{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T16:08:42Z","timestamp":1768320522354,"version":"3.49.0"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"11","funder":[{"DOI":"10.13039\/100000200","name":"USAID","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000030","name":"Centers for Disease Control and Prevention","doi-asserted-by":"publisher","award":["USAID\/CDC IAA AID-GH-T-15-00002"],"award-info":[{"award-number":["USAID\/CDC IAA AID-GH-T-15-00002"]}],"id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,22]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Tenofovir alafenamide (TAF)-based regimens are being evaluated for pre-exposure prophylaxis (PrEP). We used a macaque model of repeated exposures to simian human immunodeficiency virus (SHIV) to investigate whether TAF alone or the combination of TAF and emtricitabine (FTC) can prevent vaginal infection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Pigtail macaques were exposed vaginally to SHIV162p3 once a week for up to 15 weeks. Animals received clinical doses of FTC\/TAF (n = 6) or TAF (n = 9) orally 24 hours before and 2 hours after each weekly virus exposure. Infection was compared with 21 untreated controls.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Five of the 6 animals in the FTC\/TAF and 4 of the 9 animals in the TAF alone group were protected against infection (P = .001 and P = .049, respectively). The calculated efficacy of FTC\/TAF and TAF was 91% (95% confidence interval [CI], 34.9%\u201398.8%) and 57.8% (95% CI, \u22128.7% to 83.6%), respectively. Infection in FTC\/TAF but not TAF-treated macaques was delayed relative to controls (P = .005 and P = .114). Median tenofovir diphosphate (TFV-DP) levels in peripheral blood mononuclear cells (PBMCs) were similar among infected and uninfected macaques receiving TAF PrEP (351 and 143 fmols\/106 cells, respectively; P = .921).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Emtricitabine\/TAF provided a level of protection against vaginal challenge similar to FTC\/TFV disoproxil fumarate combination in the macaque model. Our results support the clinical evaluation of FTC\/TAF for PrEP in women.<\/jats:p><\/jats:sec>","DOI":"10.1093\/infdis\/jiz383","type":"journal-article","created":{"date-parts":[[2019,7,24]],"date-time":"2019-07-24T11:11:47Z","timestamp":1563966707000},"page":"1826-1833","source":"Crossref","is-referenced-by-count":24,"title":["Efficacy of Oral Tenofovir Alafenamide\/Emtricitabine Combination or Single-Agent Tenofovir Alafenamide Against Vaginal Simian Human Immunodeficiency Virus Infection in Macaques"],"prefix":"10.1093","volume":"220","author":[{"given":"Ivana","family":"Massud","sequence":"first","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mian-Er","family":"Cong","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for 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Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenji","family":"Nishiura","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Khalil","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Pan","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Lipscomb","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryan","family":"Johnson","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Deyounks","sequence":"additional","affiliation":[{"name":"Division of HIV\/AIDS Prevention, National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James 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