{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T21:05:13Z","timestamp":1791666313852,"version":"4.3.4"},"reference-count":14,"publisher":"Oxford University Press (OUP)","issue":"10","funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"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"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,11,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Ebola virus RNA persists in the semen of male Ebola survivors for months to years after the acute infection, and male-to-female sexual transmission of the virus is well documented. We investigated whether remdesivir can safely reduce persistence of seminal Ebola virus RNA.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We recruited men with persistent seminal Ebola RNA in Liberia and Guinea. Participants were randomized 1:1 to receive intravenous remdesivir (GS-5734; Gilead Sciences) or matching placebo administered once daily by intravenous infusion over 1 hour on 5 consecutive days. Stratification was by country and number of positive (1 or 2) preenrollment semen tests. We evaluated the difference in mean assay negativity rate (ANR), that is, the proportion of negative tests for each participant in each group in the treatment (days 1\u201328) and follow-up (months 2\u20136) phases on an intention-to-treat basis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We enrolled 38 men from July 2016 through June 2018. The mean treatment phase ANRs were 85% (standard deviation [SD]\u2005=\u200524%) and 76% (SD\u2005=\u200530%) in the remdesivir and placebo arms, respectively (P\u2005=\u2005.270). The mean follow-up phase ANRs were 96% (SD\u2005=\u200510%) and 81% (SD\u2005=\u200529%) in the remdesivir and placebo arms, respectively (P\u2005=\u2005.041). The 5-day remdesivir regimen was well tolerated with no safety concerns.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In this small trial, remdesivir 100 mg\/day for 5 days safely reduced the presence of Ebola virus RNA in the semen of Ebola survivors 2 to 6 months after administration. A larger follow-up study is necessary to confirm results.<\/jats:p>\n                  <jats:p>Clinical Trials Registration . NCT02818582<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab215","type":"journal-article","created":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T12:20:15Z","timestamp":1615465215000},"page":"1849-1856","source":"Crossref","is-referenced-by-count":45,"title":["PREVAIL IV: A Randomized, Double-Blind, 2-Phase, Phase 2 Trial of Remdesivir vs Placebo for Reduction of Ebola Virus RNA in the Semen of Male Survivors"],"prefix":"10.1093","volume":"73","author":[{"given":"Elizabeth S","family":"Higgs","sequence":"first","affiliation":[{"name":"Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dehkontee","family":"Gayedyu-Dennis","sequence":"additional","affiliation":[{"name":"Duport Road Clinic, Paynesville, Liberia Partnership for Research on Ebola Virus in Liberia, Monrovia, Liberia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William A","family":"Fischer II","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, University of North Carolina, Chapel Hill, North Carolina, USA"},{"name":"USA Institute of Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"Nason","sequence":"additional","affiliation":[{"name":"Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cavan","family":"Reilly","sequence":"additional","affiliation":[{"name":"Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdoul Habib","family":"Beavogui","sequence":"additional","affiliation":[{"name":"Centre National de Formation et de Recherche en Sant\u00e9 Rurale de Maferinyah, Forecariah, Guinea"},{"name":"Bioclinical and Fundamental Sciences Chair, Department of Medical Sciences, Faculty of Health Science and Techniques, Gamal Abdel Nasser University of Conakry, Conakry, Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamila","family":"Aboulhab","sequence":"additional","affiliation":[{"name":"Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"Nordwall","sequence":"additional","affiliation":[{"name":"Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Princess","family":"Lobbo","sequence":"additional","affiliation":[{"name":"Duport Road Clinic, Paynesville, Liberia Partnership for Research on Ebola Virus in Liberia, Monrovia, Liberia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Wachekwa","sequence":"additional","affiliation":[{"name":"John F. Kennedy Medical Center, Monrovia, Liberia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huyen","family":"Cao","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomas","family":"Cihlar","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Foster City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Hensley","sequence":"additional","affiliation":[{"name":"Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H Clifford","family":"Lane","sequence":"additional","affiliation":[{"name":"Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,3,12]]},"reference":[{"key":"2022020900122051700_CIT0001","doi-asserted-by":"crossref","first-page":"1428","DOI":"10.1056\/NEJMoa1511410","article-title":"Ebola RNA persistence in semen of Ebola virus disease survivors","volume":"377","author":"Deen","year":"2017","journal-title":"N Engl J Med"},{"key":"2022020900122051700_CIT0002","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1056\/NEJMoa1805435","article-title":"A longitudinal study of Ebola sequelae in Liberia","volume":"380","author":"Sneller","year":"2019","journal-title":"N Engl J Med"},{"key":"2022020900122051700_CIT0003","doi-asserted-by":"crossref","first-page":"498","DOI":"10.1016\/S0140-6736(16)30386-5","article-title":"Late Ebola virus relapse causing meningoencephalitis: a case report","volume":"388","author":"Jacobs","year":"2016","journal-title":"Lancet"},{"key":"2022020900122051700_CIT0004","doi-asserted-by":"crossref","first-page":"2423","DOI":"10.1056\/NEJMoa1500306","article-title":"Persistence of Ebola virus in ocular fluid during convalescence","volume":"372","author":"Varkey","year":"2015","journal-title":"N Engl J Med"},{"key":"2022020900122051700_CIT0005","doi-asserted-by":"crossref","first-page":"308","DOI":"10.1016\/S1473-3099(18)30649-2","article-title":"Prevalence of infection among asymptomatic and paucisymptomatic contact persons exposed to Ebola virus in Guinea: a retrospective, cross-sectional observational study","volume":"19","author":"Diallo","year":"2019","journal-title":"Lancet Infect Dis"},{"key":"2022020900122051700_CIT0006","doi-asserted-by":"crossref","first-page":"1015","DOI":"10.1016\/S1473-3099(18)30417-1","article-title":"Persistence of Ebola virus after the end of widespread transmission in Liberia: an outbreak report","volume":"18","author":"Dokubo","year":"2018","journal-title":"Lancet Infect Dis"},{"key":"2022020900122051700_CIT0007","doi-asserted-by":"crossref","first-page":"1653","DOI":"10.1038\/s41598-018-38397-3","article-title":"Effect of sexual transmission on the West Africa Ebola outbreak in 2014: a mathematical modelling study","volume":"9","author":"Luo","year":"2019","journal-title":"Sci Rep"},{"key":"2022020900122051700_CIT0008","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1016\/S1473-3099(16)30516-3","article-title":"Multidisciplinary assessment of post-Ebola sequelae in Guinea (Postebogui): an observational cohort study","volume":"17","author":"Etard","year":"2017","journal-title":"Lancet Infect Dis"},{"key":"2022020900122051700_CIT0009","doi-asserted-by":"crossref","first-page":"2293","DOI":"10.1056\/NEJMoa1910993","article-title":"A randomized, controlled trial of Ebola virus disease therapeutics","volume":"381","author":"Mulangu","year":"2019","journal-title":"N Engl J Med"},{"key":"2022020900122051700_CIT0010","author":"FDA","year":"2020."},{"key":"2022020900122051700_CIT0011","author":"FDA","year":"2020."},{"key":"2022020900122051700_CIT0012","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1038\/nature17180","article-title":"Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys","volume":"531","author":"Warren","year":"2016","journal-title":"Nature"},{"key":"2022020900122051700_CIT0013","doi-asserted-by":"crossref","first-page":"1237","DOI":"10.1093\/infdis\/jiv454","article-title":"Use of existing diagnostic reverse-transcription polymerase chain reaction assays for detection of Ebola virus RNA in semen","volume":"213","author":"Pettitt","year":"2016","journal-title":"J Infect Dis"},{"key":"2022020900122051700_CIT0014","doi-asserted-by":"crossref","first-page":"1813","DOI":"10.1056\/NEJMoa2007764","article-title":"Remdesivir for the treatment of Covid-19","volume":"383","author":"Beigel","year":"2020","journal-title":"N Engl J Med"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciab215\/40809275\/ciab215.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/73\/10\/1849\/42388474\/ciab215.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/73\/10\/1849\/42388474\/ciab215.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,9]],"date-time":"2022-02-09T00:28:02Z","timestamp":1644366482000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/73\/10\/1849\/6168541"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,12]]},"references-count":14,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2021,3,12]]},"published-print":{"date-parts":[[2021,11,16]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciab215","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,11,15]]},"published":{"date-parts":[[2021,3,12]]}}}