Advances in discovery of novel investigational agents for functional cure of chronic hepatitis B: A comprehensive review of phases II and III therapeutic agents

doi:10.4254/wjh.v16.i3.331

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World Journal of Hepatology

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1948-5182

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Hepatol. Mar 27, 2024; 16(3): 331-343
Published online Mar 27, 2024. doi: 10.4254/wjh.v16.i3.331

Advances in discovery of novel investigational agents for functional cure of chronic hepatitis B: A comprehensive review of phases II and III therapeutic agents

Robert Lam, Joseph K Lim

Robert Lam, Joseph K Lim, Section of Digestive Diseases, Yale University School of Medicine, New Haven, CT 06520, United States

Author contributions: Lam R collected the data; Lam R and Lim JK wrote and revised the manuscript.

Conflict-of-interest statement: Robert Lam reports no conflict of interest; Joseph K Lim has received research funding (to Yale University) from Gilead, Intercept, Inventiva, Novo Nordisk, Pfizer, and Viking.

Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Joseph K Lim, MD, Professor, Section of Digestive Diseases, Yale University School of Medicine, Yale Liver Center, 333 Cedar Street, LMP 1080, New Haven, CT 06520, United States. joseph.lim@yale.edu

Received: November 27, 2023
Peer-review started: November 27, 2023
First decision: January 5, 2024
Revised: January 23, 2024
Accepted: February 29, 2024
Article in press: February 29, 2024
Published online: March 27, 2024
Processing time: 120 Days and 14.8 Hours

Core Tip

Core Tip: Novel investigational agents targeting functional cure [sustained hepatitis B surface antigen (HBsAg) loss and undetectable hepatitis B virus (HBV) DNA] are currently in clinical trial development. Herein we review key evidence from phases 2 and 3 trials defining the efficacy and safety profiles for key investigational agents, including core/capsid inhibitors, entry inhibitors, RNA interference (siRNA/ASO), HBsAg inhibitors, Toll-like receptor agonists, checkpoint inhibitors, and therapeutic vaccines.