Evidence map›Paper›PMID 37735860›Full record

ArticleJournal of the International AIDS Society2023

Diagnostic accuracy of a point-of-care urine tenofovir assay, and associations with HIV viraemia and drug resistance among people receiving dolutegravir and efavirenz-based antiretroviral therapy.

Jienchi Dorward, Richard Lessells, Katya Govender, Pravi Moodley, Natasha Samsunder, Yukteshwar Sookrajh, Phil Turner, Christopher C Butler, Gail Hayward, Monica Gandhi and 2 more

Open access · goldAbstract read
In one paragraph

Article in Journal of the International AIDS Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

9 citing papers in PubMed, 11 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

12 authors at 7 institutions in 3 countries.

Jienchi DorwardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-6072-1430
Richard LessellsCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
Katya GovenderAfrica Health Research Institute, Durban, South Africa.
Pravi MoodleyDepartment of Virology, University of KwaZulu-Natal and National Health Laboratory Service, Inkosi Albert Luthuli Central Hospital, KwaZulu-Natal, South Africa.
Natasha SamsunderCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
Yukteshwar SookrajheThekwini Municipality Health Unit, Durban, South Africa.
Phil TurnerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Christopher C ButlerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Gail HaywardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Monica GandhiDivision of HIV, Infectious Disease, and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco, California, USA.ORCID 0000-0002-7025-1994
Paul K DrainDepartment of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-9569-4097
Nigel GarrettCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
Centre for the AIDS Programme of Research in South Africa · ZAUniversity of Oxford · GBAfrica Health Research Institute · ZAeThekwini Municipality · ZANational Health Laboratory Service · ZAUniversity of California, San Francisco · USUniversity of Washington · US

Funding

Department of HealthWellcome Trust 216421Wellcome Trust 216421/Z/19/Z
6 · The paper itself

Abstract

introductionNovel point-of-care assays which measure urine tenofovir (TFV) concentrations may have a role in improving adherence monitoring for people living with HIV (PLHIV) receiving antiretroviral therapy (ART). However, further studies of their diagnostic accuracy, and whether results are associated with viraemia and drug resistance, are needed to guide their use, particularly in the context of the global dolutegravir rollout.

methodsWe conducted a cross-sectional evaluation among PLHIV receiving first-line ART containing tenofovir disoproxil fumarate at enrolment into a randomized trial in two South African public sector clinics. We calculated the diagnostic accuracy of the Abbott point-of-care immunoassay to detect urine TFV compared to liquid chromatography-tandem mass spectrometry (LC-MS/MS). We evaluated the association between point-of-care urine TFV results and self-reported adherence, viraemia ≥1000 copies/ml and HIV drug resistance, among people receiving either efavirenz or dolutegravir-based ART.

resultsBetween August 2020 and March 2022, we enrolled 124 participants. The median age was 39 (IQR 34-45) years, 55% were women, 74 (59.7%) were receiving efavirenz and 50 (40.3%) dolutegravir. The sensitivity and specificity of the immunoassay to detect urine TFV ≥1500 ng/ml compared to LC-MS/MS were 96.1% (95% CI 90.0-98.8) and 95.2% (75.3-100.0), respectively. Urine TFV results were associated with short (p<0.001) and medium-term (p = 0.036) self-reported adherence. Overall, 44/124 (35.5%) had viraemia, which was associated with undetectable TFV in those receiving efavirenz (OR 6.01, 1.27-39.0, p = 0.014) and dolutegravir (OR 25.7, 4.20-294.8, p<0.001). However, in those with viraemia while receiving efavirenz, 8/27 (29.6%) had undetectable urine TFV, compared to 11/17 (64.7%) of those receiving dolutegravir. Drug resistance was detected in 23/27 (85.2%) of those receiving efavirenz and only 1/16 (6.3%) of those receiving dolutegravir. There was no association between urine TFV results and drug resistance.

conclusionsAmong PLHIV receiving ART, a rapid urine TFV immunoassay can be used to accurately monitor urine TFV levels compared to the gold standard of LC-MS/MS. Undetectable point-of-care urine TFV results were associated with viraemia, particularly among people receiving dolutegravir.

trial registrationPan-African Clinical Trials Registry: PACTR202001785886049.

Indexed as

HIV InfectionsAdultAlkynesBenzoxazinesChromatography, LiquidCross-Sectional StudiesCyclopropanesDolutegravirFemaleHumansMalePoint-of-Care SystemsTandem Mass SpectrometryTenofovirViremiaAlkynesBenzoxazinesCyclopropanesDolutegravirefavirenzTenofoviradherenceHIVpoint-of-caretenofovirurine assayviral failure

Identifiers

PMID37735860
PMCPMC10514373
OpenAlexW4386944795

What OpenQuestion holds

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LicenceCC BY
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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.