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Immunological Biomarker Discovery in Cure Regimens for Chronic Hepatitis B Virus Infection

Gehring, Adam J; Mendez, Patricia; Richter, Kirsten; Ertl, Hildegund; Donaldson, Eric F; Mishra, Poonam; Maini, Mala; ... Miller, Veronica; + view all (2022) Immunological Biomarker Discovery in Cure Regimens for Chronic Hepatitis B Virus Infection. Journal of Hepatology , 77 (2) pp. 525-538. 10.1016/j.jhep.2022.02.020. Green open access

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Abstract

There have been unprecedented advances in identifying new targets for chronic hepatitis B therapy to achieve functional cure in patients who would otherwise face lifelong nucleoside analogue treatment. Many of the new investigational therapies either directly target the immune system or are anticipated to impact immunity indirectly through modulation of the viral lifecycle and antigen production. While new viral biomarkers (HBV RNA, HBcAg, small, middle, large HBs isoforms) are proceeding through validation steps in clinical studies, immunological biomarkers are non-existent outside of clinical assays for antibodies to HBs, and HBe. To develop clinically applicable immunological biomarkers to measure mechanisms of action, inform logical combination strategies, and guide clinical management for use and discontinuation of immune-targeting drugs, immune assays must be incorporated into Phase I/II clinical trials. This paper will discuss the importance of sample collection, the assays available for immunological analyses, their advantages/disadvantages and suggestions for their implementation in clinical trials. Careful consideration must be given to ensure appropriate immunological studies are included as a primary component of the trial with deeper immunological analysis provided by ancillary studies. Standardizing immunological assays and data obtained from clinical trials will identify biomarkers that can be deployed in the clinic, independent of specialized immunology laboratories.

Type: Article
Title: Immunological Biomarker Discovery in Cure Regimens for Chronic Hepatitis B Virus Infection
Location: Netherlands
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jhep.2022.02.020
Publisher version: https://doi.org/10.1016/j.jhep.2022.02.020
Language: English
Additional information: Copyright © 2022 The Authors. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Hepatitis B, clinical trial, drug development, immunology, therapy, viral hepatitis
UCL classification: UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10147938
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