Evidence map›Paper›PMID 31900473›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Safety and Effectiveness of Isoniazid Preventive Therapy in Pregnant Women Living with Human Immunodeficiency Virus on Antiretroviral Therapy: An Observational Study Using Linked Population Data.

Emma Kalk, Alexa Heekes, Ushma Mehta, Renee de Waal, Nisha Jacob, Karen Cohen, Landon Myer, Mary-Ann Davies, Gary Maartens, Andrew Boulle

Abstract readObservational Study
In one paragraph

Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  6. Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Tuberculosis Preventive Treatment for Pregnant People With HIV in South Africa: A Modeling Analysis of Clinical Benefits and Risks.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  19. The effect of antenatal isoniazid preventive therapy on birth outcomes in Western Kenya.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Article
  20. Best practices for the care of pregnant people living with TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Review
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

10 authors.

Emma KalkCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Alexa HeekesCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Ushma MehtaCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Renee de WaalCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Nisha JacobDivision of Public Health Medicine, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Karen CohenDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Landon MyerCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Mary-Ann DaviesCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Gary MaartensWellcome Centre for Infectious Diseases Research in Africa, University of Cape Town, Cape Town, South Africa.
Andrew BoulleCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.

Funding

Observational Antiretroviral Studies In Southern Africa (OASIS) CollaborationU01AI069924 · NIAID · UNIVERSITAT BERN · PI Cleophas Chimbetete, Mary-Ann Davies · 2006 to 2026
$55.9M
B positive_A population based evaluation of expanded ART access in pregnancyR01HD080465 · NICHD · UNIVERSITY OF CAPE TOWN · PI KALK, EMMA KATE · 2014 to 2019
$4.3M
NIAID NIH HHS U01 AI069924NICHD NIH HHS R01 HD080465
6 · The paper itself

Abstract

backgroundIsoniazid preventive therapy (IPT) is widely used to protect against tuberculosis (TB) in people living with human immunodeficiency virus (HIV). Data on the safety and efficacy of IPT in pregnant women living with HIV (PWLHIV) are mixed. We used an individual-level, population-wide health database to examine associations between antenatal IPT exposure and adverse pregnancy outcomes, maternal TB, all-cause mortality, and liver injury during pregnancy through 12 months postpartum.

methodsWe used linked routine electronic health data generated in the public sector of the Western Cape, South Africa, to define a cohort of PWLHIV on antiretroviral therapy. Pregnancy outcomes were assessed using logistic regression; for maternal outcomes we applied a proportional hazards model with time-updated IPT exposure.

resultsOf 43 971 PWLHIV, 16.6% received IPT. Women who received IPT were less likely to experience poor pregnancy outcomes (adjusted odds ratio [aOR], 0.83 [95% confidence interval {CI}, .78-.87]); this association strengthened with IPT started after the first trimester compared with none (aOR, 0.71 [95% CI, .65-.79]) or with first-trimester exposure (aOR, 0.64 [95% CI, .55-.75]). IPT reduced the risk of TB by approximately 30% (aHR, 0.71 [95% CI, .63-.81]; absolute risk difference, 1518/100 000 women). The effect was modified by CD4 cell count with protection conferred if CD4 count was ≤350 cells/μL (aHR, 0.51 [95% CI, .41-.63]) vs 0.93 [95% CI, .76-1.13] for CD4 count >350 cells/µL).

conclusionsThis analysis of programmatic data is reassuring regarding the safety of antenatal IPT, with the greatest benefits against TB disease observed in women with CD4 count ≤350 cells/μL.

Indexed as

HIV InfectionsIsoniazidAntitubercular AgentsFemaleHIVHumansPregnancyPregnant PeopleSouth AfricaAntitubercular AgentsIsoniazidHIVisoniazid preventive therapypregnancy

Identifiers

PMID31900473
PMCPMC7643738

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.