Evidence map›Paper›PMID 26817634›Full record

Trial reportBMJ open2016

Can HIV reverse transcriptase activity assay be a low-cost alternative for viral load monitoring in resource-limited settings?

Soham Gupta, Riya Palchaudhuri, Ujjwal Neogi, Hiresave Srinivasa, Per Ashorn, Ayesha De Costa, Clas Källander, Anita Shet

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. 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
–field-weighted citation impact
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.

  1. 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

8 authors.

Soham GuptaDivision of Clinical Virology, Department of Microbiology, St. John's Medical College, Bangalore, India.
Riya PalchaudhuriDivision of Clinical Virology, Department of Microbiology, St. John's Medical College, Bangalore, India.
Ujjwal NeogiDivision of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
Hiresave SrinivasaDivision of Clinical Virology, Department of Microbiology, St. John's Medical College, Bangalore, India.
Per AshornDepartment for International Health, University of Tampere School of Medicine, Tampere, Finland.
Ayesha De CostaDepartment of Public Health Sciences, Karolinska Institute, Stockholm, Sweden.
Clas KällanderCavidi AB, Uppsala, Sweden.
Anita ShetDepartment of Pediatrics, St John's Medical College Hospital, Bangalore, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the performance and cost of an HIV reverse transcriptase-enzyme activity (HIV-RT) assay in comparison to an HIV-1 RNA assay for routine viral load monitoring in resource limited settings.

designA cohort-based longitudinal study.

settingTwo antiretroviral therapy (ART) centres in Karnataka state, South India, providing treatment under the Indian AIDS control programme.

participantsA cohort of 327 HIV-1-infected Indian adult patients initiating first-line ART. OUTCOME MEASURES: Performance and cost of an HIV-RT assay (ExaVir Load V3) in comparison to a gold standard HIV-1 RNA assay (Abbott m2000rt) in a cohort of 327 Indian patients before (WK00) and 4 weeks (WK04) after initiation of first-line therapy.

resultsPlasma viral load was determined by an HIV-1 RNA assay and an HIV-RT assay in 629 samples (302 paired samples and 25 single time point samples at WK00) obtained from 327 patients. Overall, a strong correlation of r=0.96 was observed, with good correlation at WK00 (r=0.84) and at WK04 (r=0.77). Bland-Altman analysis of all samples showed a good level of agreement with a mean difference (bias) of 0.22 log10copies/mL. The performance of ExaVir Load V3 was not negatively affected by a nevirapine/efavirenz based antiretroviral regimen. The per test cost of measuring plasma viral load by the Abbott m2000rt and ExaVir Load V3 assays in a basic lab setting was $36.4 and $16.8, respectively.

conclusionsThe strong correlation between the HIV-RT and HIV-1 RNA assays suggests that the HIV-RT assay can be an affordable alternative option for monitoring patients on antiretroviral therapy in resource-limited settings. TRIAL REGISTRATION NUMBER: ISRCTN79261738.

Indexed as

HIV-1Anti-HIV AgentsCosts and Cost AnalysisDrug Resistance, ViralDrug Therapy, CombinationEnzyme-Linked Immunosorbent AssayHIV InfectionsHIV Reverse TranscriptaseHumansIndiaLongitudinal StudiesMedically Underserved AreaPoint-of-Care SystemsReverse Transcriptase InhibitorsRNA, ViralViral LoadAnti-HIV AgentsHIV Reverse TranscriptaseReverse Transcriptase InhibitorsRNA, Viral

Identifiers

PMID26817634
PMCPMC4735141

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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.