Evidence map›Paper›PMID 36181120›Full record

Trial reportMedicine2022

Isoniazid preventive therapy-related adverse events among Malawian adults on antiretroviral therapy: A cohort study.

Lufina Tsirizani-Galileya, Elasma Milanzi, Randy Mungwira, Titus Divala, Jane Mallewa, Donnie Mategula, Nginache Nampota, Victor Mwapasa, Andrea Buchwald, Matthew B Laurens and 2 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 35% 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.

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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

12 authors at 6 institutions in 4 countries.

Lufina Tsirizani-GalileyaBlantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.
Elasma MilanziMelbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Randy MungwiraBlantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.
Titus DivalaBlantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.
Jane MallewaDepartment of Medicine, Kamuzu University of Health Sciences, Blantyre, Malawi.
Donnie MategulaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Nginache NampotaBlantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.
Victor MwapasaSchool of Public Health and Family Medicine, Kamuzu University of Health Sciences, Blantyre, Malawi.
Andrea BuchwaldCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Matthew B LaurensCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Miriam K LauferCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Joep J Van OosterhoutDignitas International, Zomba, Malawi.ORCID 0000-0002-3441-0804
Kamuzu University of Health SciencesUniversity of Maryland, Baltimore · USKamuzu Central Hospital · MWThe University of Melbourne · AUUniversity of California, Los Angeles · USUniversity of Liverpool · GB

Funding

Clinical trial of trimethoprim-sulfamethoxazole or chloroquine in adults on ARTU01AI089342 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI LAUFER, MIRIAM K. · 2011 to 2017
$13.7M
NIAID NIH HHS U01 AI089342
6 · The paper itself

Abstract

Adverse events may be a cause of observed poor completion of isoniazid preventive therapy (IPT) among people living with HIV in high tuberculosis burden areas. Data on IPT-related adverse events (AE) from sub-Saharan Africa are scarce. We report IPT-related AEs, associated clinical characteristics, and IPT discontinuations in adults who were stable on antiretroviral therapy (ART) when they initiated IPT. Cohort study nested within a randomized, controlled, clinical trial of cotrimoxazole and chloroquine prophylaxis in Malawians aged ≥ 18 years and virologically suppressed on ART. Eight hundred sixty-nine patients were followed for a median of 6 months after IPT initiation. IPT relatedness of AEs was determined retrospectively with the World Health Organization case-causality tool. Frailty survival regression modeling identified factors associated with time to first probably IPT-related AE. The overall IPT-related AE incidence rate was 1.1/person year of observation. IPT relatedness was mostly uncertain and few AEs were severe. Most common were liver and hematological toxicities. Higher age increased risk of a probably IPT-related AE (aHR = 1.02; 95% CI 1.00-1.06; P = .06) and higher weight reduced this risk (aHR = 0.98; 95% CI 0.96-1.00; P = .03). Of 869 patients, 114 (13%) discontinued IPT and 94/114 (82%) discontinuations occurred at the time of a possibly or probably IPT-related AE. We observed a high incidence of mostly mild IPT-related AEs among individuals who were stable on ART. More than 1 in 8 persons discontinued IPT. These findings inform strategies to improve implementation of IPT in adults on ART, including close monitoring of groups at higher risk of IPT-related AEs.

Indexed as

HIV InfectionsIsoniazidAdultAntitubercular AgentsChloroquineCohort StudiesHumansRetrospective StudiesTrimethoprim, Sulfamethoxazole Drug CombinationAntitubercular AgentsChloroquineIsoniazidTrimethoprim, Sulfamethoxazole Drug Combination

Identifiers

PMID36181120
PMCPMC9524894
OpenAlexW4298126125

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.