Evidence map›Paper›PMID 29998882›Full record

Trial reportChinese medical journal2018

Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study).

Dae Won Jun, Sang Bong Ahn, Tae Yeob Kim, Joo Hyun Sohn, Sang Gyune Kim, Se Whan Lee, Byung Ho Kim, Dong Joon Kim, Ja Kyung Kim, Hyoung Su Kim and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Chinese medical journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01220596 (A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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.

NCT01220596 phase3unknown statusnot on this map

A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a(Pegasys(TM)) Following Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.

TypeinterventionalSponsorHanyang UniversityRan2010 to 2013Enrolled228ConditionsHepatitis B, ChronicArmsEntecavir and Pegylated interferon α-2a Sequential Treatment Group, Pegylated interferon α-2a Monotreatment Group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Entecavir for children and adults with chronic hepatitis B.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Efficacy and Safety of PeginterferonContrast media & molecular imaging · 2022
    Article
  3. 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

22 authors at 20 institutions in 1 country.

Dae Won JunDepartment of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University, Seoul 04763, Korea.
Sang Bong AhnDepartment of Internal Medicine, Nowon Eulji Hospital, Eulji University, Seoul 01830, Korea.
Tae Yeob KimDepartment of Internal Medicine, Hanyang University Guri Hospital, Hanyang University, Guri 11923, Korea.
Joo Hyun SohnDepartment of Internal Medicine, Hanyang University Guri Hospital, Hanyang University, Guri 11923, Korea.
Sang Gyune KimDepartment of Internal Medicine, SoonChunHyang University Bucheon Hospital, SoonChunHyang University, Bucheon 14584, Korea.
Se Whan LeeDepartment of Internal Medicine, SoonChunHyang University Cheonan Hospital, SoonChunHyang University, Cheonan 31151, Korea.
Byung Ho KimDepartment of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul 02453, Korea.
Dong Joon KimDepartment of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon 24252, Korea.
Ja Kyung KimDepartment of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University, Seoul 05355, Korea.
Hyoung Su KimDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University, Seoul 06273, Korea.
Seong Gyu HwangDepartment of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam 13496, Korea.
Won Choong ChoiDepartment of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul 01757, Korea.
Won Young TakDepartment of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University, Daegu 41944, Korea.
Heon Ju LeeDepartment of Internal Medicine, Yeungnam University Medical Center, Yeungnam University, Daegu 42415, Korea.
Ki Tae YoonDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University, Yangsan 50612, Korea.
Byung Cheol YunDepartment of Internal Medicine, Kosin University Gospel Hospital, Kosin University, Pusan 49267, Korea.
Sung Wook LeeDepartment of Internal Medicine, Dong A University Medical Center, Dong A University, Pusan 49201, Korea.
Soon Koo BaikDepartment of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University, Wonju 26426, Korea.
Seung Ha ParkDepartment of Internal Medicine, Haeundae Paik Hospital, Inje University, Pusan 48108, Korea.
Ji Won ParkDepartment of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University, Anyang 14068, Korea.
Sol Ji ParkDepartment of Clinical Pharmacy, Graduate School of Clinical Pharmacy, Sungkyunkwan University, Suwon 16419, Korea.
Ji Sung LeeClinical Research Center, Asan Medical Center, Seoul 05505, Korea.
Hanyang University Guri Hospital · KRInje University Haeundae Paik Hospital · KRAsan Medical Center · KRBucheon University · KRCHA University Bundang Medical Center · KRDong-A University · KREulji University · KRGangnam Severance Hospital · KRHallym University · KRHallym University Sacred Heart Hospital · KRHanyang University Seoul Hospital · KRInje University Sanggye Paik Hospital · KRKangdong Sacred Heart Hospital · KRKosin University Gospel Hospital · KRKyung Hee University · KRKyungpook National University Hospital · KRPusan National University Yangsan Hospital · KRSoonchunhyang University · KRYeungnam University Medical Center · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUntil now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment.

methodsBetween June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis.

resultsHBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA <2000 U/L (28.8% vs. 28.8%, t = 0.10, P = 1.000) was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate (HBeAg seroconversion and serum HBV-DNA <2000 U/L) was not different in the two groups (12.1% vs. 16.7%, t = 1.83, P = 0.457). Baseline HBV-DNA level (7 log

conclusionsThe current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.

trial registrationClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/show/NCT01220596?term=NCT01220596&rank=1.

Indexed as

Antiviral AgentsDNA, ViralGuanineHepatitis BHepatitis B, ChronicHepatitis B e AntigensHumansInterferon-alphaPolyethylene GlycolsRecombinant ProteinsRepublic of KoreaTreatment OutcomeAntiviral AgentsDNA, ViralentecavirGuanineHepatitis B e AntigensInterferon-alphaPolyethylene GlycolsRecombinant ProteinsEntecavirHepatitis BPeginterferon Alfa-2a

Identifiers

PMID29998882
PMCPMC6048918
OpenAlexW2809818848

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

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.