{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T10:10:48Z","timestamp":1790763048194,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,5,26]],"date-time":"2024-05-26T00:00:00Z","timestamp":1716681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Antiretrovirals (ARVs) are life\u2010saving drugs used for the treatment and prevention of HIV infection and antiviral drugs (AVs) for the treatment of chronic HBV infection. ARVs have proven highly effective in reducing perinatal HIV transmission, however the risk of birth defects from prenatal exposure to ARVs\/AVs is an ongoing concern. The Antiretroviral Pregnancy Registry (APR), an international, prospective exposure\u2010registration cohort study, monitors ARV and AV use in pregnancy for early signals of teratogenicity. This communication reports results of 30\u2010years' experience of ARV\/AV exposure during pregnancy and lessons learned through continuous quality improvement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>Birth defect prevalence is estimated and compared to internal and external groups. Statistical inference is based on exact methods for binomial proportions. Between 2006 and 2023, cumulative enrollment more than tripled from 6893 to 25\u2009960 pregnancies and ARVs\/AVs monitored increased from 29 to 222. Through January 2023, there were 21\u2009636 live births and 631 outcomes with birth defects, for overall prevalence of 2.9\/100 live births (95% CI 2.7, 3.2). The birth defect prevalence was 3.0% (95% CI 2.7%, 3.3%) among first trimester exposures and 2.8% (95% CI 2.5%, 3.2%) among second\/third trimester exposures (prevalence ratio 1.04 [95% CI 0.89, 1.21]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Birth defect prevalence is not statistically significantly different between first trimester ARV\/AV pregnancy exposures compared to second\/third trimester exposures and is also not different from two population\u2010based surveillance systems: 2.72\/100 live births reported in the Metropolitan Atlanta Congenital Defects Program (MACDP); and 4.17\/100 live births from the Texas Birth Defects Registry (TBDR).<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5801","type":"journal-article","created":{"date-parts":[[2024,5,27]],"date-time":"2024-05-27T06:33:35Z","timestamp":1716791615000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["The <scp>Antiretroviral Pregnancy Registry<\/scp>: Three decades of prospective monitoring for birth defects"],"prefix":"10.1002","volume":"33","author":[{"given":"Jessica D.","family":"Albano","sequence":"first","affiliation":[{"name":"Real World &amp; Late Phase Syneos Health  Morrisville North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela E.","family":"Scheuerle","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Genetics and Metabolism University of Texas Southwestern  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Heather","family":"Watts","sequence":"additional","affiliation":[{"name":"Formerly of Office of the Global AIDS Coordinator and Health Diplomacy U.S. Department of State  Washington District of Columbia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen P.","family":"Beckerman","sequence":"additional","affiliation":[{"name":"Maternal Fetal Medicine, Zucker School of Medicine at Hofstra University Staten Island University Hospital  Staten Island New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne M.","family":"Mofenson","sequence":"additional","affiliation":[{"name":"Senior HIV Technical Advisor Elizabeth Glaser Pediatric AIDS Foundation  Washington District of Columbia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Pikis","sequence":"additional","affiliation":[{"name":"Division of Antivirals, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vani","family":"Vannappagari","sequence":"additional","affiliation":[{"name":"Epidemiology &amp; Real World Evidence ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Seekins","sequence":"additional","affiliation":[{"name":"Medical Safety Assessment \u2013 Immunology, Cardiovascular, Neuroscience Bristol\u2010Myers Squibb  Lawrenceville New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor S.","family":"Cook","sequence":"additional","affiliation":[{"name":"Real World &amp; Late Phase Syneos Health  Morrisville North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugh","family":"Tilson","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health University of North Carolina Chapel Hill  North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Antiretroviral Pregnancy Registry Steering Committee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,26]]},"reference":[{"key":"e_1_2_10_2_1","first-page":"91","volume-title":"AHRQ Publication No. 19(20)\u2010EHC020","author":"Albano J","year":"2020"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ogx.0000253377.14647.80"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.982"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.726"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.971"},{"key":"e_1_2_10_7_1","volume-title":"Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 through 31 January 2023","author":"Antiretroviral Pregnancy Registry Steering Committee","year":"2023"},{"issue":"1","key":"e_1_2_10_8_1","first-page":"1033","article-title":"Zidovudine exposure during pregnancy and hypospadias in infants: an analysis of data from the antiretroviral pregnancy registry, 1989\u20102014","volume":"4","author":"Albano JD","year":"2017","journal-title":"Clin Res HIV\/AIDS"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.10111"},{"key":"e_1_2_10_10_1","first-page":"65","article-title":"Metropolitan Atlanta congenital defects program 40th anniversary edition surveillance report: reporting birth defects surveillance data 1968\u20132003","volume":"79","author":"Correa A","year":"2007","journal-title":"Birth Defects Res (Part A)"},{"key":"e_1_2_10_11_1","volume-title":"Report of Birth Defects among 2000\u20132009 Deliveries. 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