{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T11:30:57Z","timestamp":1789731057748,"version":"4.0.1"},"reference-count":39,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T00:00:00Z","timestamp":1717545600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009633","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"}]},{"DOI":"10.13039\/100000002","name":"NIH","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\/100000002","name":"NIH","doi-asserted-by":"publisher","award":["UM1AI068616"],"award-info":[{"award-number":["UM1AI068616"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","award":["UM1AI106716"],"award-info":[{"award-number":["UM1AI106716"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","award":["HHSN275201800001I"],"award-info":[{"award-number":["HHSN275201800001I"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005564","name":"Gilead Sciences, Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,10,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Pregnant people with coronavirus disease 2019 (COVID-19) experience higher risk for severe disease and adverse pregnancy outcomes, but no pharmacokinetic (PK) data exist to support dosing of COVID-19 therapeutics during pregnancy. We report PK and safety data for intravenous remdesivir in pregnancy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>IMPAACT 2032 was a phase 4 prospective, open-label, nonrandomized opportunistic study of hospitalized pregnant and nonpregnant women receiving intravenous remdesivir as part of clinical care. Intensive PK sampling was performed on infusion days 3, 4, or 5 with collection of plasma and peripheral blood mononuclear cells (PBMCs). Safety data were recorded from first infusion through 4 weeks after last infusion and at delivery. Geometric mean ratios (GMR) (90% confidence intervals [CI]) of PK parameters between pregnant and nonpregnant women were calculated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Fifty-three participants initiated remdesivir (25 pregnant; median gestational age, 27.6 weeks; interquartile range, 24.9\u201331.0 weeks). Plasma exposures of remdesivir, its 2 major metabolites (GS-704277 and GS-441524), and the free remdesivir fraction were similar between pregnant and nonpregnant participants. Concentrations of the active triphosphate (GS-443902) in PBMCs increased 2.04-fold (90% CI, 1.35\u20133.03) with each additional infusion in nonpregnant versus pregnant participants. Three adverse events in nonpregnant participants were related to treatment (1 grade 3; 2 grade 2 resulting in treatment discontinuation). There were no treatment-related adverse pregnancy outcomes or congenital anomalies detected.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Plasma remdesivir PK parameters were comparable between pregnant and nonpregnant women, and no safety concerns were identified based on our limited data. These findings suggest no dose adjustments are indicated for intravenous remdesivir during pregnancy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT04582266.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae298","type":"journal-article","created":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T23:40:14Z","timestamp":1717630814000},"page":"878-888","source":"Crossref","is-referenced-by-count":9,"title":["Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032"],"prefix":"10.1093","volume":"230","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3832-8699","authenticated-orcid":false,"given":"Kristina M","family":"Brooks","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus , Aurora, Colorado ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2090-9513","authenticated-orcid":false,"given":"Kristin","family":"Baltrusaitis","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana F","family":"Clarke","sequence":"additional","affiliation":[{"name":"Section of Pediatric Infectious Diseases, Boston Medical Center , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3419-9471","authenticated-orcid":false,"given":"Sharon","family":"Nachman","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases, Stony Brook Children's Hospital , Stony Brook, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Jao","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases, Division of Adult Infectious Diseases, Feinberg School of Medicine, Northwestern University , Chicago, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murli U","family":"Purswani","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases, BronxCare Health System , Bronx, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Agwu","sequence":"additional","affiliation":[{"name":"Department of Pediatric Infectious Disease, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christy","family":"Beneri","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases, Stony Brook Children's Hospital , Stony Brook, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaime G","family":"Deville","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles , Los Angeles, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen M","family":"Powis","sequence":"additional","affiliation":[{"name":"Departments of Medicine and Pediatrics, Massachusetts General Hospital , Boston, Massachusetts ,","place":["USA"]},{"name":"Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice M","family":"Stek","sequence":"additional","affiliation":[{"name":"Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California , Los Angeles, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahizechukwu C","family":"Eke","sequence":"additional","affiliation":[{"name":"Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]},{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmund","family":"Capparelli","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego , La Jolla, California ,","place":["USA"]},{"name":"Pediatrics Department, School of Medicine-Rady Children's Hospital San Diego, University of California San Diego , San Diego, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Greene","sequence":"additional","affiliation":[{"name":"IMPAACT Operations Center, FHI 360 , Durham North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"George","sequence":"additional","affiliation":[{"name":"IMPAACT Operations Center, FHI 360 , Durham North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dwight E","family":"Yin","sequence":"additional","affiliation":[{"name":"Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Rockville, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Jean-Philippe","sequence":"additional","affiliation":[{"name":"Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Rockville, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nahida","family":"Chakhtoura","sequence":"additional","affiliation":[{"name":"National Institute of Child Health and Human Development, National Institutes of Health , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederic","family":"Bone","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation, Inc , Amherst, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kira","family":"Bacon","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation, Inc , Amherst, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Johnston","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation, Inc , Amherst, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Reding","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation, Inc , Amherst, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Kersey","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Humeniuk","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brookie M","family":"Best","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego , La Jolla, California ,","place":["USA"]},{"name":"Pediatrics Department, School of Medicine-Rady Children's Hospital San Diego, University of California San Diego , San Diego, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Division of Neonatalogy, Chobanian and Avedisian School of Medicine, Boston University , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah D","family":"Momper","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego , La Jolla, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"IMPAACT 2032 Study Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuela","family":"Lartey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit","family":"Kalra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"Yee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James Etta","family":"Stewart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"Cavallo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirza","family":"Baig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleisha","family":"Collinson-Streng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thuy","family":"Anderson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie","family":"Addison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barsha","family":"Chakraborty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia","family":"Avila","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Caso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Janzen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele F","family":"Carter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Paul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth","family":"Eser-Jose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariam","family":"Pontifes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chivon McMullen","family":"Jackson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolette","family":"Gomez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"Alvarez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"JoNell","family":"Potter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina L","family":"Badell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sierra","family":"Jordan-Thompson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riaun","family":"Floyd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"LaTeshia","family":"Thomas-Seaton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana","family":"Weinberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane","family":"Curran-Hays","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Kwon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carrie","family":"Glenny","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariam","family":"Aziz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maureen","family":"McNichols","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,6,5]]},"reference":[{"key":"2024101612564609000_jiae298-B1","doi-asserted-by":"crossref","first-page":"e009495","DOI":"10.1136\/bmjgh-2022-009495","article-title":"Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis","volume":"8","author":"Smith","year":"2023","journal-title":"BMJ Glob Health"},{"key":"2024101612564609000_jiae298-B2","doi-asserted-by":"crossref","first-page":"m3320","DOI":"10.1136\/bmj.m3320","article-title":"Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis","volume":"370","author":"Allotey","year":"2020","journal-title":"BMJ"},{"key":"2024101612564609000_jiae298-B3","doi-asserted-by":"crossref","first-page":"e237149","DOI":"10.1001\/jamanetworkopen.2023.7149","article-title":"Severe maternal morbidity and mortality of pregnant patients with COVID-19 infection during the early pandemic period in the US","volume":"6","author":"Matsuo","year":"2023","journal-title":"JAMA Netw Open"},{"key":"2024101612564609000_jiae298-B4","doi-asserted-by":"crossref","first-page":"1693","DOI":"10.1038\/s41591-021-01490-8","article-title":"Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy","volume":"27","author":"Dagan","year":"2021","journal-title":"Nat Med"},{"key":"2024101612564609000_jiae298-B5","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1186\/s12884-022-05101-3","article-title":"Timing and severity of COVID-19 during pregnancy and risk of preterm birth in the International Registry of Coronavirus Exposure in Pregnancy","volume":"22","author":"Smith","year":"2022","journal-title":"BMC Pregnancy Childbirth"},{"key":"2024101612564609000_jiae298-B6","doi-asserted-by":"crossref","first-page":"1813","DOI":"10.1056\/NEJMoa2007764","article-title":"Remdesivir for the treatment of COVID-19\u2014preliminary report.","volume":"383","author":"Beigel","year":"2020","journal-title":"N Engl J Med"},{"key":"2024101612564609000_jiae298-B7","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1056\/NEJMoa2116846","article-title":"Early remdesivir to prevent progression to severe COVID-19 in outpatients","volume":"386","author":"Gottlieb","year":"2022","journal-title":"N Engl J Med"},{"key":"2024101612564609000_jiae298-B8","doi-asserted-by":"crossref","first-page":"569","DOI":"10.1007\/s40262-021-00984-5","article-title":"Pharmacokinetic, pharmacodynamic, and drug-interaction profile of remdesivir, a SARS-CoV-2 replication inhibitor","volume":"60","author":"Humeniuk","year":"2021","journal-title":"Clin Pharmacokinet"},{"key":"2024101612564609000_jiae298-B9","doi-asserted-by":"crossref","first-page":"e3996","DOI":"10.1093\/cid\/ciaa1466","article-title":"Compassionate use of remdesivir in pregnant women with severe coronavirus disease 2019","volume":"73","author":"Burwick","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2024101612564609000_jiae298-B10","doi-asserted-by":"crossref","first-page":"5970","DOI":"10.1080\/14767058.2021.1903426","article-title":"Pharmacological treatment in pregnant women with moderate symptoms of coronavirus disease 2019 (COVID-19) pneumonia","volume":"35","author":"Nasrallah","year":"2022","journal-title":"J Matern Fetal Neonatal Med"},{"key":"2024101612564609000_jiae298-B11","doi-asserted-by":"crossref","first-page":"113399","DOI":"10.1016\/j.ab.2019.113399","article-title":"The determination of human peripheral blood mononuclear cell counts using a genomic DNA standard and application in tenofovir diphosphate quantitation","volume":"585","author":"Xiao","year":"2019","journal-title":"Anal Biochem"},{"key":"2024101612564609000_jiae298-B12","doi-asserted-by":"crossref","first-page":"114118","DOI":"10.1016\/j.ab.2021.114118","article-title":"Validation of LC-MS\/MS methods for determination of remdesivir and its metabolites GS-441524 and GS-704277 in acidified human plasma and their application in COVID-19 related clinical studies","volume":"617","author":"Xiao","year":"2021","journal-title":"Anal Biochem"},{"key":"2024101612564609000_jiae298-B13","doi-asserted-by":"crossref","first-page":"896","DOI":"10.1111\/cts.12840","article-title":"Safety, tolerability, and pharmacokinetics of remdesivir, an antiviral for treatment of COVID-19, in healthy subjects","volume":"13","author":"Humeniuk","year":"2020","journal-title":"Clin Transl Sci"},{"key":"2024101612564609000_jiae298-B14","author":"US Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS"},{"key":"2024101612564609000_jiae298-B15","doi-asserted-by":"crossref","first-page":"107940","DOI":"10.1016\/j.celrep.2020.107940","article-title":"Remdesivir inhibits SARS-CoV-2 in human lung cells and chimeric SARS-CoV expressing the SARS-CoV-2 RNA polymerase in mice","volume":"32","author":"Pruijssers","year":"2020","journal-title":"Cell Rep"},{"key":"2024101612564609000_jiae298-B16","article-title":"Pharmacokinetics inform remdesivir dosing in patients with severe renal impairment","author":"Humeniuk","year":"2023"},{"key":"2024101612564609000_jiae298-B17","article-title":"Dosing recommendation for remdesivir in pediatric COVID-19 patients","author":"Humeniuk","year":"2022"},{"key":"2024101612564609000_jiae298-B18"},{"key":"2024101612564609000_jiae298-B19","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1002\/psp4.12900","article-title":"Physiologically-based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID-19","volume":"12","author":"Liu","year":"2023","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"2024101612564609000_jiae298-B20","volume-title":"Veklury","author":"Gilead Sciences","year":"2023"},{"key":"2024101612564609000_jiae298-B21","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1016\/j.sjbs.2021.09.042","article-title":"Molecular modelling studies unveil potential binding sites on human serum albumin for selected experimental and in silico COVID-19 drug candidate molecules","volume":"29","author":"Gurung","year":"2022","journal-title":"Saudi J Biol Sci"},{"key":"2024101612564609000_jiae298-B22","doi-asserted-by":"crossref","first-page":"1497","DOI":"10.1002\/psp4.12718","article-title":"Elevated acute phase proteins affect pharmacokinetics in COVID-19 trials: lessons from the CounterCOVID-imatinib study","volume":"10","author":"Bartelink","year":"2021","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"2024101612564609000_jiae298-B23","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1002\/cpt.2099","article-title":"Toward consensus on correct interpretation of protein binding in plasma and other biological matrices for COVID-19 therapeutic development","volume":"110","author":"Boffito","year":"2021","journal-title":"Clin Pharmacol Ther"},{"key":"2024101612564609000_jiae298-B24","doi-asserted-by":"crossref","first-page":"721059","DOI":"10.3389\/fped.2021.721059","article-title":"Characterization of plasma protein alterations in pregnant and postpartum individuals living with HIV to support physiologically-based pharmacokinetic model development","volume":"9","author":"Zhao","year":"2021","journal-title":"Front Pediatr"},{"key":"2024101612564609000_jiae298-B25","doi-asserted-by":"crossref","first-page":"365","DOI":"10.2165\/11597440-000000000-00000","article-title":"Anatomical, physiological and metabolic changes with gestational age during normal pregnancy: a database for parameters required in physiologically based pharmacokinetic modelling","volume":"51","author":"Abduljalil","year":"2012","journal-title":"Clin Pharmacokinet"},{"key":"2024101612564609000_jiae298-B26","doi-asserted-by":"crossref","first-page":"1303","DOI":"10.1007\/s40262-017-0539-z","article-title":"Gestation-specific changes in the anatomy and physiology of healthy pregnant women: an extended repository of model parameters for physiologically based pharmacokinetic modeling in pregnancy","volume":"56","author":"Dallmann","year":"2017","journal-title":"Clin Pharmacokinet"},{"key":"2024101612564609000_jiae298-B27","doi-asserted-by":"crossref","first-page":"2159","DOI":"10.1097\/00002030-200310170-00003","article-title":"Antiviral dynamics and sex differences of zidovudine and lamivudine triphosphate concentrations in HIV-infected individuals","volume":"17","author":"Anderson","year":"2003","journal-title":"AIDS"},{"key":"2024101612564609000_jiae298-B28","doi-asserted-by":"crossref","first-page":"738","DOI":"10.1093\/jac\/dkn247","article-title":"Cytokine and sex hormone effects on zidovudine- and lamivudine-triphosphate concentrations in vitro","volume":"62","author":"Anderson","year":"2008","journal-title":"J Antimicrob Chemother"},{"key":"2024101612564609000_jiae298-B29","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1097\/QAI.0000000000000529","article-title":"Reduced immune activation during tenofovir-emtricitabine therapy in HIV-negative individuals","volume":"68","author":"Castillo-Mancilla","year":"2015","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2024101612564609000_jiae298-B30","doi-asserted-by":"crossref","first-page":"981","DOI":"10.1089\/aid.2016.0008","article-title":"Intracellular tenofovir and emtricitabine anabolites in genital, rectal, and blood compartments from first dose to steady state","volume":"32","author":"Seifert","year":"2016","journal-title":"AIDS Res Hum Retroviruses"},{"key":"2024101612564609000_jiae298-B31","doi-asserted-by":"crossref","first-page":"624","DOI":"10.1002\/cpt.2445","article-title":"Whole body PBPK modeling of remdesivir and its metabolites to aid in estimating active metabolite exposure in the lung and liver in patients with organ dysfunction","volume":"111","author":"Fan","year":"2022","journal-title":"Clin Pharmacol Ther"},{"key":"2024101612564609000_jiae298-B32","doi-asserted-by":"crossref","first-page":"e695","DOI":"10.1093\/cid\/ciaa1419","article-title":"Risk factors for coronavirus disease 2019 (COVID-19)-associated hospitalization: COVID-19-associated hospitalization surveillance network and behavioral risk factor surveillance system","volume":"72","author":"Ko","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2024101612564609000_jiae298-B33","doi-asserted-by":"crossref","first-page":"e2255815","DOI":"10.1001\/jamanetworkopen.2022.55815","article-title":"Identification of bradycardia following remdesivir administration through the US food and drug administration American College of Medical Toxicology COVID-19 toxic pharmacovigilance project","volume":"6","author":"Devgun","year":"2023","journal-title":"JAMA Netw Open"},{"key":"2024101612564609000_jiae298-B34","doi-asserted-by":"crossref","first-page":"1648","DOI":"10.1161\/CIRCULATIONAHA.120.046941","article-title":"COVID-19 and cardiovascular disease","volume":"141","author":"Clerkin","year":"2020","journal-title":"Circulation"},{"key":"2024101612564609000_jiae298-B35","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1038\/s41591-022-01689-3","article-title":"Long-term cardiovascular outcomes of COVID-19","volume":"28","author":"Xie","year":"2022","journal-title":"Nat Med"},{"key":"2024101612564609000_jiae298-B36","doi-asserted-by":"crossref","first-page":"e08835","DOI":"10.1016\/j.heliyon.2022.e08835","article-title":"Remdesivir for pregnancy: a systematic review of antiviral therapy for COVID-19","volume":"8","author":"Budi","year":"2022","journal-title":"Heliyon"},{"key":"2024101612564609000_jiae298-B37","doi-asserted-by":"crossref","first-page":"9445","DOI":"10.1080\/14767058.2022.2041595","article-title":"Remdesivir use in pregnancy during the SARS-CoV-2 pandemic","volume":"35","author":"Gutierrez","year":"2022","journal-title":"J Matern Fetal Neonatal Med"},{"key":"2024101612564609000_jiae298-B38","doi-asserted-by":"crossref","first-page":"792","DOI":"10.1055\/s-0040-1712103","article-title":"Exclusion of pregnant women from clinical trials during the coronavirus disease 2019 pandemic: a review of international registries","volume":"37","author":"Smith","year":"2020","journal-title":"Am J Perinatol"},{"key":"2024101612564609000_jiae298-B39","doi-asserted-by":"crossref","first-page":"1254","DOI":"10.1093\/cid\/ciz121","article-title":"Importance of prospective studies in pregnant and breastfeeding women living with human immunodeficiency virus","volume":"69","author":"Colbers","year":"2019","journal-title":"Clin Infect Dis"}],"container-title":["The Journal of Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jid\/advance-article-pdf\/doi\/10.1093\/infdis\/jiae298\/58378797\/jiae298.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jid\/article-pdf\/230\/4\/878\/59789641\/jiae298.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jid\/article-pdf\/230\/4\/878\/59789641\/jiae298.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T12:57:10Z","timestamp":1729083430000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jid\/article\/230\/4\/878\/7688437"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,5]]},"references-count":39,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2024,6,5]]},"published-print":{"date-parts":[[2024,10,16]]}},"URL":"https:\/\/doi.org\/10.1093\/infdis\/jiae298","relation":{},"ISSN":["0022-1899","1537-6613"],"issn-type":[{"value":"0022-1899","type":"print"},{"value":"1537-6613","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,10,15]]},"published":{"date-parts":[[2024,6,5]]}}}