Trial reportJournal of viral hepatitis2021
Farnesoid X receptor agonist for the treatment of chronic hepatitis B: A safety study.
Trial report in Journal of viral hepatitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06691412 (Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Entecavir for children and adults with chronic hepatitis B.The Cochrane database of systematic reviews · 2025Pooled it
- Farnesoid X receptor agonist for the treatment of chronic hepatitis B: A safety study.Journal of viral hepatitis · 2021Trial
- The Bile Acid Signaling Axis: Deciphering the Roles of FXR and TGR5 in Hepatic Steatosis, Fibrosis, and Cancer.Pharmacology research & perspectives · 2026Review
- Short-chain Fatty Acids and Bile Acids Signaling in Chronic Hepatitis B.Journal of clinical and translational hepatology · 2026Review
- Review
- Activation of Brown Adipocytes by Farnesoid X Receptor Agonist, Obeticholic Acid-A Potential Novel Therapeutic Avenue in the Management of Obesity.Journal of clinical medicine · 2026Review
- Navigating the Viral Hepatitis Drug Landscape: New Discoveries and Enduring Challenges. A Narrative Review.Infectious diseases and therapy · 2026Review
- Research Progress on the Mechanism and Targeted Intervention of G Protein-Coupled Bile Acid Receptor 1 (GPBAR1)-Mediated "Inflammation-Apoptosis-Metabolism-Microcirculation" Regulatory Network in Hepatitis B-Associated Liver Failure.Drug design, development and therapy · 2026Review
- New mechanistic understanding of FXR agonist Vonafexor: inducing sublethal damage of HBV-positive liver cancer cells via promoting anti-tumor immunity.British journal of cancer · 2025Article
- Emerging therapies for HBsAg seroclearance: spotlight on novel combination strategies.Hepatology international · 2025Review
- Prospect of emerging treatments for hepatitis B virus functional cure.Clinical and molecular hepatology · 2025Review
- Hepatitis B core-related antigen as a promising serological marker for monitoring hepatitis B virus cure.World journal of hepatology · 2025Review
- Current status and challenges of therapeutic targets, novel drugs and delivery systems for hepatitis B: how far to our goal?Frontiers in cellular and infection microbiology · 2025Review
- The Role of Epigallocatechin Gallate (EGCG) in Treatment and Management of Sexually Transmitted Viral Infections.Infectious disorders drug targets · 2025Review
- Investigational RNA Interference Agents for Hepatitis B.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Asiatic acid inhibits HBV cccDNA transcription by promoting HBx degradation.Virology journal · 2024Article
- Farnesoid X receptor: From Structure to Function and Its Pharmacology in Liver Fibrosis.Aging and disease · 2024Review
- Classifying hepatitis B therapies with insights from covalently closed circular DNA dynamics.Virologica Sinica · 2024Review
- Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The nuclear farnesoid X receptor (FXR) regulates bile acid homeostasis and is a drug target for metabolic liver diseases. FXR also plays an important role in hepatitis B virus (HBV) DNA transcription. In vitro and in mice, FXR agonist treatment leads to inhibition of viral replication and a decline in viral proteins, pregenomic RNA (pgRNA) and HBV DNA levels. We aimed to translate this to a clinical use by primarily evaluating the safety and secondary the anti-viral effect of Vonafexor, a FXR agonist, in chronic hepatitis B (CHB) patients. In total, 73 CHB patients were enrolled in a two-part Phase Ib double-blind, placebo-controlled trial. Patients were randomized to receive oral Vonafexor (100, 200 and 400 mg once daily, or 200 mg twice daily), placebo, or entecavir (Part A, n = 48) or to receive Vonafexor (300 mg once daily or 150 mg twice daily), or placebo, combined with pegylated-interferon-α2a (Part B, n = 25) for 29 days. Patients were followed up for 35 days. Enrolled CHB patients were mostly HBeAg-negative. Vonafexor was overall well tolerated and safe. The most frequent adverse events were moderate gastrointestinal events. Pruritus was more frequent with twice-daily compared with once-daily regimens (56%-67% vs. 16%, respectively, p < 0.05). Vonafexor monotherapy of 400 mg once daily decreased HBsAg concentrations (-0.1 log
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