{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:52:49Z","timestamp":1790704369655,"version":"4.1.0"},"reference-count":69,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,10,13]],"date-time":"2021-10-13T00:00:00Z","timestamp":1634083200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003323","name":"Agence Nationale de Recherches sur le Sida et les H\u00e9patites Virales","doi-asserted-by":"publisher","award":["12433 B112 AAP 2020\u20101"],"award-info":[{"award-number":["12433 B112 AAP 2020\u20101"]}],"id":[{"id":"10.13039\/501100003323","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>In 2018, 1.07 million pregnant women received antiretroviral drugs, raising whether this affects pregnancy outcomes. We assessed the adverse pregnancy outcomes associated with prenatal antiretroviral drug exposure, notified to the French ANRS pharmacovigilance system.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An exhaustive case report series has been performed using the ANRS pharmacovigilance database. All ANRS\u2010sponsored HIV clinical research studies using antiretroviral drugs either in pregnant women or women of childbearing age were eligible from 2004 to 2019. We analysed the following pregnancy outcomes: abortion, ectopic pregnancy, stillbirth, prematurity (&lt;37\u2009weeks of gestational age), low birth weight (&lt;2500\u2009g) and congenital abnormalities. A logistic regression was performed to assess the odds ratio (OR) for each outcome separately (if occurrence &gt;50) compared to the outcome observed when exposed to non\u2010nucleoside\u2010reverse\u2010transcriptase\u2010inhibitor (NNRTI)\u2010based regimen as the reference.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among the 34 studies selected, 918 deliveries occurred, of whom 88% had pregnancy outcomes documented. Pregnant women were mainly exposed to PI (<jats:italic>n<\/jats:italic>\u00a0=\u2009387, 48.6%), NNRTI (<jats:italic>n<\/jats:italic>\u00a0=\u2009331, 41.5%) and INI\u2010based combinations (<jats:italic>n<\/jats:italic>\u00a0=\u200940, 5.0%, 18 on dolutegravir). Compared to NNRTI\u2010based combinations, there was no significant association observed with exposure to other antiretroviral combination for spontaneous abortion, prematurity or low birth weight, except an increased risk of low birth weight in new\u2010born exposed to exclusive nucleoside\u2010reverse\u2010transcriptase\u2010inhibitor (NRTI) combinations (<jats:italic>n<\/jats:italic>\u00a0=\u00a04; OR 7.50 [1.49\u201337.83]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our study, mainly based on protease inhibitor (PI) and NNRTI\u2010based regimens, is overall reassuring on the risk of adverse pregnancy outcomes, except for NRTI which should be interpreted cautiously (small number, indication bias). In this study, the number of integrase inhibitor (INI)\u2010based combinations was too low to draw any conclusions.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15075","type":"journal-article","created":{"date-parts":[[2021,9,10]],"date-time":"2021-09-10T11:40:30Z","timestamp":1631274030000},"page":"942-964","source":"Crossref","is-referenced-by-count":8,"title":["In utero exposure to antiretroviral drugs and pregnancy outcomes: Analysis of the French ANRS pharmacovigilance database"],"prefix":"10.1111","volume":"88","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3069-4341","authenticated-orcid":false,"given":"Laura","family":"Saint\u2010Lary","sequence":"first","affiliation":[{"name":"CERPOP, Inserm, Universit\u00e9 de Toulouse, Universit\u00e9 Paul Sabatier III  Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alpha","family":"Diallo","sequence":"additional","affiliation":[{"name":"Clinical Trial Safety and Public Health ANRS  Paris 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