Evidence map›Paper›PMID 36815322›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Symptoms and Systemic Drug Reactions in Persons Receiving Weekly Rifapentine Plus Isoniazid (3HP) Treatment for Latent Tuberculosis Infection.

Claire Sadowski, Robert Belknap, David P Holland, Ruth N Moro, Michael P Chen, Alicia Wright, Joan Pau Millet, Joan A Caylà, Nigel A Scott, Andrey Borisov and 1 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01582711 (TBTC Study 33. An Evaluation of Adherence to Latent Tuberculosis Infection), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT01582711 phase3completednot on this map

TBTC Study 33. An Evaluation of Adherence to Latent Tuberculosis Infection (LTBI) Treatment With 12 Doses of Once Weekly Rifapentine (RPT) and Isoniazid (INH) Given as Self-administered (SAT) Versus Directly-observed Therapy (DOT): iAdhere.

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2012 to 2014Enrolled1,002ConditionsLatent Tuberculosis InfectionArmsSelf Administered Therapy (SAT), SMS reminders, isoniazid and rifapentine
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Tuberculosis: An Update for the Clinician.Respirology (Carlton, Vic.) · 2025
    Review
  8. Historical and Social Considerations upon Tuberculosis.Journal of preventive medicine and hygiene · 2025
    Article
  9. Treatment completion rates and adverse effects of three months of once-weekly isoniazid plus rifapentine for latent tuberculosis infection.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2025
    Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Latent TB treatment regimens in 2023: Wetmore TB clinic in New Orleans.Journal of clinical tuberculosis and other mycobacterial diseases · 2024
    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

11 authors at 6 institutions in 2 countries.

Claire SadowskiDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.ORCID 0000-0001-8356-2145
Robert BelknapDenver Metro Tuberculosis Program, Denver Public Health, Denver, Colorado, USA.
David P HollandDepartment of Medicine, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
Ruth N MoroCDC Foundation, Research Collaboration, Atlanta, Georgia, USA.
Michael P ChenImmunization Services Division, National Center for Immunization and Respiratory Diseases (NCIRD), US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Alicia WrightDivision of Infectious Diseases, Vanderbilt University Medical Centers, Nashville, Tennessee, USA.
Joan Pau MilletEpidemiology Service, Public Health Agency of Barcelona, Barcelona, Spain.
Joan A CaylàFoundation of Tuberculosis Research Unit of Barcelona, Barcelona, Spain.
Nigel A ScottClinical Research Branch, Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Andrey BorisovClinical Research Branch, Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Neel R GandhiDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
Centers for Disease Control and Prevention · USEmory University · USCentro de Investigación Biomédica en Red de Epidemiología y Salud Pública · ESDenver Public Health · USOak Ridge Associated Universities · USVanderbilt University Medical Center · US

Funding

Emory/Georgia TB Research Advancement Center (TRAC)P30AI168386 · NIAID · EMORY UNIVERSITY · PI Neel Rajnikant Gandhi · 2022 to 2026
$5.8M
Mentorship in Patient-Oriented Research in Tuberculosis, HIV and Global HealthK24AI114444 · NIAID · EMORY UNIVERSITY · PI GANDHI, NEEL RAJNIKANT · 2014 to 2023
$1.8M
NIAID NIH HHS K24 AI114444NIAID NIH HHS P30 AI168386
6 · The paper itself

Abstract

backgroundThree months of weekly rifapentine plus isoniazid (3HP) therapy for latent tuberculosis infection (LTBI) is recommended worldwide. The development of symptoms and systemic drug reactions (SDRs) on 3HP have not been fully characterized. We aimed to determine the patterns of symptom development and identify SDRs and associated factors in patients taking 3HP.

methodsWe analyzed symptoms data in participants receiving 3HP in the Tuberculosis Trials Consortium's iAdhere study (Study 33). We examined the patterns of symptom reporting across participants from baseline and 4 monthly visits. Bivariate analyses and multivariable regression models were used to identify factors associated with SDRs. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated.

resultsAmong 1002 participants receiving 3HP, 768 (77%) reported at least 1 symptom; 97% of these symptoms were grade 1 (79%) or grade 2 (18%). Most symptoms developed in the first month and resolved. A total of 111 (11%) participants had symptoms that met criteria for SDRs; however, 53 (48%) of these participants completed therapy. Factors associated with SDRs and discontinuation included female sex (RR: 2.05; 95% CI: 1.19-3.54), age ≥45 years (RR: 1.99; 95% CI: 1.19-3.31), and use of concomitant medications (RR: 2.26; 95% CI: 1.15-4.42).

conclusionsAlthough most patients receiving 3HP reported symptoms, most were mild, occurred early, and resolved without stopping treatment. Among patients experiencing SDRs, nearly half were able to complete therapy. Patient and provider education should focus on differentiating severe reactions where 3HP should be stopped from minor symptoms that will resolve. Clinical Trials Registration. NCT01582711.

Indexed as

Drug-Related Side Effects and Adverse ReactionsLatent TuberculosisAntitubercular AgentsDrug Therapy, CombinationFemaleHumansIsoniazidMiddle AgedRifampinAntitubercular AgentsIsoniazidRifampinrifapentine3HPlatent tuberculosis treatment

Identifiers

PMID36815322
PMCPMC10273365
OpenAlexW4321612575

What OpenQuestion holds

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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.