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TOWARD EARLIER INCLUSION OF PREGNANT AND POSTPARTUM WOMEN IN TUBERCULOSIS DRUG TRIALS: CONSENSUS STATEMENTS FROM AN INTERNATIONAL EXPERT PANEL
Gupta, Amita et al. | Data do documento: 2016
Autor(es)
Gupta, Amita
Mathad, Jyoti S.
Abdel-Rahman, Susan M.
Albano, Jessica D.
Botgros, Radu
Brown, Vikki
Browning, Renee S.
Dawson, Liza
Dooley, Kelly E.
Gnanashanmugam, Devasena
Grinsztejn, Beatriz
Hernandez-Diaz, Sonia
Jean-Philippe, Patrick
Kim, Peter
Lyerly, Anne D.
Mirochnick, Mark
Mofenson, Lynne M.
Montepiedra, Grace
Piper, Jeanna
Sahin, Leyla
Savic, Radojka
Smith, Betsy
Spiegel, Hans
Swaminathan, Soumya
Watts, D. Heather
White, Amina
Afiliação
Johns Hopkins University. Division of Infectious Diseases and Department of International Health. USA.
Center for Global Health Weill Cornell Medical College. Division of Infectious Diseases. New York, USA.
Children's Mercy Hospital. Division of Clinical Pharmacology. Kansas City, Missouri, USA.
Post Approval & Strategic Services.
European Medicines Agency. London, United Kingdom.
INC Research. Women's Health and Medical Affairs. Raleigh, USA.
National Institute of Allergy and Infectious Diseases. Division of AIDS. USA.
National Institute of Allergy and Infectious Diseases. Division of AIDS. USA.
Johns Hopkins University School of Medicine. Divisions of Clinical Pharmacology and Infectious Diseases. Baltimore, USA.
National Institute of Allergy and Infectious Diseases. Division of AIDS. USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Department of Epidemiology.
Department of Health and Human Services, a division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, contractor to the National Institute of Allergy and Infectious Diseases.
National Institute of Allergy and Infectious Diseases. Division of AIDS. USA.
University of North Carolina at Chapel Hill Center for Bioethics and Department of Social Medicine.
Boston University School of Medicine. Department of Pediatrics. Massachusetts, USA.
National Institutes of Health. Eunice Kennedy Shriver National Institute of Child Health and Human Development. USA.
Harvard T. H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Department of Biostatistics. USA.
National Institute of Allergy and Infectious Diseases. Division of AIDS. USA.
FDA Office of New Drugs. Division of Pediatric and Maternal Health. Silver Spring, Maryland, USA.
University of California San Francisco. Schools of Pharmacy and Medicine. Department of Bioengineering and Therapeutic Sciences. USA.
National Institute of Allergy and Infectious Diseases. Division of AIDS. USA.
Department of Health and Human Services, a division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, contractor to the National Institute of Allergy and Infectious Diseases.
National Institute for Research in Tuberculosis. Chennai, India.
US Department of State. Office of the Global AIDS Coordinator. Washington D.C. USA.
NIH Clinical Center. Department of Bioethics. Bethesda.
Resumo em Inglês
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.
Palavras-chave em inglês
Tuberculosis
MDR tuberculosis
Latent tuberculosis infection
Pregnancy
Clinical trials
 
Referência
GUPTA, Amita et al. Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel. Clinical Infectious Diseases, v. 62, n. 6, p. 761–769, Mar. 2016.
DOI
10.1093/cid/civ991
ISSN
1058-4838