Evidence map›Paper›PMID 27552003›Full record

ReviewExpert opinion on drug safety2016

Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges.

Rebecca M Zash, Paige L Williams, Jeanne Sibiude, Hermione Lyall, Fatima Kakkar

Registry-linked trialOpen access · greenAbstract readReview
In one paragraph

Review in Expert opinion on drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01310023 (Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01310023 completednot on this map

Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

TypeobservationalSponsorHarvard School of Public Health (HSPH)Ran2007 to 2025Enrolled5,169ConditionsAntiretroviral Toxicity
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 28 citations in OpenAlex.

  1. Article
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  10. Tenofovir alafenamide use in pregnant and lactating women living with HIV.Expert opinion on drug metabolism & toxicology · 2020
    Review
  11. Article
  12. Article
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  15. Article
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  18. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 5 countries.

Rebecca M Zasha Division of Infectious Diseases , Beth Israel Deaconess Medical Center , Boston , MA , USA.
Paige L Williamsd Center for Biostatistics in AIDS Research , Departments of Biostatistics and Epidemiology, Harvard T. H. Chan School of Public Health.
Jeanne Sibiudee Groupe Hospitalier Cochin Port Royal , Université Paris Descartes , Paris , France.
Hermione Lyallg Consultant Paediatrician, Infectious Diseases , Imperial College Healthcare NHS Trust , London , UK.
Fatima Kakkarh Division of Infectious Diseases , Centre Hospitalier Universtaire Sainte-Justine, University of Montreal , Sainte-Justine , Canada.
Botswana Harvard AIDS Institute Partnership · BWCancer Research And Biostatistics · USCentre de recherche en Epidémiologie et Santé des Populations · FRCentre Hospitalier Universitaire Sainte-Justine · CAImperial College Healthcare NHS Trust · GB

Funding

PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
Pediatric HIV/AIDS Cohort Study (PHACS): Understanding Maternal HIV Disease through Pregnancy and the Postpartum Period and its Role in Child Health OutcomesU01HD052104 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI VAN DYKE, RUSSELL B. · 2005 to 2019
$15.7M
PROGRAM FOR AIDS CLINICAL RESEARCH TRAINING (PACRT)T32AI007433 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MARK J SIEDNER · 1992 to 2026
$11.4M
NIAID NIH HHS T32 AI007433NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

introductionThe 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.

Indexed as

Anti-HIV AgentsFemaleHIV InfectionsHumansInfant, NewbornInfectious Disease Transmission, VerticalPregnancyPregnancy Complications, InfectiousRandomized Controlled Trials as TopicAnti-HIV Agentsantiretroviral therapyHIVinfant safetypregnancysurveillance programs

Identifiers

PMID27552003
PMCPMC5071158
OpenAlexW2512471366

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.