Evidence map›Paper›PMID 37804353›Full record

ArticleDigestive diseases and sciences2023

Symptoms of Liver Disease During Tenofovir Therapy With or Without Peginterferon: Results from the Hepatitis B Research Network Immune Active Trial.

Donna M Evon, Hsing-Hua S Lin, Mandana Khalili, Abdus S Wahed, Colina Yim, Robert J Fontana, Jay H Hoofnagle, Hepatitis B Research Network (HBRN)

Open access · greenAbstract read
In one paragraph

Article in Digestive diseases and sciences, 2023. 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, top 74% 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

1 citing paper in PubMed, 0 citations in OpenAlex.

  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 at 6 institutions in 2 countries.

Donna M EvonDivision of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. Donna_evon@med.unc.edu.ORCID 0000-0002-1414-1846
Hsing-Hua S LinDepartments of Epidemiology and Biostatistics, University of Pittsburgh, Pittsburgh, USA.
Mandana KhaliliDepartment of Medicine, University of California at San Francisco, San Francisco, USA.
Abdus S WahedDepartment of Biostatistics, University of Pittsburgh, Pittsburgh, USA.
Colina YimToronto Centre for Liver Disease, University of Toronto, Toronto, Canada.
Robert J FontanaDepartment of Internal Medicine, University of Michigan, Ann Arbor, USA.
Jay H HoofnagleLiver Disease Research Branch, National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institutes of Health (NIH), Bethesda, USA.
Hepatitis B Research Network (HBRN)
University of Pittsburgh · USNational Institutes of Health · USUniversity of California, San Francisco · USUniversity of Michigan · USUniversity of North Carolina at Chapel Hill · USUniversity of Toronto · CA

Funding

Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
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
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
TRANSGENIC AND CHIMERIC MOUSE COREP30DK050306 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI REBECCA G WELLS · 1997 to 2026
$32.5M
Hepatitis B Research Network - Data Coordination CenterU01DK082864 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BELLE, STEVEN H. · 2008 to 2019
$25.3M
ZDV VS ZDV + DDL VS ZDV + DDL + NVP IN ASYMPTOMATIC HIV PATIENTSM01RR000040 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 1985 to 2006
$21.1M
Center for Clinical and Translational ResearchUL1TR000058 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2015
$12.5M
Hepatitis B Research Network (HBRN): Natural History and Treatment StudiesU01DK082944 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COOPER, STEWART, KHALILI, MANDANA · 2008 to 2019
$10.0M
Observation Study of Persons with Chronic Hepatitis B Virus infection in North AmericaU01DK082874 · NIDDK · UNIVERSITY HEALTH NETWORK · PI JANSSEN, HARRY · 2008 to 2019
$6.9M
Harvard Hepatitis B ConsortiumU01DK082919 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI CHUNG, RAYMOND T, LAU, DARYL T · 2008 to 2019
$4.7M
Midwest Hepatitis B ConsortiumU01DK082871 · NIDDK · SAINT LOUIS UNIVERSITY · PI DI BISCEGLIE, ADRIAN MICHAEL · 2008 to 2019
$4.7M
Hepatitis B Clinical Research Network Clinical Center: Michigan - Hawaii ConsortiumU01DK082863 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LOK, ANNA S.F. · 2008 to 2020
$3.7M
NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000058NCATS NIH HHS UL1 TR001111NCRR NIH HHS M01 RR000040NCRR NIH HHS UL1 RR024986NIAAA NIH HHS K24 AA022523NIDDK NIH HHS P30 DK050306NIDDK NIH HHS U01 DK082843NIDDK NIH HHS U01 DK082863NIDDK NIH HHS U01 DK082864NIDDK NIH HHS U01 DK082866NIDDK NIH HHS U01 DK082867NIDDK NIH HHS U01 DK082871NIDDK NIH HHS U01 DK082872NIDDK NIH HHS U01 DK082874NIDDK NIH HHS U01 DK082919NIDDK NIH HHS U01 DK082923NIDDK NIH HHS U01 DK082927NIDDK NIH HHS U01 DK082943NIDDK NIH HHS U01 DK082944
6 · The paper itself

Abstract

aimsEvaluate patient-reported liver symptoms during treatment for chronic hepatitis B viral (HBV) infection and associations between changes in symptoms and levels of alanine aminotransferase (ALT) and viral markers.

methodsData from 200 participants in the Hepatitis B Research Network Immune Active Trial who completed symptom assessments were analyzed. Patients were treated with tenofovir, with or without peginterferon (TDF + PegIFN vs. TDF alone) for 192 weeks. Participants completed a Symptom Checklist at baseline and every 4-12 weeks. A total symptom score was created, ranging from 0 (none) to 40 (severe). The SF-36 was completed every 48 weeks. Associations of symptom scores with ALT and viral markers were evaluated at baseline and end of treatment.

resultsParticipants were 65% male, 83% Asian, with a mean age of 42. Baseline symptoms were mild (median = 2, range 0-25) and associated with baseline ALT, HBV DNA levels and HBeAg + status. Patients on TDF alone experienced a more rapid and greater improvement in symptoms, but by week 192, symptom improvement was similar in both groups (54% vs 36%). Symptom improvements correlated with ALT and HBV DNA, most markedly among those with symptoms at baseline. Most patients (4 out of 6) who achieved HBsAg loss experienced symptom improvements. Overall, SF-36 scores did not change with treatment.

conclusionsReduction in ALT and HBV DNA levels with therapy are associated with significant improvement in liver symptoms such as fatigue and pain over the liver, especially among those with higher ALT, HBV DNA, symptoms and HBeAg + status prior to treatment.

Indexed as

Antiviral AgentsHepatitis B, ChronicAdultBiomarkersDNA, ViralFemaleHepatitis B e AntigensHepatitis B virusHumansMaleTenofovirTreatment OutcomeAntiviral AgentsBiomarkersDNA, ViralHepatitis B e AntigensTenofovirInstrumentMeasurePatient-reported outcomes, liverQuestionnaireRandomized controlled trialSurvey

Identifiers

PMID37804353
PMCPMC11149619
OpenAlexW4387424989

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.