title: Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel.
abstract: Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15-44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum women in tuberculosis drug trials, the US National Institutes of Health convened an international expert panel. Discussions generated consensus statements (>75% agreement among panelists) identifying high-priority research areas during pregnancy, including: (1) preventing progression of latent tuberculosis infection, especially in women coinfected with human immunodeficiency virus; (2) evaluating new agents/regimens for treatment of multidrug-resistant tuberculosis; and (3) evaluating safety, tolerability and pharmacokinetics of tuberculosis drugs already in use during pregnancy and postpartum. Incorporating pregnant women into clinical trials would extend evidence-based tuberculosis prevention and treatment standards to this special population.
authors.affiliation: Division of Infectious Diseases and Department of International Health, Johns Hopkins University.
authors.forename: Amita
authors.initials: A
authors.lastname: Gupta
authors.affiliation: Division of Infectious Diseases, Center for Global Health Weill Cornell Medical College, New York, New York.
authors.forename: Jyoti S
authors.initials: JS
authors.lastname: Mathad
authors.affiliation: Division of Clinical Pharmacology, Children's Mercy Hospital, Kansas City, Missouri.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Abdel-Rahman
authors.affiliation: Post Approval & Strategic Services.
authors.forename: Jessica D
authors.initials: JD
authors.lastname: Albano
authors.affiliation: European Medicines Agency, London, United Kingdom.
authors.forename: Radu
authors.initials: R
authors.lastname: Botgros
authors.affiliation: Women's Health and Medical Affairs, INC Research, Raleigh.
authors.forename: Vikki
authors.initials: V
authors.lastname: Brown
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases.
authors.forename: Renee S
authors.initials: RS
authors.lastname: Browning
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases.
authors.forename: Liza
authors.initials: L
authors.lastname: Dawson
authors.affiliation: Divisions of Clinical Pharmacology and Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore.
authors.forename: Kelly E
authors.initials: KE
authors.lastname: Dooley
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases.
authors.forename: Devasena
authors.initials: D
authors.lastname: Gnanashanmugam
authors.affiliation: Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Grinsztejn
authors.affiliation: Department of Epidemiology.
authors.forename: Sonia
authors.initials: S
authors.lastname: Hernandez-Diaz
authors.affiliation: Department of Health and Human Services, HJF-DAIDS, a division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, contractor to the National Institute of Allergy and Infectious Diseases.
authors.forename: Patrick
authors.initials: P
authors.lastname: Jean-Philippe
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases.
authors.forename: Peter
authors.initials: P
authors.lastname: Kim
authors.affiliation: University of North Carolina at Chapel Hill Center for Bioethics and Department of Social Medicine.
authors.forename: Anne D
authors.initials: AD
authors.lastname: Lyerly
authors.affiliation: Department of Pediatrics, Boston University School of Medicine, Massachusetts.
authors.forename: Mark
authors.initials: M
authors.lastname: Mirochnick
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health.
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.affiliation: Department of Biostatistics, Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health.
authors.forename: Grace
authors.initials: G
authors.lastname: Montepiedra
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases.
authors.forename: Jeanna
authors.initials: J
authors.lastname: Piper
authors.affiliation: Division of Pediatric and Maternal Health, FDA Office of New Drugs, Silver Spring, Maryland.
authors.forename: Leyla
authors.initials: L
authors.lastname: Sahin
authors.affiliation: Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco.
authors.forename: Radojka
authors.initials: R
authors.lastname: Savic
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases.
authors.forename: Betsy
authors.initials: B
authors.lastname: Smith
authors.affiliation: Department of Health and Human Services, HJF-DAIDS, a division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, contractor to the National Institute of Allergy and Infectious Diseases.
authors.forename: Hans
authors.initials: H
authors.lastname: Spiegel
authors.affiliation: National Institute for Research in Tuberculosis, Chennai, India.
authors.forename: Soumya
authors.initials: S
authors.lastname: Swaminathan
authors.affiliation: Office of the Global AIDS Coordinator, US Department of State, Washington D.C.
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda.
authors.forename: Amina
authors.initials: A
authors.lastname: White
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D055985:Latent Tuberculosis / Q000097:blood / Q000188:drug therapy* / Q000382:microbiology; D049590:Postpartum Period; D011247:Pregnancy; D014376:Tuberculosis / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control*; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy / Q000382:microbiology / Q000517:prevention & control*; D014481:United States
chemical_list: D000995:Antitubercular Agents
keywords: MDR tuberculosis; clinical trials; latent tuberculosis infection; pregnancy; tuberculosis