Evidence map›Paper›PMID 38528825›Full record

Trial reportClinical and molecular hepatology2024

Phase 1 trial of the safety, pharmacokinetics, and antiviral activity of EDP-514 in untreated viremic chronic hepatitis B patients.

Man-Fung Yuen, Wan-Long Chuang, Cheng-Yuan Peng, Wen-Juei Jeng, Wei-Wen Su, Ting-Tsung Chang, Chi-Yi Chen, Yao-Chun Hsu, Guy De La Rosa, Alaa Ahmad and 2 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and molecular hepatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. [Research progress on new drugs for the treatment of chronic hepatitis B virus infection].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 4 countries.

Man-Fung YuenDepartment of Medicine, School of Clinical Medicine, Queen Mary Hospital, and State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong.
Wan-Long ChuangHepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Cheng-Yuan PengCenter for Digestive Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan.
Wen-Juei JengDepartment of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou Branch, Taiwan.
Wei-Wen SuDepartment of Gastroenterology and Hepatology, Changhua Christian Hospital, Changhua, Taiwan.
Ting-Tsung ChangDepartment of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Chi-Yi ChenDepartment of Internal Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi, Taiwan.
Yao-Chun HsuCenter for Liver Diseases and School of Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan.
Guy De La RosaFormerly Enanta Pharmaceuticals, Inc., Watertown, MA, USA.
Alaa AhmadEnanta Pharmaceuticals, Inc., Watertown, MA, USA.
Ed LuoEnanta Pharmaceuticals, Inc., Watertown, MA, USA.
Annie L ConeryEnanta Pharmaceuticals, Inc., Watertown, MA, USA.
Enanta Pharmaceuticals (United States) · USChang Gung University · TWChanghua Christian Hospital · TWChia-Yi Christian Hospital · TWChina Medical University · TWE-Da Hospital · TWKaohsiung Medical University · TWNational Cheng Kung University Hospital · TWQueen Mary Hospital · CN

Funding

AbbVieArbutus BiopharmaArrowhead PharmaceuticalsAssembly BiosciencesBristol Myer SquibbChang Gung Medical FoundationDicerna PharmaceuticalsE-Da HospitalEnanta Pharmaceuticals, Inc. EDP 514-002Fujirebio IncorporationGilead SciencesGlaxoSmithKlineHoffmann-La RocheImmunocoreMerck Sharp and DohmeMinistry of Health and WelfareMinistry of Science and Technology, TaiwanNational Science Council TaiwanTomorrow Medical Foundation
6 · The paper itself

Abstract

BACKGROUND/

aimsOral EDP-514 is a potent core protein inhibitor of hepatitis B virus (HBV) replication, which produced a >4-log viral load reduction in HBV-infected chimeric mice with human liver cells. This study evaluated the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in treatment-naive viremic patients with HBeAgpositive or -negative chronic HBV infection.

methodsPatients with HBsAg detectable at screening and at least 6 months previously were eligible. HBeAg-positive and -negative patients had a serum/plasma HBV DNA level ≥20,000 and ≥2,000 IU/mL, respectively. Twenty-five patients were randomized to EDP-514 200 (n=6), 400 (n=6) or 800 mg (n=7) or placebo (n=6) once daily for 28 days.

resultsA dose-related increase in EDP-514 exposure (AUClast and Cmax) was observed across doses. At Day 28, mean reductions in HBV DNA were -2.9, -3.3, -3.5 and -0.2 log10 IU/mL with EDP-514 200 mg, 400 mg, 800 mg, and placebo groups, respectively. The corresponding mean change from baseline for HBV RNA levels was -2.9, -2.4, -2.0, and -0.02 log10 U/mL. No virologic failures were observed. No clinically meaningful changes from baseline were observed for HBsAg, HBeAg or HBcrAg. Nine patients reported treatment emergent adverse events of mild or moderate severity with no discontinuations, serious AEs or deaths.

conclusionIn treatment-naïve viremic patients, oral EDP-514 was generally safe and well-tolerated, displayed PK profile supportive of once-daily dosing, and markedly reduced HBV DNA and HBV RNA.

Indexed as

Antiviral AgentsDNA, ViralHepatitis B, ChronicHepatitis B e AntigensHepatitis B virusAdultDose-Response Relationship, DrugDouble-Blind MethodFemaleGuanineHepatitis B Surface AntigensHumansMaleMiddle AgedOrganophosphonatesViral Load((1-((2-amino-9H-purin-9-yl)methyl)cyclopropyl)oxy)methylphosphonic acid dipivoxylAntiviral AgentsDNA, ViralGuanineHepatitis B e AntigensHepatitis B Surface AntigensOrganophosphonatesChronic hepatitis BCore protein inhibitorHepatitis B virusPharmacokineticsSafety

Identifiers

PMID38528825
PMCPMC11261219
OpenAlexW4393195828

What OpenQuestion holds

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LicenceCC BY-NC
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 OpenQuestion graph.