Evidence map›Paper›PMID 24815494›Full record

Trial reportAlimentary pharmacology & therapeutics2014

Long-term therapy of chronic delta hepatitis with peginterferon alfa.

T Heller, Y Rotman, C Koh, S Clark, V Haynes-Williams, R Chang, R McBurney, P Schmid, J Albrecht, D E Kleiner and 3 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 3% 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

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 117 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Impact of Handling Perception and Language Barriers on Virologic Response to Daily Subcutaneous Bulevirtide in Hepatitis D.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Article
  6. Review
  7. Article
  8. Bulevirtide in Chronic Hepatitis D Patients Awaiting Liver Transplantation Results From a French Multicentric Retrospective Study.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Article
  9. Review
  10. Article
  11. Article
  12. Current and future therapeutic options for chronic hepatitis D virus infection.Frontiers in cellular and infection microbiology · 2024
    Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Present and future management of viral hepatitis.World journal of gastroenterology · 2021
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

T HellerLiver Diseases Branch, National Institute of Diabetes & Digestive & Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.
Y Rotman
C Koh
S Clark
V Haynes-Williams
R Chang
R McBurney
P Schmid
J Albrecht
D E Kleiner
M G Ghany
T J Liang
J H Hoofnagle
National Institute of Diabetes and Digestive and Kidney Diseases · USNational Institutes of Health · USNational Institutes of Health Clinical Center · USNational Research Institute · US

Funding

Histology Core LaboratoryZICBC010687 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CHINQUEE, JOSEPH · 2009 to 2025
$35.1M
Molecular Mechanisms Of Hepatitis B Viral Pathogenesis And PersistenceZIADK054500 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI LIANG, T. JAKE · 2009 to 2025
$20.3M
Investigation of management and disease manifestations of viral hepatitisZIADK054514 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI HELLER, THEO · 2009 to 2025
$12.9M
Investigation of management and disease manifestations of viral hepatitisZ01DK054514 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI HELLER, THEO · 2007 to 2008
$838k
Intramural NIH HHS Z01 DK054514
6 · The paper itself

Abstract

backgroundChronic delta hepatitis virus (HDV) infection rapidly progresses to cirrhosis. Treatment with peginterferon for up to 2 years is often without durable response.

aimTo examine the efficacy and safety of long-term peginterferon in achieving a durable response.

methodsTreatment was initiated with 180 μg/week of peginterferon alfa-2a with titration to a maximal tolerable dose, for up to 5 years. Liver biopsies and hepatic venous pressure gradients (HVPG) were evaluated at baseline, 1, 3 and 5 years. The primary endpoint was histological improvement or loss of serum HDV and HBsAg at 3 years.

resultsThirteen patients were treated for a median of 140 weeks (6-260) with an average peginterferon dose of 180 μg/week (90-270). At baseline, most had advanced disease (median Ishak fibrosis = 3) with portal hypertension (HVPG = 10.2 ± 6 mmHg). Five of 13 patients (39%) achieved the primary endpoint, with three seroconverting for HBsAg after 24, 37 and 202 weeks of treatment. Histological inflammation improved after 1 year, (median HAI: 10 vs. 7, P = 0.01) with persistence in 4/5 patients at 3 years (median HAI: 7.5). Greatest improvements occurred in the first year. Baseline bilirubin and HBsAg levels were significantly lower in virological responders than nonresponders. After 12 weeks, virological responders had a significant decline in HBsAg (1.5 log10 IU/mL, P = 0.05).

conclusionDespite increased doses and duration of therapy, treatment of chronic HDV with peginterferon remains unsatisfactory. Quantitative measures of HBsAg may be an important biomarker of early response to peginterferon therapy in chronic delta hepatitis virus infection.

Indexed as

AdolescentAdultAgedAngiogenesis InhibitorsAntiviral AgentsDisease ProgressionDose-Response Relationship, DrugFemaleHepatitis B Surface AntigensHepatitis D, ChronicHumansInterferon-alphaLiver CirrhosisMaleMiddle AgedPolyethylene GlycolsAngiogenesis InhibitorsAntiviral AgentsHepatitis B Surface AntigensInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID24815494
PMCPMC5510621
OpenAlexW2166256081

What OpenQuestion holds

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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.