Evidence map›Paper›PMID 29315954›Full record

ArticleRapid communications in mass spectrometry : RCM2018

Development and validation of an assay to analyze atazanavir in human hair via liquid chromatography/tandem mass spectrometry.

Nhi Phung, Karen Kuncze, Hideaki Okochi, Alexander Louie, Leslie Z Benet, Igho Ofokotun, David W Haas, Judith S Currier, Tariro D Chawana, Anandi N Sheth and 3 more

Open access · greenAbstract readEvaluation Study
In one paragraph

Article in Rapid communications in mass spectrometry : RCM, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-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.

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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Measuring Adherence to Antiretroviral Therapy via Hair Concentrations in India.Journal of acquired immune deficiency syndromes (1999) · 2019
    Article
  7. Antiretroviral Concentrations in Hair Strongly Predict Virologic Response in a Large Human Immunodeficiency Virus Treatment-naive Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
  8. 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

13 authors at 5 institutions in 2 countries.

Nhi PhungDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.ORCID http://orcid.org/0000-0001-7165-0500
Karen KunczeDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.
Hideaki OkochiDepartment of Bioengineering and Therapeutic Sciences and Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.
Alexander LouieDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.
Leslie Z BenetDepartment of Bioengineering and Therapeutic Sciences and Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.
Igho OfokotunDivision of Infectious Diseases, Department of Medicine, Emory University, Atlanta, Georgia GA, USA; and Grady Healthcare System, Atlanta, Georgia GA, USA.
David W HaasDivision of Infectious Diseases, Department of Medicine, Vanderbilt School of Medicine and Department of Internal Medicine, Meharry Medical College, Nashville, TN, USA.
Judith S CurrierDivision of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA.
Tariro D ChawanaDepartment of Clinical Pharmacology, University of Zimbabwe, Harare, Zimbabwe.
Anandi N ShethDivision of Infectious Diseases, Department of Medicine, Emory University, Atlanta, Georgia GA, USA; and Grady Healthcare System, Atlanta, Georgia GA, USA.
Peter BacchettiDepartment of Epidemiology and Biostatistics, University of California, San Francisco (UCSF), San Francisco, CA, 94143, USA.
Monica GandhiDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.ORCID http://orcid.org/0000-0002-7025-1994
Howard HorngDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, 94143, USA.
University of California, San Francisco · USGrady Memorial Hospital · USMeharry Medical College · USUniversity of California, Los Angeles · USUniversity of Zimbabwe · ZW

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Jae M. Sevelius · 1988 to 2026
$93.6M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Ann M Chahroudi, Colleen F Kelley · 2002 to 2026
$74.0M
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
“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
Tel-Me-Box: Validating and testing a novel, low-cost, real-time monitoring device with hair level analysis among adherence-challenged patientsR01MH109310 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI EKSTRAND, MARIA L., GANDHI, MONICA · 2016 to 2020
$3.1M
Training for Research Excellence and MeNtorship in Tuberculosis (TRENT)D43TW009539 · FIC · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI METCALFE, JOHN ZAPATA · 2013 to 2022
$2.9M
Characterization and modulation of mucosal immunity for HIV prevention in womenK23AI114407 · NIAID · EMORY UNIVERSITY · PI SHETH, ANANDI NAYAN · 2014 to 2018
$898k
Hair measures to assess adherence and explain outcomes in an HIV clinical trialR21AI112362 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA · 2014 to 2015
$343k
FIC NIH HHS D43 TW009539NIAID NIH HHS K23 AI114407NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI050409NIAID NIH HHS R01 AI098472NIAID NIH HHS R21 AI112362NIAID NIH HHS R37 AI098472NIMH NIH HHS R01 MH109310
6 · The paper itself

Abstract

rationaleAssays to quantify antiretrovirals in hair samples are increasingly used to monitor adherence and exposure in both HIV prevention and treatment studies. Atazanavir (ATV) is a protease inhibitor used in combination antiretroviral therapy (ART). We developed and validated a liquid chromatography/tandem mass spectrometry (LC/MS/MS)-based method to quantify ATV in human hair, per the NIH Division of AIDS Clinical Pharmacology Quality Assurance (CPQA) program and the FDA bioanalytical method validation guidelines.

methodsATV was extracted from hair using optimized methods and the extracts were injected onto a BDS C-18 column (5 μm, 4.6 × 100 mm), followed by isocratic elution via a mobile phase composed of 55% acetonitrile, 45% water, 0.15% acetic acid, and 4 mM ammonium acetate, at a flow rate of 0.8 mL/min prior to analysis by MS/MS. Levels were quantified using positive electrospray ionization by multiple reaction monitoring (MRM) for the transitions MH

resultsOur assay demonstrated a linear standard curve (r = 0.99) over the concentration range of 0.0500 ng ATV/mg hair to 20.0 ng/mg hair. The inter- and intraday accuracy of ATV quality control (QC) samples was -1.33 to 4.00% and precision (% coefficient of variation (%CV)) was 1.75 to 6.31%. The %CV for ATV levels in hair samples from highly adherent patients (incurred samples) was less than 10%. No significant endogenous peaks or crosstalk were observed in the specificity test with other HIV drugs. The overall extraction efficiency of ATV from incurred hair samples was greater than 95%.

conclusionsThis highly sensitive, highly specific and validated assay can be considered for therapeutic drug monitoring for HIV-infected patients on ATV-based ART.

Indexed as

Anti-HIV AgentsAtazanavir SulfateChromatography, High Pressure LiquidHairHIV InfectionsHumansSpectrometry, Mass, Electrospray IonizationAnti-HIV AgentsAtazanavir Sulfate

Identifiers

PMID29315954
PMCPMC5848502
OpenAlexW2783361564

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Registered trials

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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.