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dc.rights.licenseopenen_US
dc.contributor.authorSAINT-LARY, Laura
dc.contributor.authorDIALLO, Alpha
dc.contributor.authorDE MONTEYNARD, Laure Amelie
dc.contributor.authorPAUL, Christelle
dc.contributor.authorMARCHAND, Lucie
dc.contributor.authorTUBIANA, Roland
dc.contributor.authorWARSZAWSKI, Josiane
dc.contributor.authorMANDELBROT, Laurent
dc.contributor.authorREKACEWICZ, Claire
dc.contributor.authorPETROV-SANCHEZ, Ventzislava
dc.contributor.authorFAYE, Albert
dc.contributor.authorSIBIUDE, Jeanne
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDABIS, Francois
dc.contributor.authorSOMMET, Agnes
dc.contributor.authorLEROY, Valeriane
dc.date.accessioned2021-11-15T10:51:17Z
dc.date.available2021-11-15T10:51:17Z
dc.date.issued2021-09-10
dc.identifier.issn1365-2125 (Electronic) 0306-5251 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/123797
dc.description.abstractEnAIMS: 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 drugs exposure, notified to the French ANRS pharmacovigilance system. METHODS: An exhaustive case report series has been performed using the ANRS pharmacovigilance database. All ANRS-sponsored 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 (<37 weeks of gestational age), low-birth-weight (<2500 grams) and congenital abnormalities. A logistic regression was performed to assess the Odds Ratio (OR) for each outcome separately (if occurrence >50) compared to the outcome observed when exposed to non-nucleoside-reverse-transcriptase-inhibitor (NNRTI)-based regimen as the reference. RESULTS: Among the 34 studies selected, 918 deliveries occurred, of whom 88% had pregnancy outcomes documented. Pregnant women were mainly exposed to PI (n=387, 48.6%), NNRTI (n=331, 41.5%) and INI-based combinations (n=40, 5.0%, 18 on dolutegravir). Compared to NNRTI-based 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-born exposed to exclusive nucleoside-reverse-transcriptase-inhibitor (NRTI) combinations (N=4; OR 7.50 [1.49-37.83]). CONCLUSIONS: Our study, mainly based on PI and NNRTI-based 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 INI-based combinations were too low to draw any conclusions.
dc.language.isoENen_US
dc.subject.enAdverse pregnancy outcomes
dc.subject.enANRS
dc.subject.enAntiretroviral drugs
dc.subject.enHIV
dc.subject.enPharmacovigilance
dc.title.enIn utero exposure to antiretroviral drugs and pregnancy outcomes: analysis of the French ANRS pharmacovigilance database
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/bcp.15075en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34505718en_US
bordeaux.journalBritish Journal of Clinical Pharmacologyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamIDLICen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03428753
hal.version1
hal.date.transferred2021-11-15T10:51:24Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=British%20Journal%20of%20Clinical%20Pharmacology&amp;rft.date=2021-09-10&amp;rft.eissn=1365-2125%20(Electronic)%200306-5251%20(Linking)&amp;rft.issn=1365-2125%20(Electronic)%200306-5251%20(Linking)&amp;rft.au=SAINT-LARY,%20Laura&amp;DIALLO,%20Alpha&amp;DE%20MONTEYNARD,%20Laure%20Amelie&amp;PAUL,%20Christelle&amp;MARCHAND,%20Lucie&amp;rft.genre=article


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