Evidence map›Paper›PMID 23439301›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2013

Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C.

Jean P Molleston, William Mellman, Michael R Narkewicz, William F Balistreri, Regino P Gonzalez-Peralta, Maureen M Jonas, Steven J Lobritto, Parvathi Mohan, Karen F Murray, Dolores Njoku and 7 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2013. 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 22% 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, 21 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Article
  6. Prevalence and Significance of Autoantibodies in Children With Acute Liver Failure.Journal of pediatric gastroenterology and nutrition · 2017
    Article
  7. Diabetes and Hepatitis C: A Two-Way Association.Frontiers in endocrinology · 2015
    Review
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Jean P MollestonSection of Pediatric Gastroenterology, Hepatology, and Nutrition, Indiana University School of Medicine, Indianapolis, IN, USA.
William Mellman
Michael R Narkewicz
William F Balistreri
Regino P Gonzalez-Peralta
Maureen M Jonas
Steven J Lobritto
Parvathi Mohan
Karen F Murray
Dolores Njoku
Philip Rosenthal
Bruce A Barton
Monica V Talor
Irene Cheng
Kathleen B Schwarz
Barbara A Haber
PEDS-C Clinical Research Network
Johns Hopkins University · USChildren's Hospital of Philadelphia · USBoston Children's Museum · USChildren's National · USCincinnati Children's Hospital Medical Center · USClinical Trials and Surveys Corporation · USColumbia University Irving Medical Center · USFlorida College · USIndiana University School of MedicineMaryland Medical Research Institute · USSeattle Children's Hospital · USUniversity of California, San Francisco · USUniversity of Colorado Denver · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
ZIPRASIDONE IN NORMAL HEPATIC FUNCTION SUBJECTS &IN HEPATIC DYSFUCTIN SUBJECTSM01RR000037 · NCRR · UNIVERSITY OF WASHINGTON · PI MCDONALD, RUTH C · 1985 to 2007
$33.8M
UCSF Liver Core CenterP30DK026743 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Holger Willenbring · 1986 to 2026
$30.7M
WHITE MATTER AND COGNITION IN PARKINSON'S DISEASEM01RR000082 · NCRR · UNIVERSITY OF FLORIDA · PI FOOTE, KELLY D · 1985 to 2009
$29.7M
ZOLEDRONIC ACID IN PROSTATE CANCERM01RR000645 · NCRR · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI COLTEN, HARVEY R · 1985 to 2006
$27.0M
ZOSUQUIDAR TRIHYDROCHLORIDE DURING CONVENTIONAL INDUCTION AND POST-REMISSIONM01RR000750 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI RODRIGUEZ, HENRY · 1985 to 2008
$25.5M
ZIDOVUDINE &LAMIVUDINE &NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFM01RR001271 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$22.7M
ZORVIRAX ORAL SUSPENSION FOR SEVERE CHILDHOOD HERPES VIRUS INFECTIONSM01RR000069 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 1985 to 2008
$22.1M
VITAMIN K DEFICIENCY IN CHOLESTATIC LIVER DISEASEM01RR008084 · NCRR · CINCINNATI CHILDRENS HOSP MED CTR · PI HEUBI, JAMES E. · 1994 to 2009
$20.6M
WIRELESS CAPSULE ENDOSCOPY TO EVALUATE THE SMALL INTESTINE M01RR002172 · NCRR · CHILDREN'S HOSPITAL BOSTON · PI MANDELL, JAMES WILLIAM · 1985 to 2008
$16.0M
ZIDOVUDINE VS 2',3'DIDEHYDRO-3'DEOXYTHYMIDINE IN CHILDRENM01RR000240 · NCRR · CHILDREN'S HOSP OF PHILADELPHIA · PI ALTSCHULER, STEVEN M · 1985 to 2006
$15.3M
ZAP-70 EXPRESSION, CD38 EXPRESSION AND PROGNOSIS IN CHRONIC LYMPHOCYTIC LEUKEMIAM01RR020359 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI HINDS, PAMELA S · 2005 to 2010
$13.8M
NCRR NIH HHS 5M01 RR-000240NCRR NIH HHS 5-M01-RR-020359-01NCRR NIH HHS M01 RR000037NCRR NIH HHS M01 RR000069NCRR NIH HHS M01 RR000082NCRR NIH HHS M01 RR000240NCRR NIH HHS M01-RR-00037NCRR NIH HHS M01 RR000645NCRR NIH HHS M01-RR-00069NCRR NIH HHS M01 RR000750NCRR NIH HHS M01-RR-00082NCRR NIH HHS M01 RR001271NCRR NIH HHS M01 RR002172NCRR NIH HHS M01-RR-00645NCRR NIH HHS M01-RR-00750NCRR NIH HHS M01 RR008084NCRR NIH HHS M01-RR-01271NCRR NIH HHS M01 RR020359NCRR NIH HHS M01-RR-02172NCRR NIH HHS M01-RR-08084NCRR NIH HHS UL1 RR025780NIDDK NIH HHS 1U01DK067767-01NIDDK NIH HHS P30 DK026743NIDDK NIH HHS U01 DK067767NIDDK NIH HHS U01-DK-067767-02NIDDK NIH HHS U01 DK084536
6 · The paper itself

Abstract

objectivesAutoantibodies were studied in a well-characterized cohort of children with chronic hepatitis C during treatment with pegylated interferon and ribavirin to assess the relation with treatment and development of autoimmune disease.

methods: A total of 114 children (5-17 years), screened for the presence of high-titer autoantibodies, were randomized to pegylated interferon with or without ribavirin. Anti-nuclear, anti-liver-kidney-microsomal, anti-thyroglobulin, anti-thyroid peroxidase, insulin, anti-glutamic acid decarboxylase (GAD) antibodies were measured after trial completion using frozen sera.

resultsAt baseline, 19% had autoantibodies: anti-nuclear antibodies (8%), anti-liver-kidney-microsomal antibodies (4%), and glutamic acid decarboxylase antibodies (4%). At 24 and 72 weeks (24 weeks after treatment completion), 23% and 26% had autoantibodies (P=0.50, 0.48 compared with baseline). One child developed diabetes and 2 hypothyroidism during treatment; none developed autoimmune hepatitis. At 24 weeks, the incidence of flu-like symptoms, gastrointestinal symptoms, and headaches was 42%, 8% and 19% in those with autoantibodies versus 52%, 17%, and 26% in those without (P=0.18, 0.36, and 0.20, respectively). In children with negative hepatitis C virus polymerase chain reaction at 24 weeks, there was no difference in the rate of early virologic response/sustained virologic response, respectively, in those with autoantibodies 76%/69% vs 58%/65% in those without (P=0.48).

conclusionsDespite screening, we found autoantibodies commonly at baseline, during treatment for chronic hepatitis C and after. The presence of antibodies did not correlate with viral response, adverse effects, or autoimmune hepatitis. Neither screening nor archived samples assayed for thyroid and diabetes-related antibodies identified the 3 subjects who developed overt autoimmune disease, diabetes (1), and hypothyroidism (2).

Indexed as

AdolescentAntiviral AgentsAutoantibodiesAutoimmune DiseasesChildChild, PreschoolCohort StudiesDrug Resistance, Multiple, ViralDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansIncidenceInterferon-alphaLongitudinal StudiesAntiviral AgentsAutoantibodiesInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID23439301
PMCPMC3583208
OpenAlexW2023702382

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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.