Editorial
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Sep 27, 2024; 16(9): 1199-1205
Published online Sep 27, 2024. doi: 10.4254/wjh.v16.i9.1199
Functional cure of chronic hepatitis B-hope or hype?
Gautam Ray
Gautam Ray, Gastroenterology Unit, Department of Medicine, B.R.Singh Hospital, Kolkata 700014, West Bengal, India
Author contributions: Ray G designed the overall concept and outline of the manuscript along with the writing, literature review, discussion and illustration.
Conflict-of-interest statement: No conflict of interest to declare.
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: Gautam Ray, DNB, MD, Additional Chief Health Director, Gastroenterology Unit, Department of Medicine, B.R.Singh Hospital, Sealdah, Kolkata 700014, West Bengal, India. gautam1910@yahoo.com
Received: May 14, 2024
Revised: August 25, 2024
Accepted: September 2, 2024
Published online: September 27, 2024
Processing time: 131 Days and 20.8 Hours
Abstract

Chronic hepatitis B constitutes a substantial disease burden worldwide. The steps advocated by the World Health Organization in 2016 to eradicate hepatitis B by 2030 has failed to achieve significant progress, especially with respect to immunization coverage and linkage to care. The lack of governmental and public awareness regarding the long-term implications of hepatitis B burden cause underfunding of developmental projects. The presently approved treatment modalities have limited efficacy in complete viral eradication, hence the need for newer molecules to achieve functional cure (sustained undetectable hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA in peripheral blood after a finite period of therapy). However, preliminary results from trials of novel therapies show their inadequacy to achieve this end by themselves but better performance with a low baseline serum HBsAg with nucleos(t)ide analogues (NA) treatment which need to be combined with/without pegylated interferon as an immunomodulator. Such therapy is limited by cost and adverse events and need to show incremental benefit over the standard of care (long-term NA therapy) with respect to efficacy and drug toxicities, making the development process tenuous. Thus, while such therapies continue to be tested, strategies should still focus on prevention of transmission by non-pharmaceutical measures, vaccination and increasing linkage to care.

Keywords: Hepatitis B; Drugs; Clinical trial; Therapy; Novel therapies; Functional cure

Core Tip: Due to underperformance of the World Health Organization policy of 2016 to eliminate hepatitis B by 2030, the disease burden remains substantial and there is an unmet need for newer curative therapies due to the inability of the presently approved therapies to completely eradicate the virus. Many novel molecules are in Phase I/II trials but only a few have shown preliminary encouraging results only in combination with pegylated interferon and/or nucleos(t)ide analogues with the risk of adverse events. As drug development will be a lengthy process, the present emphasis should still be on improving preventive measures such as vaccination, increasing diagnosis and linkage to care.