Evidence map›Paper›PMID 27191185›Full record

ArticlePloS one2016

Quantifying Isoniazid Levels in Small Hair Samples: A Novel Method for Assessing Adherence during the Treatment of Latent and Active Tuberculosis.

Roy Gerona, Anita Wen, Aaron T Chin, Catherine A Koss, Peter Bacchetti, John Metcalfe, Monica Gandhi

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05347823 (Study of Adherence to Antihypertensive Drugs and Statins in the Population of Subjects With Hypertension Followed at SIIA Centers, Using an Innovative Monitoring Based on Hair Analysis), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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.

NCT05347823 unknown statusnot on this mapstarted 2022, after this paper: background citation

Study of Adherence to Antihypertensive Drugs and Statins in the Population of Subjects With Hypertension Followed at SIIA Centers, Using an Innovative Monitoring Based on Hair Analysis

TypeobservationalSponsorAzienda Ospedaliera Universitaria Integrata VeronaRan2022 to 2023Enrolled200ConditionsArterial Hypertension, Dyslipidemias, Antihypertensive Drugs, StatinsArmsHair analysis for drug concentration
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

7 authors at 1 institution in 1 country.

Roy GeronaDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
Anita WenDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
Aaron T ChinDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
Catherine A KossDepartment of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
Peter BacchettiDepartment of Epidemiology and Biostatistics, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
John MetcalfeDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
Monica GandhiDepartment of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco (UCSF), San Francisco, CA, United States of America.
University of California, San Francisco · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Sheri Ann Lippman · 2001 to 2026
$57.4M
UCSF/Kaiser-DOR Program for Developing Independent Women's Health ResearchersK12HD052163 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ADLER, NANCY E, BRINDIS, CLAIRE D. · 2005 to 2023
$9.3M
Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention TrialsR01AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA · 2012 to 2021
$5.6M
Novel methods of pharmacologic monitoring for multidrug resistant tuberculosis treatment in the setting of HIV infectionR01AI123024 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA, METCALFE, JOHN ZAPATA · 2016 to 2020
$3.6M
“Hair Lengthening”: Using Hair Levels to Interpret Long-Acting PrEP Studies.R37AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2023 to 2026
$3.2M
NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI098472NIAID NIH HHS R01 AI123024NIAID NIH HHS R37 AI098472NICHD NIH HHS K12 HD052163NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundTuberculosis (TB) is the leading cause of death from an infectious pathogen worldwide and the most prevalent opportunistic infection in people living with HIV. Isoniazid preventive therapy (IPT) reduces the incidence of active TB and reduces morbidity and mortality in HIV-infected patients independently of antiretroviral therapy. However, treatment of latent or active TB is lengthy and inter-patient variability in pharmacokinetics and adherence common. Current methods of assessing adherence to TB treatment using drug levels in plasma or urine assess short-term exposure and pose logistical challenges. Drug concentrations in hair assess long-term exposure and have demonstrated pharmacodynamic relevance in HIV.

methodsA large hair sample from a patient with active TB was obtained for assay development. Methods to pulverize hair and extract isoniazid were optimized and then the drug detected by liquid chromatography/ tandem mass spectrometry (LC/MS-MS). The method was validated for specificity, accuracy, precision, recovery, linearity and stability to establish the assay's suitability for therapeutic drug monitoring (TDM). Hair samples from patients on directly-observe isoniazid-based latent or active TB therapy from the San Francisco Department of Public Health TB clinic were then tested.

resultsOur LC/MS-MS-based assay detected isoniazid in quantities as low as 0.02ng/mg using 10-25 strands hair. Concentrations in spiked samples demonstrated linearity from 0.05-50ng/mg. Assay precision and accuracy for spiked quality-control samples were high, with an overall recovery rate of 79.5%. In 18 patients with latent or active TB on treatment, isoniazid was detected across a wide linear dynamic range.

conclusionsAn LC-MS/MS-based assay to quantify isoniazid levels in hair with performance characteristics suitable for TDM was developed and validated. Hair concentrations of isoniazid assess long-term exposure and may be useful for monitoring adherence to latent or active TB treatment in the setting of HIV.

Indexed as

Patient ComplianceAdolescentAdultAgedAntitubercular AgentsFemaleGas Chromatography-Mass SpectrometryHairHumansIsoniazidLatent TuberculosisMaleMiddle AgedMolecular Diagnostic TechniquesSensitivity and SpecificityAntitubercular AgentsIsoniazid

Identifiers

PMID27191185
PMCPMC4871544
OpenAlexW2398978968

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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.