Evidence map›Paper›PMID 22030902›Full record

Trial reportHepatology (Baltimore, Md.)2012

Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial.

Gregory T Everson, Mitchell L Shiffman, John C Hoefs, Timothy R Morgan, Richard K Sterling, David A Wagner, Shannon Lauriski, Teresa M Curto, Anne Stoddard, Elizabeth C Wright and 1 more

4 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
2.4field-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.

NCT01579162 nacompletednot on this map

Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation

TypeinterventionalSponsorHepQuant, LLCRan2012 to 2015Enrolled48ConditionsHepatitis C, Chronic, Non-Alcoholic Fatty Liver DiseaseArmsCholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
NCT02523196 phase3completednot on this mapstarted 2016, after this paper: background citation

Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)

TypeinterventionalSponsorUniversity of Colorado, DenverRan2016 to 2017Enrolled20ConditionsLiver DiseaseArmsHepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate), Hepatic Venous Pressure Gradient (HVPG)
NCT06144827 nawithdrawnnot on this mapstarted 2025, after this paper: background citation

Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer

TypeinterventionalSponsorMontefiore Medical CenterRan2025 to 2028Enrolled0ConditionsCancer, Hepatocellular, Radiotherapy Side EffectArmsMultiparametric MRI scans, Multiparametric MRI scans + HepQuantShunt Test
NCT06899152 narecruitingnot on this mapstarted 2025, after this paper: background citation

HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer

TypeinterventionalSponsorMontefiore Medical CenterRan2025 to 2031Enrolled40ConditionsLiver Cancer, Hepatocellular Carcinoma, Hepatocellular Cancer, CholangiocarcinomaArmsHepQuant DuO, Multiparametric MRI Scans
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 76 citations in OpenAlex.

  1. Trial
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  4. Review
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  6. Observational
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  17. Review
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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

11 authors at 8 institutions in 1 country.

Gregory T EversonSection of Hepatology, Division of Gastroenterology and Hepatology, University of Colorado Denver, Aurora, CO 80045, USA. greg.everson@ucdenver.edu
Mitchell L Shiffman
John C Hoefs
Timothy R Morgan
Richard K Sterling
David A Wagner
Shannon Lauriski
Teresa M Curto
Anne Stoddard
Elizabeth C Wright
HALT-C Trial Group
New England Research Institutes · USUniversity of Colorado Denver · USBon Secours Health System · USMetabolic Solutions · USNational Institutes of Health · USUniversity of California, Irvine · USVA Long Beach Healthcare System · USVirginia Commonwealth University Medical Center · US

Funding

ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, R JEFFREY · 1985 to 2010
$74.3M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
X-LINKED HYPOPHOSPHATEMIAM01RR000065 · NCRR · VIRGINIA COMMONWEALTH UNIVERSITY · PI SANYAL, ARUN J · 1985 to 2010
$24.8M
HEPATITIS C CLINICAL TRIAL-DATA COORDINATING CENTER-267092328N01DK092328 · NIDDK · NEW ENGLAND RESEARCH INSTITUTES, INC. · 1999 to 2004
$1.5M
HEPATITIS C CLINICAL TRIAL- CLINICAL CENTERSN01DK092322 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI SHIFFMAN, MITCHELL L · 1999 to 2000
$699k
HEPATITIS C CLINICAL TRIALS- CLINICAL CENTERSN01DK092320 · NIDDK · UNIVERSITY OF CALIFORNIA IRVINE · PI HOEFS, JOHN C · 1999 to 2000
$627k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092327 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI EVERSON, GREGORY THOMAS · 1999 to 2000
$512k
NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR000065NCRR NIH HHS M01RR-00051NCRR NIH HHS M01RR-00065NCRR NIH HHS M01 RR000827NCRR NIH HHS M01RR-00827NIDDK NIH HHS N01 DK092327NIDDK NIH HHS N01-DK-9-2320NIDDK NIH HHS N01-DK-9-2322NIDDK NIH HHS N01-DK-9-2327NIDDK NIH HHS N01-DK-9-2328
6 · The paper itself

Abstract

unlabelledRisk for future clinical outcomes is proportional to the severity of liver disease in patients with chronic hepatitis C virus (HCV). We measured disease severity by quantitative liver function tests (QLFTs) to determine cutoffs for QLFTs that identified patients who were at low and high risk for a clinical outcome. Two hundred and twenty-seven participants in the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) Trial underwent baseline QLFTs and were followed for a median of 5.5 years for clinical outcomes. QLFTs were repeated in 196 patients at month 24 and in 165 patients at month 48. Caffeine elimination rate (k(elim)), antipyrine (AP) clearance (Cl), MEGX concentration, methionine breath test (MBT), galactose elimination capacity (GEC), dual cholate (CA) clearances and shunt, perfused hepatic mass (PHM), and liver and spleen volumes (by single-photon emission computed tomography) were measured. Baseline QLFTs were significantly worse (P = 0.0017 to P < 0.0001) and spleen volumes were larger (P < 0.0001) in the 54 patients who subsequently experienced clinical outcomes. QLFT cutoffs that characterized patients as "low" and "high risk" for clinical outcome yielded hazard ratios ranging from 2.21 (95% confidence interval [CI]: 1.29-3.78) for GEC to 6.52 (95% CI: 3.63-11.71) for CA clearance after oral administration (Cl(oral)). QLFTs independently predicted outcome in models with Ishak fibrosis score, platelet count, and standard laboratory tests. In serial studies, patients with high-risk results for CA Cl(oral) or PHM had a nearly 15-fold increase in risk for clinical outcome. Less than 5% of patients with "low risk" QLFTs experienced a clinical outcome.

conclusionQLFTs independently predict risk for future clinical outcomes. By improving risk assessment, QLFTs could enhance the noninvasive monitoring, counseling, and management of patients with chronic HCV.

Indexed as

Severity of Illness IndexAntiviral AgentsDrug Therapy, CombinationHepatitis C, ChronicHumansInterferon-alphaLiverLiver CirrhosisLiver Function TestsLongitudinal StudiesPolyethylene GlycolsPredictive Value of TestsProspective StudiesRecombinant ProteinsRetrospective StudiesRibavirinAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID22030902
PMCPMC3298578
OpenAlexW2113619397

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.