Evidence map›Paper›PMID 22688849›Full record

Trial reportThe American journal of gastroenterology2012

Reduction in Hepatic Inflammation Is Associated With Less Fibrosis Progression and Fewer Clinical Outcomes in Advanced Hepatitis C.

Chihiro Morishima, Mitchell L Shiffman, Jules L Dienstag, Karen L Lindsay, Gyongyi Szabo, Gregory T Everson, Anna S Lok, Adrian M Di Bisceglie, Marc G Ghany, Deepa Naishadham and 3 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The American journal of gastroenterology, 2012. 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
1.0field-weighted citation impact, top 24% 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, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Review
  8. 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

13 authors at 11 institutions in 2 countries.

Chihiro MorishimaDepartment of Laboratory Medicine, University of Washington, Seattle, Washington, USA. chihiro@u.washington.edu
Mitchell L Shiffman
Jules L Dienstag
Karen L Lindsay
Gyongyi Szabo
Gregory T Everson
Anna S Lok
Adrian M Di Bisceglie
Marc G Ghany
Deepa Naishadham
Timothy R Morgan
Elizabeth C Wright
HALT-C Trial Group
University of Washington · USBon Secours Health System · USDepartment of Health and Human Services · USHarvard University · USNew England Research Institutes · USSaint Louis University · USUniversity of California, Irvine · USUniversity of Colorado Denver · USUniversity of Massachusetts Chan Medical School · USUniversity of Michigan–Ann Arbor · USUniversity of Southern California · US

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ZAIA, JOHN A · 1985 to 2010
$76.4M
ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, R JEFFREY · 1985 to 2010
$74.3M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RUBENFIRE, MELVYN · 1985 to 2007
$40.8M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI BROWN, EMERY N · 1985 to 2008
$37.4M
NORTH AND CENTRAL TEXAS CTSA FOR PEDIATRIC RESEARCHUL1RR024982 · NCRR · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2007 to 2011
$27.9M
X-LINKED HYPOPHOSPHATEMIAM01RR000065 · NCRR · VIRGINIA COMMONWEALTH UNIVERSITY · PI SANYAL, ARUN J · 1985 to 2010
$24.8M
ZONISAMIDE VERSUS PLACEBOM01RR006192 · NCRR · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI DRAZINIC, CAROLYN M · 1994 to 2008
$22.1M
XU 40468 IN HYPERCHOLESTEROLEMIAM01RR000633 · NCRR · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 1985 to 2007
$21.0M
NCATS NIH HHS UL1 TR000451NCRR NIH HHS 1 UL1RR024982-01NCRR NIH HHS 1 UL1 RR024986NCRR NIH HHS 1 UL1 RR025758-01NCRR NIH HHS M01 RR000042NCRR NIH HHS M01 RR000043NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR000065NCRR NIH HHS M01RR-00042NCRR NIH HHS M01RR-00043NCRR NIH HHS M01RR-00051NCRR NIH HHS M01 RR000633NCRR NIH HHS M01RR-00065NCRR NIH HHS M01 RR000827NCRR NIH HHS M01 RR001066NCRR NIH HHS M01 RR006192NCRR NIH HHS M01RR-00633NCRR NIH HHS M01RR-00827NCRR NIH HHS M01RR-01066NCRR NIH HHS M01RR-06192NCRR NIH HHS UL1 RR024982NCRR NIH HHS UL1 RR024986NCRR NIH HHS UL1 RR025758NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1 RR 025780-01NIDDK NIH HHS N01 DK092318NIDDK NIH HHS N01 DK092319NIDDK NIH HHS N01 DK092320NIDDK NIH HHS N01 DK092321NIDDK NIH HHS N01 DK092322NIDDK NIH HHS N01 DK092323NIDDK NIH HHS N01 DK092324NIDDK NIH HHS N01 DK092325NIDDK NIH HHS N01 DK092326NIDDK NIH HHS N01 DK092327NIDDK NIH HHS N01 DK092328NIDDK NIH HHS N01-DK-9-2318NIDDK NIH HHS N01-DK-9-2319NIDDK NIH HHS N01-DK-9-2320NIDDK NIH HHS N01-DK-9-2321NIDDK NIH HHS N01-DK-9-2322NIDDK NIH HHS N01-DK-9-2323NIDDK NIH HHS N01-DK-9-2324NIDDK NIH HHS N01-DK-9-2325NIDDK NIH HHS N01-DK-9-2326NIDDK NIH HHS N01-DK-9-2327NIDDK NIH HHS N01-DK-9-2328NIDDK NIH HHS U01 DK082871
6 · The paper itself

Abstract

objectivesDuring the Hepatitis C Antiviral Long-term Treatment against Cirrhosis Trial, 3.5 years of maintenance peginterferon-alfa-2a therapy did not affect liver fibrosis progression or clinical outcomes among 1,050 previous interferon nonresponders with advanced fibrosis or cirrhosis. We investigated whether reduced hepatic inflammation was associated with clinical benefit in 834 patients with a baseline and follow-up biopsy 1.5 years after randomization to peginterferon or observation.

methodsRelationships between change in hepatic inflammation (Ishak hepatic activity index, (HAI)) and serum alanine aminotransferase level, fibrosis progression and clinical outcomes after randomization, and hepatitis C virus (HCV) RNA decline before and after randomization were evaluated. Histological change was defined as a ≥ 2-point difference in HAI or Ishak fibrosis score between biopsies.

resultsAmong 657 patients who received full-dose peginterferon/ribavirin "lead-in" therapy before randomization, year-1.5 HAI improvement was associated with lead-in HCV RNA suppression in both the randomized treated (P<0.0001) and control (P=0.0001) groups, even in the presence of recurrent viremia. This relationship persisted at year 3.5 in both the treated (P=0.001) and control (P=0.01) groups. Among 834 patients followed for a median of 6 years, fewer clinical outcomes occurred in patients with improved HAI at year 1.5 compared with those without such improvement in both the treated (P=0.03) and control (P=0.05) groups. Among patients with Ishak 3-4 fibrosis at baseline, those with improved HAI at year 1.5 had less fibrosis progression at year 1.5 in both the treated (P=0.0003) and control (P=0.02) groups.

conclusionsReduced hepatic inflammation (measured 1.5 and 3.5 years after randomization) was associated with profound virological suppression during lead-in treatment with full-dose peginterferon/ribavirin and with decreased fibrosis progression and clinical outcomes, independent of randomized treatment.

Indexed as

AdultAgedAntiviral AgentsBiopsyDisease ProgressionDrug Therapy, CombinationFemaleFollow-Up StudiesHepatitis C, ChronicHumansInterferon-alphaKaplan-Meier EstimateLiverLiver CirrhosisLogistic ModelsMaleAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID22688849
PMCPMC3865099
OpenAlexW2033765375

What OpenQuestion holds

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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.