Evidence map›Paper›PMID 27762283›Full record

ArticleScientific reports2016

Hepatitis C RNA assay differences in results: Potential implications for shortened therapy and determination of Sustained Virologic Response.

Gavin Cloherty, Stephane Chevaliez, Christoph Sarrazin, Christine Herman, Vera Holzmayer, George Dawson, Benjamin Maasoumy, Johannes Vermehren, Heiner Wedemeyer, Jordan J Feld and 1 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
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 4 countries.

Gavin ClohertyAbbott Laboratories, Abbott Park, IL, USA.
Stephane ChevaliezNational Reference Center for Viral Hepatitis B, C and delta, Hopital Henry Mondor, Université Paris-Est, Créteil, France.
Christoph SarrazinMedizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
Christine HermanAbbott Laboratories, Abbott Park, IL, USA.
Vera HolzmayerAbbott Laboratories, Abbott Park, IL, USA.
George DawsonAbbott Laboratories, Abbott Park, IL, USA.
Benjamin MaasoumyKlinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, Germany.
Johannes VermehrenKlinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, Germany.
Heiner WedemeyerMedizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
Jordan J FeldToronto Centre for Liver Disease, Sandra Rotman Centre for Global Health, University of Toronto, Toronto, ON, Canada.
Jean-Michel PawlotskyNational Reference Center for Viral Hepatitis B, C and delta, Hopital Henry Mondor, Université Paris-Est, Créteil, France.
Abbott Fund · USMedizinische Hochschule Hannover · DEUniversité Paris-Est Créteil · FRGoethe University Frankfurt · DEUniversity Hospital Frankfurt · DEUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Approval of Ledipasvir/Sofosbuvir for the treatment of chronic hepatitis C (HCV) includes the truncation of therapy from 12 to 8 weeks in treatment naïve, non-cirrhotic patients with baseline HCV RNA levels <6 million IU/mL (6.8 log10 IU/mL). The aim of this study was to evaluate this clinical cutoff with a different widely used commercially available HCV RNA test. Results from samples tested prospectively with Roche High Pure TaqMan HCV 2.0 test (HPS) were compared to those tested retrospectively with the Abbott RealTime HCV RNA test (ART). Using 6 million IU/mL as the cut-off, pre-treatment results were concordant in 70.4% of cases. When results with the same test measured at screening and baseline, clinical decisions could be impacted in 14.4% and 6.2% of cases for HPS and ART respectively. Using only HCV RNA cutoff of 6 million IU/mL, 29.55% of subjects would receive a different and potentially incorrect treatment duration based solely on HCV RNA test method used. A further 6-14% of subjects would have treatment decision change based on the day the sample was taken.

Indexed as

RNA, ViralAntiviral AgentsGenotypeHepacivirusHepatitis C, ChronicHumansMolecular Diagnostic TechniquesReal-Time Polymerase Chain ReactionROC CurveSensitivity and SpecificityViral LoadAntiviral AgentsRNA, Viral

Identifiers

PMID27762283
PMCPMC5071881
OpenAlexW2532318579

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.