Evidence map›Paper›PMID 38190830›Full record

Trial reportClinical and molecular hepatology2024

Efficacy, safety, and pharmacokinetics of capsid assembly modulator linvencorvir plus standard of care in chronic hepatitis B patients.

Jinlin Hou, Edward Gane, Rozalina Balabanska, Wenhong Zhang, Jiming Zhang, Tien Huey Lim, Qing Xie, Chau-Ting Yeh, Sheng-Shun Yang, Xieer Liang and 16 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.5field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. [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
  4. Functional Cure for Hepatitis B Virus: Challenges and Achievements.International journal of molecular sciences · 2025
    Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 17 institutions in 9 countries.

Jinlin HouNanfang Hospital, Southern Medical University, Guangzhou, China.
Edward GaneNew Zealand Liver Transplant Unit, The University of Auckland, Auckland, New Zealand.
Rozalina BalabanskaAcibadem City Clinic Tokuda Hospital EAD, Sofia, Bulgaria.
Wenhong ZhangHuashan Hospital, Fudan University, Shanghai, China.
Jiming ZhangHuashan Hospital, Fudan University, Shanghai, China.
Tien Huey LimMiddlemore Hospital, Auckland, New Zealand.
Qing XieRuijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Chau-Ting YehChang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan.
Sheng-Shun YangTaichung Veterans General Hospital, Taichung, Taiwan.
Xieer LiangNanfang Hospital, Southern Medical University, Guangzhou, China.
Piyawat KomolmitKing Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Apinya LeerapunMaharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand.
Zenghui XueRoche (China) Holding, Shanghai, China.
Ethan ChenRoche (China) Holding, Shanghai, China.
Yuchen ZhangChina Innovation Center of Roche, Shanghai, China.
Qiaoqiao XieChina Innovation Center of Roche, Shanghai, China.
Ting-Tsung ChangNational Cheng Kung University Hospital, Tainan, Taiwan.
Tsung-Hui HuChang Gung Memorial Hospital, Kaohsiung Branch, Kaohsiung, Taiwan.
Seng Gee LimNational University Health System, Singapore.
Wan-Long ChuangKaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Barbara LeggettRoyal Brisbane & Women's Hospital, School of Medicine, University of Queensland, Queensland, Australia.
Qingyan BoRoche (China) Holding, Shanghai, China.
Xue ZhouChina Innovation Center of Roche, Shanghai, China.
Miriam TriyatniRoche Innovation Centre, Basel, Switzerland.
Wen ZhangChina Innovation Center of Roche, Shanghai, China.
Man-Fung YuenDepartment of Medicine, School of Clinical Medicine, State Key Laboratory of Liver Research, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
Roche (China) · CNFudan University · CNNanfang Hospital · CNRuijin Hospital · CNChang Gung Memorial Hospital · TWKaohsiung Chang Gung Memorial Hospital · TWKaohsiung Medical University · TWKing Chulalongkorn Memorial Hospital · THMaharaj Nakorn Chiang Mai Hospital · THNational Cheng Kung University Hospital · TWNational University Health System · SGQueen Mary Hospital · CNRoche (Switzerland) · CHTaichung Veterans General Hospital · TWThe University of Queensland · AUTokuda Hospital · BGUniversity of Auckland · NZ

Funding

AbbVieAiCurisAligos TherarpeuticsAntios TherapeuticsArbutus BiopharmaArrowhead PharmaceuticalsAssembly BiosciencesBluejay TherapeuticsBristol Myers SquibbClear B TherapeuticsDicerna PharmaceuticalsFinch TherapeuticsFujirebio IncorporationGilead SciencesGlaxoSmithKlineHoffmann-La RocheImmunocoreJanssenJohnson & JohnsonMerck Sharp and DohmeVir Biotechnology
6 · The paper itself

Abstract

BACKGROUND/

aimsFour-week treatment of linvencorvir (RO7049389) was generally safe and well tolerated, and showed anti-viral activity in chronic hepatitis B (CHB) patients. This study evaluated the efficacy, safety, and pharmacokinetics of 48-week treatment with linvencorvir plus standard of care (SoC) in CHB patients.

methodsThis was a multicentre, non-randomized, non-controlled, open-label phase 2 study enrolling three cohorts: nucleos(t)ide analogue (NUC)-suppressed patients received linvencorvir plus NUC (Cohort A, n=32); treatment-naïve patients received linvencorvir plus NUC without (Cohort B, n=10) or with (Cohort C, n=30) pegylated interferon-α (Peg-IFN-α). Treatment duration was 48 weeks, followed by NUC alone for 24 weeks.

results68 patients completed the study. No patient achieved functional cure (sustained HBsAg loss and unquantifiable HBV DNA). By Week 48, 89% of treatment-naïve patients (10/10 Cohort B; 24/28 Cohort C) reached unquantifiable HBV DNA. Unquantifiable HBV RNA was achieved in 92% of patients with quantifiable baseline HBV RNA (14/15 Cohort A, 8/8 Cohort B, 22/25 Cohort C) at Week 48 along with partially sustained HBV RNA responses in treatment-naïve patients during follow-up period. Pronounced reductions in HBeAg and HBcrAg were observed in treatment-naïve patients, while HBsAg decline was only observed in Cohort C. Most adverse events were grade 1-2, and no linvencorvir-related serious adverse events were reported.

conclusion48-week linvencorvir plus SoC was generally safe and well tolerated, and resulted in potent HBV DNA and RNA suppression. However, 48-week linvencorvir plus NUC with or without Peg-IFN did not result in the achievement of functional cure in any patient.

Indexed as

Antiviral AgentsHepatitis B, ChronicImidazolesPyrazinesCapsidDNA, ViralHepatitis B e AntigensHepatitis B Surface AntigensHepatitis B virusHumansPolyethylene GlycolsRNAStandard of CareTreatment OutcomeAntiviral AgentsDNA, ViralHepatitis B e AntigensHepatitis B Surface AntigensImidazoleslinvencorvirPolyethylene GlycolsPyrazinesRNACapsid assembly modulatorChronic hepatitis BLinvencorvirPhase 2RO7049389

Identifiers

PMID38190830
PMCPMC11016473
OpenAlexW4390658624

What OpenQuestion holds

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LicenceCC BY-NC
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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.