title: Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges.
abstract: The use of antiretroviral therapy (ART) in pregnancy to prevent vertical HIV transmission has been one of the most successful public health programs in the last decade. As a result, an unprecedented number of women are taking ART at conception and during pregnancy. Given few randomized studies evaluating safety of different ART regimens in pregnancy, ongoing drug safety surveillance is critical. Areas covered: This review aims to provide a rationale for ART drug safety surveillance, describe changing patterns of ART use and summarize current surveillance efforts in both low-resource and high-resource settings. Additionally, biostatistical approaches to and challenges in analysis of observational surveillance data are discussed. Expert opinion: The global landscape of ART use in pregnancy is rapidly increasing and evolving. Any increase in adverse effects of in-utero exposure to ART has the potential to reduce the impact of improvements in infant morbidity and mortality gained from decreased vertical HIV transmission. ART drug safety surveillance should therefore be a critical piece of programs to prevent mother to child transmission in both high- and low-resource settings. Current surveillance efforts could be strengthened with long-term follow-up of exposed children, pooling of data across cohorts and standardized approaches to analysis.
authors.affiliation: a Division of Infectious Diseases , Beth Israel Deaconess Medical Center , Boston , MA , USA.|b Department of Immunology and Infectious Diseases , Harvard T. H. Chan School of Public Health , Boston , MA , USA.|c Botswana Harvard AIDS Institute Partnership , Gaborone , Botswana.
authors.forename: Rebecca M
authors.initials: RM
authors.lastname: Zash
authors.affiliation: d Center for Biostatistics in AIDS Research , Departments of Biostatistics and Epidemiology, Harvard T. H. Chan School of Public Health.
authors.forename: Paige L
authors.initials: PL
authors.lastname: Williams
authors.affiliation: e Groupe Hospitalier Cochin Port Royal , Université Paris Descartes , Paris , France.|f INSERM CESP 1018 , Le Kremlin Bicêtre , France.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Sibiude
authors.affiliation: g Consultant Paediatrician, Infectious Diseases , Imperial College Healthcare NHS Trust , London , UK.
authors.forename: Hermione
authors.initials: H
authors.lastname: Lyall
authors.affiliation: h Division of Infectious Diseases , Centre Hospitalier Universtaire Sainte-Justine, University of Montreal , Sainte-Justine , Canada.
authors.forename: Fatima
authors.initials: F
authors.lastname: Kakkar
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000821:virology; D016032:Randomized Controlled Trials as Topic
chemical_list: D019380:Anti-HIV Agents
keywords: HIV; antiretroviral therapy; infant safety; pregnancy; surveillance programs