Evidence map›Paper›PMID 29694825›Full record

ArticleThe New England journal of medicine2018

Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine.

Kathryn Rough, George R Seage, Paige L Williams, Sonia Hernandez-Diaz, Yanling Huo, Ellen G Chadwick, Judith S Currier, Risa M Hoffman, Emily Barr, David E Shapiro and 2 more

Registry-linked trialOpen access · bronzeAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in The New England journal of medicine, 2018. 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 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Antiretroviral Regimen and Pregnancy Outcomes of Women Living with HIV in a US Cohort.Infectious diseases in clinical practice (Baltimore, Md.) · 2023
    Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Viral Infections During Pregnancy: The Big Challenge Threatening Maternal and Fetal Health.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2022
    Article
  18. Review
  19. Article
  20. Article
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

12 authors at 6 institutions in 1 country.

Kathryn RoughFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
George R SeageFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Paige L WilliamsFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Sonia Hernandez-DiazFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Yanling HuoFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Ellen G ChadwickFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Judith S CurrierFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Risa M HoffmanFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Emily BarrFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
David E ShapiroFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
Kunjal PatelFrom the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of Colorado School of Medicine, Aurora (E.B.).
PHACS and the IMPAACT P1025 Study Teams
Harvard University · USUniversity of California, Los Angeles · USBrigham and Women's Hospital · USCancer Research And Biostatistics · USNorthwestern University · USUniversity of Colorado Denver · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
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 AI007433NIAID NIH HHS U01 AI068616NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

backgroundIn a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF-FTC-LPV/r) had infants at greater risk for very premature birth and death within 14 days after delivery than those assigned to receive zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV-3TC-LPV/r).

methodsUsing data from two U.S.-based cohort studies, we compared the risk of adverse birth outcomes among infants with in utero exposure to ZDV-3TC-LPV/r, TDF-FTC-LPV/r, or TDF-FTC with ritonavir-boosted atazanavir (ATV/r). We evaluated the risk of preterm birth (<37 completed weeks of gestation), very preterm birth (<34 completed weeks), low birth weight (<2500 g), and very low birth weight (<1500 g). Risk ratios with 95% confidence intervals were estimated with the use of modified Poisson models to adjust for confounding.

resultsThere were 4646 birth outcomes. Few infants or fetuses were exposed to TDF-FTC-LPV/r (128 [2.8%]) as the initial ART regimen during gestation, in contrast with TDF-FTC-ATV/r (539 [11.6%]) and ZDV-3TC-LPV/r (954 [20.5%]). As compared with women receiving ZDV-3TC-LPV/r, women receiving TDF-FTC-LPV/r had a similar risk of preterm birth (risk ratio, 0.90; 95% confidence interval [CI], 0.60 to 1.33) and low birth weight (risk ratio, 1.13; 95% CI, 0.78 to 1.64). As compared to women receiving TDF-FTC-ATV/r, women receiving TDF-FTC-LPV/r had a similar or slightly higher risk of preterm birth (risk ratio, 1.14; 95% CI, 0.75 to 1.72) and low birth weight (risk ratio, 1.45; 95% CI, 0.96 to 2.17). There were no significant differences between regimens in the risk of very preterm birth or very low birth weight.

conclusionsThe risk of adverse birth outcomes was not higher with TDF-FTC-LPV/r than with ZDV-3TC-LPV/r or TDF-FTC-ATV/r among HIV-infected women and their infants in the United States, although power was limited for some comparisons. (Funded by the National Institutes of Health and others.).

Indexed as

Infant, Low Birth WeightPregnancy OutcomeAdultAnti-HIV AgentsCohort StudiesDisease Transmission, InfectiousDrug Administration ScheduleDrug Therapy, CombinationEmtricitabineFemaleHIV InfectionsHumansInfant, NewbornLamivudineLopinavirPregnancyAnti-HIV AgentsEmtricitabineLamivudineLopinavirRitonavirTenofovirZidovudine

Identifiers

PMID29694825
PMCPMC5984044
OpenAlexW2803080648

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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.