Evidence map›Paper›PMID 30689258›Full record

Trial reportAlimentary pharmacology & therapeutics2019

Low hepatitis B surface antigen and HBV DNA levels predict response to the addition of pegylated interferon to entecavir in hepatitis B e antigen positive chronic hepatitis B.

Kin Seng Liem, Margo J H van Campenhout, Qing Xie, Willem Pieter Brouwer, Heng Chi, Xun Qi, Liang Chen, Fehmi Tabak, Bettina E Hansen, Harry L A Janssen

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.4field-weighted citation impact, top 8% 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.

NCT00877760 phase4completednot on this map

Augmenting Response to Entecavir Using a Temporary Peginterferon Alpha-2a add-on Strategy for the Treatment of HBeAg-positive Chronic Hepatitis B

TypeinterventionalSponsorFoundation for Liver ResearchRan2009 to 2013Enrolled184ConditionsChronic Hepatitis BArmspegylated interferon a-2a, Entecavir
NCT01532843 phase4completednot on this map

Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B (PEGON-study)

TypeinterventionalSponsorFoundation for Liver ResearchRan2012 to 2015Enrolled82ConditionsChronic Hepatitis BArmsPegIFN alfa-2b
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 31 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Advances in treatment and prevention of hepatitis B.World journal of gastrointestinal pharmacology and therapeutics · 2021
    Review
  11. Review
  12. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 4 countries.

Kin Seng LiemToronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.ORCID 0000-0002-3585-2778
Margo J H van CampenhoutDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.ORCID 0000-0003-0460-4920
Qing XieDepartment of Infectious Diseases, Ruijin Hospital, Jiaotong University, Shanghai, China.
Willem Pieter BrouwerDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.ORCID 0000-0001-8713-1481
Heng ChiDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.
Xun QiDepartment of Hepatitis Disease, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Liang ChenDepartment of Hepatitis Disease, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Fehmi TabakÇerrahpasa Medical Faculty, Istanbul, Turkey.
Bettina E HansenToronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
Harry L A JanssenToronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
Erasmus MC · NLUniversity Health Network · CAShanghai Public Health Clinical Center · CNIstanbul University-Cerrahpaşa · TRRuijin Hospital · CN

Funding

Foundation for Liver Research, Rotterdam, The Netherlands
6 · The paper itself

Abstract

backgroundVarious treatment combinations of peginterferon (PEG-IFN) and nucleos(t)ide analogues have been evaluated for chronic hepatitis B (CHB), but the optimal regimen remains unclear.

aimsTo study whether PEG-IFN add-on increases response compared to entecavir (ETV) monotherapy, and whether the duration of ETV pretreatment influences response.

methodsResponse was evaluated in HBeAg positive patients previously treated in two randomized controlled trials. Patients received ETV pretreatment for at least 24 weeks and were then allocated to 24-48 weeks of ETV+PEG-IFN add-on, or continued ETV monotherapy. Response was defined as HBeAg loss combined with HBV DNA <200 IU/mL 48 weeks after discontinuing PEG-IFN.

resultsOf 234 patients, 118 were assigned PEG-IFN add-on and 116 continued ETV monotherapy. Response was observed in 38/118 (33%) patients treated with add-on therapy and in 23/116 (20%) with monotherapy (P = 0.03). The highest response to add-on therapy compared to monotherapy was observed in PEG-IFN naive patients with HBsAg levels below 4000 IU/mL and HBV DNA levels below 50 IU/mL at randomization (70% vs 34%; P = 0.01). Above the cut-off levels, response was low and not significantly different between treatment groups. Duration of ETV pretreatment was associated with HBsAg and HBV DNA levels (both P < 0.005), but not with response (P = 0.82).

conclusionsPEG-IFN add-on to ETV therapy was associated with higher response compared to ETV monotherapy in patients with HBeAg positive CHB. Response doubled in PEG-IFN naive patients with HBsAg below 4000 IU/mL and HBV DNA below 50 IU/mL, and therefore identifies them as the best candidates for PEG-IFN add-on (Identifiers: NCT00877760, NCT01532843).

Indexed as

AdultAntiviral AgentsDNA, ViralDrug Therapy, CombinationFemaleGuanineHepatitis B, ChronicHepatitis B e AntigensHepatitis B Surface AntigensHumansInterferon-alphaMalePolyethylene GlycolsYoung AdultAntiviral AgentsDNA, ViralentecavirGuanineHepatitis B e AntigensHepatitis B Surface AntigensInterferon-alphaPolyethylene Glycols

Identifiers

PMID30689258
PMCPMC6590282
OpenAlexW2913926637

What OpenQuestion holds

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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.