{
    "abstract": "Isoniazid preventive therapy (IPT) is recommended for tuberculosis prevention yet data on the safety of first-trimester pregnancy exposure are limited.\nPlanned secondary analysis in a TB prevention trial of adverse pregnancy outcomes among participants assigned to 9-month IPT who became pregnant during (IPT-exposed) or after (unexposed) IPT. Regression models compared binary outcomes of a composite adverse outcome (any non-live birth, excluding induced abortion); preterm delivery <37 weeks; and low birth weight <2500\u2005g) among exposure groups. Models were adjusted for latent TB infection, maternal age, CD4 count, and antiretroviral therapy (ART).\nIn total, 128 participants had a known pregnancy outcome; 39 IPT-exposed and 89 unexposed. At pregnancy outcome, ART use was lower in IPT-exposed (79%) than unexposed women (98%). Overall, 29 pregnancies ended in a composite adverse outcome (25 spontaneous abortions, 2 stillbirths and 2 ectopic pregnancies), 15 preterm deliveries, and 10 infants with low birth weight. IPT was associated with the composite adverse outcome adjusting for covariates at enrollment (adjusted relative risk [aRR] 1.98; 95% confidence interval [CI] 1.15, 3.41), but the effect was attenuated when adjusted for covariates at pregnancy outcome (aRR 1.47; 95% CI .84, 2.55); IPT was not associated with preterm delivery (relative risk [RR] 0.87; 95% CI .32-2.42) or low birth weight (RR 1.01; 95% CI .29, 3.56).\nFirst-trimester IPT exposure was associated with nearly two-fold increased risk of fetal demise, mostly spontaneous abortion, though the association was attenuated when adjusted for covariates proximal to pregnancy outcome including ART use. Further study is needed to inform TB prevention guidelines.",
    "authors": [
        {
            "affiliation": "Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.",
            "firstname": "Amita",
            "initials": "A",
            "lastname": "Gupta"
        },
        {
            "affiliation": "Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.",
            "firstname": "Michael D",
            "initials": "MD",
            "lastname": "Hughes"
        },
        {
            "affiliation": "Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.",
            "firstname": "Jorge Leon",
            "initials": "JL",
            "lastname": "Cruz"
        },
        {
            "affiliation": "HIV-NAT, Thai Red Cross AIDS Research Centre and Center of Excellence in Tuberculosis, Faculty of Medicine Chulalongkorn University, Bangkok, Thailand.",
            "firstname": "Anchalee",
            "initials": "A",
            "lastname": "Avihingsanon"
        },
        {
            "affiliation": "Department of Medicine, University of Witwatersrand, Johannesburg, South Africa.",
            "firstname": "Noluthando",
            "initials": "N",
            "lastname": "Mwelase"
        },
        {
            "affiliation": "Clinical Trials Unit, Les Centres GHESKIO, Port-au-Prince, Haiti.",
            "firstname": "Patrice",
            "initials": "P",
            "lastname": "Severe"
        },
        {
            "affiliation": "Botswana Harvard AIDS Institute Partnership, Clinical Trials Unit, Gaborone, Botswana.",
            "firstname": "Ayotunde",
            "initials": "A",
            "lastname": "Omoz-Oarhe"
        },
        {
            "affiliation": "Botswana Harvard AIDS Institute Partnership, Clinical Trials Unit, Gaborone, Botswana.",
            "firstname": "Gaerolwe",
            "initials": "G",
            "lastname": "Masheto"
        },
        {
            "affiliation": "Public Health and Scientific Research Unit, Social & Scientific Systems, a DLH Company, Silver Spring, Maryland, USA.",
            "firstname": "Laura",
            "initials": "L",
            "lastname": "Moran"
        },
        {
            "affiliation": "Division of Infectious Diseases, University of California San Diego School of Medicine, La Jolla, California, USA.",
            "firstname": "Constance A",
            "initials": "CA",
            "lastname": "Benson"
        },
        {
            "affiliation": "Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.",
            "firstname": "Richard E",
            "initials": "RE",
            "lastname": "Chaisson"
        },
        {
            "affiliation": "Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.",
            "firstname": "Susan",
            "initials": "S",
            "lastname": "Swindells"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.",
    "doi": "10.1093/cid/ciad583\n10.1128/microbiolspec.TNMI7-0016-2016",
    "journal": "Clinical infectious diseases : an official publication of the Infectious Diseases Society of America",
    "keywords": [
        "HIV infection",
        "TB preventive therapy",
        "adverse pregnancy outcome",
        "isoniazid",
        "pregnancy"
    ],
    "methods": null,
    "publication_date": "2023-09-28",
    "pubmed_id": "37768207\n30277688\n27862893\n26658057\n32217619\n35449551\n17578786\n28084207\n22942202\n25433626\n31577875\n32997744\n36969345\n30865794\n15033648\n31900473\n23533318\n29393655\n31631221\n31415563",
    "results": "In total, 128 participants had a known pregnancy outcome; 39 IPT-exposed and 89 unexposed. At pregnancy outcome, ART use was lower in IPT-exposed (79%) than unexposed women (98%). Overall, 29 pregnancies ended in a composite adverse outcome (25 spontaneous abortions, 2 stillbirths and 2 ectopic pregnancies), 15 preterm deliveries, and 10 infants with low birth weight. IPT was associated with the composite adverse outcome adjusting for covariates at enrollment (adjusted relative risk [aRR] 1.98; 95% confidence interval [CI] 1.15, 3.41), but the effect was attenuated when adjusted for covariates at pregnancy outcome (aRR 1.47; 95% CI .84, 2.55); IPT was not associated with preterm delivery (relative risk [RR] 0.87; 95% CI .32-2.42) or low birth weight (RR 1.01; 95% CI .29, 3.56).",
    "title": "Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester.",
    "xml": "<Element 'PubmedArticle' at 0x7885052ab060>"
}