Group","doi-asserted-by":"publisher","award":["UM1 AI068634"],"award-info":[{"award-number":["UM1 AI068634"]}],"id":[{"id":"10.13039\/100006392","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006392","name":"AIDS Clinical Trials Group","doi-asserted-by":"publisher","award":["UM1 AI068636"],"award-info":[{"award-number":["UM1 AI068636"]}],"id":[{"id":"10.13039\/100006392","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006392","name":"AIDS Clinical Trials Group","doi-asserted-by":"publisher","award":["UM1 AI106701"],"award-info":[{"award-number":["UM1 AI106701"]}],"id":[{"id":"10.13039\/100006392","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]},{"name":"J. S. M.","award":["NIH K23AI129854"],"award-info":[{"award-number":["NIH K23AI129854"]}]},{"name":"A. G.","award":["NIH UM1AI069465"],"award-info":[{"award-number":["NIH UM1AI069465"]}]},{"name":"K. E. D.","award":["NIH K24AI150349"],"award-info":[{"award-number":["NIH K24AI150349"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Pregnancy increases the risk of tuberculosis and its complications. A 3-month regimen of weekly isoniazid and rifapentine (3HP) is safe and effective for tuberculosis prevention in adults and children, including those with HIV, but 3HP has not been evaluated in pregnancy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>IMPAACT 2001 was a phase I\/II trial evaluating the pharmacokinetics and safety of 3HP among pregnant women with indications for tuberculosis preventative therapy in Haiti, Kenya, Malawi, Thailand, and Zimbabwe (NCT02651259). Isoniazid and rifapentine were provided at standard doses (900 mg\/week). Pharmacokinetic sampling was performed with the first (second\/third trimester) and twelfth (third trimester\/postpartum) doses. Nonlinear mixed-effects models were used to estimate drug population pharmacokinetics.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 50 participants, 20 had HIV and were taking efavirenz-based antiretroviral therapy. Among women without HIV, clearance of rifapentine was 28% lower during pregnancy than postpartum (1.20 vs 1.53 L\/hour, P\u2005&amp;lt;\u2005.001), with area under the concentration-time curve (AUCSS) of 786 and 673 mg \u00d7 hour\/L, respectively. In pregnant women with HIV, clearance was 30% higher than women without HIV (P\u2005&amp;lt;\u2005.001), resulting in lower AUCss (522 mg \u00d7 hour\/L); clearance did not change significantly between pregnancy and postpartum. Pregnancy did not impact isoniazid pharmacokinetics. There were no drug-related serious adverse events, treatment discontinuations, or tuberculosis cases in women or infants.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>3HP does not require dose adjustment in pregnancy. Rifapentine clearance is higher among women with HIV, but all women achieved exposures of rifapentine and isoniazid associated with successful tuberculosis prevention. The data support proceeding with larger safety-focused studies of 3HP in pregnancy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>ClinicalTrials.gov, NCT02651259.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab665","type":"journal-article","created":{"date-parts":[[2021,7,28]],"date-time":"2021-07-28T19:13:31Z","timestamp":1627499611000},"page":"1604-1613","source":"Crossref","is-referenced-by-count":33,"title":["Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women"],"prefix":"10.1093","volume":"74","author":[{"given":"Jyoti S","family":"Mathad","sequence":"first","affiliation":[{"name":"Department of Medicine and Obstetrics and Gynecology, Center for Global Health, Weill Cornell Medicine, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rada","family":"Savic","sequence":"additional","affiliation":[{"name":"University of California\u2013San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Britto","sequence":"additional","affiliation":[{"name":"Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priya","family":"Jayachandran","sequence":"additional","affiliation":[{"name":"University of California\u2013San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9070-8699","authenticated-orcid":false,"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6866-4335","authenticated-orcid":false,"given":"Grace","family":"Montepiedra","sequence":"additional","affiliation":[{"name":"Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Norman","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Zhang","sequence":"additional","affiliation":[{"name":"University of California\u2013San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen","family":"Townley","sequence":"additional","affiliation":[{"name":"Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nahida","family":"Chakhtoura","sequence":"additional","affiliation":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Bradford","sequence":"additional","affiliation":[{"name":"FHI 360, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandesh","family":"Patil","sequence":"additional","affiliation":[{"name":"BJ Medical College\u2013Johns Hopkins CTU, Pune, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Popson","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation, Inc, Amherst, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsungai","family":"Chipato","sequence":"additional","affiliation":[{"name":"University of Zimbabwe College of Health Sciences\u2013Clinical Trials Research Centre, Harare, Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Rouzier","sequence":"additional","affiliation":[{"name":"Department of 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