Time for a Change: Optimizing Drug Data and Informed Choice in Pregnancy
Authors: Andrea Ciaranello, Angela Mushavi, Shahin Lockman
Journal: Annals of Internal Medicine (2021)

EditorialsJanuary 2022Time for a Change: Optimizing Drug Data and Informed Choice in PregnancyAndrea Ciaranello, MD, MPH, Angela Mushavi, MBChB, MMed, Shahin Lockman, MD, MScAndrea Ciaranello, MD, MPHDivision of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard University Center for AIDS Research, and Harvard Medical School, Boston, MassachusettsSearch for more papers by this author, Angela Mushavi, MBChB, MMedMinistry of Health and Child Care in Zimbabwe, Harare, ZimbabweSearch for more papers by this author, Shahin Lockman, MD, MScDivision of Infectious Diseases, Brigham and Women's Hospital, Department of Immunology and Infectious Disease, Harvard T.H. Chan School of Public Health, and Botswana Harvard AIDS Institute Partnership, Boston, MassachusettsSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M21-4338 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Romo and colleagues (1) provide a poignant example of how far we remain from prioritizing women's decision-making autonomy and health and from having timely, high-quality data for drugs used during pregnancy and breastfeeding.The global rollout of dolutegravir—a well-tolerated, highly effective antiretroviral medication—for treating all adults and adolescents with HIV was abruptly halted for women in May 2018. This followed an unexpected report from Botswana of higher risk for neural tube defects in women conceiving while receiving dolutegravir treatment, which led the World Health Organization to recommend HIV treatment regimens that did not contain dolutegravir for women who may become ...References1. Romo ML, Patel RC, Edwards JK, et al. Disparities in dolutegravir uptake affecting females of reproductive age with HIV in low- and middle-income countries after initial concerns about teratogenicity. An observational study. Ann Intern Med. 2022;175:84-94. doi:10.7326/M21-3037 Google Scholar2. Zash R, Holmes L, Diseko M, et al. Neural-tube defects and antiretroviral treatment regimens in Botswana. N Engl J Med. 2019;381:827-840. [PMID: 31329379] doi:10.1056/NEJMoa1905230 CrossrefMedlineGoogle Scholar3. Myer L. Modeling the benefits and harms of DTG use in pregnancy. Presented at IAS 2019, Mexico City, Mexico, 21 July 2019. Accessed at https://programme.ias2019.org/Programme/Session/154 on 5 November 2021. Google Scholar4. Lockman S, Brummel SS, Ziemba L, et al; IMPAACT 2010/VESTED Study Team and Investigators. Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2021;397:1276-1292. [PMID: 33812487] doi:10.1016/S0140-6736(21)00314-7 CrossrefMedlineGoogle Scholar5. Chinula L, Brummel S, Ziemba L, et al. Safety/efficacy of DTG vs EFV, TDF vs TAF in pregnancy/postpartum: IMPAACT 2010 Trial. Presented at CROI 2021, virtual, 10 March 2021. Accessed at www.croiconference.org/abstract/safety-efficacy-of-dtg-vs-efv-tdf-vs-taf-in-pregnancy-postpartum-impaact-2010-trial/ on 5 November 2021. Google Scholar6. Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011;157C:175-82. [PMID: 21766440] doi:10.1002/ajmg.c.30313 CrossrefMedlineGoogle Scholar7. Smith DD, Pippen JL, Adesomo AA, et al. Exclusion of pregnant women from clinical trials during the coronavirus disease 2019 pandemic: a review of international registries. Am J Perinatol. 2020;37:792-799. [PMID: 32428965] doi:10.1055/s-0040-1712103 CrossrefMedlineGoogle Scholar8. Antiretroviral Pregnancy Registry. The Antiretroviral Pregnancy Registry. Accessed at www.apregistry.com/Default.aspx on 3 November 2021. Google Scholar9. Lampe MA, Wiener J, Reefhuis J, et al. Estimates of periconceptual exposures to integrase inhibitors, United States. Presented at CROI 2020, Boston, Massachusetts, 8–11 March 2020. Accessed at www.croiconference.org/abstract/estimates-of-periconceptional-exposures-to-integrase-inhibitors-united-states/ on 5 November 2021. Google Scholar10. Little MO, Wickremsinhe MN. Research with pregnant women: a call to action. Reprod Health. 2017;14:156. [PMID: 29297373] doi:10.1186/s12978-017-0419-x CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Division of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard University Center for AIDS Research, and Harvard Medical School, Boston, MassachusettsMinistry of Health and Child Care in Zimbabwe, Harare, ZimbabweDivision of Infectious Diseases, Brigham and Women's Hospital, Department of Immunology and Infectious Disease, Harvard T.H. Chan School of Public Health, and Botswana Harvard AIDS Institute Partnership, Boston, MassachusettsAcknowledgment: The authors thank Elena Y. Jin for assistance with manuscript preparation.Disclosures: Authors have reported no disclosures of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M21-4338.Corresponding Author: Andrea Ciaranello, MD, MPH, Massachusetts General Hospital, 100 Cambridge Street, Room 1670, Boston, MA 02114; e-mail, [email protected]harvard.edu.This article was published at Annals.org on 30 November 2021. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoDisparities in Dolutegravir Uptake Affecting Females of Reproductive Age With HIV in Low- and Middle-Income Countries After Initial Concerns About Teratogenicity Matthew L. Romo , Rena C. Patel , Jessie K. Edwards , John M. Humphrey , Beverly S. Musick , Caitlin Bernard , Mercy W. Maina , Ellen Brazier , Barbara Castelnuovo , Jeremy Penner , Katarzyna Wyka , Sandra Wagner Cardoso , Penh Sun Ly , Cordelia Kunzekwenyika , Claudia P. Cortés , Radoslaw Panczak , Elizabeth A. Kelvin , Kara K. Wools-Kaloustian , Denis Nash , and Metrics January 2022Volume 175, Issue 1Page: 133-134KeywordsAge groupsAntiretroviral therapyContraceptivesHIVHealth equityPregnancyPrevention, policy, and public healthSafety ePublished: 30 November 2021 Issue Published: January 2022 Copyright & PermissionsCopyright © 2021 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...