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Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection

Published on: December 15, 2023

HBV serum RNA kinetics during nucleic acid polymers based therapy predict functional cure.

Leeor Hershkovich¹, Scott J Cotler¹, Louis Shekhtman²

¹Program for Experimental & Theoretical Modeling, Division of Hepatology, Department of Medicine, Stritch School of Medicine, Loyola University Chicago, Maywood, IL, USA.

Antiviral Research

|December 20, 2024

Summary

Serum HBV-RNA levels track hepatitis B virus cccDNA activity. Shorter HBV RNA half-life predicts successful functional cure after combination therapy with tenofovir-disoproxil-fumarate and pegylated-interferon-alpha-2a.

Keywords:

Functional cure HBV RNA Hepatitis B virus Nucleic-acid polymers TDF pegIFN

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Analysis of HBV-Specific CD4 T-cell Responses and Identification of HLA-DR-Restricted CD4 T-Cell Epitopes Based on a Peptide Matrix

Published on: October 20, 2021

Area of Science:

Hepatology
Virology
Pharmacology

Background:

Serum HBV RNA is a marker for cccDNA transcriptional activity in hepatocytes.
Combination therapy of tenofovir-disoproxil-fumarate (TDF) and pegylated-interferon-alpha-2a (pegIFN) with nucleic-acid polymer (NAP) shows promise for functional cure in chronic HBV.
Understanding HBV RNA kinetics is crucial for optimizing treatment strategies.

Purpose of the Study:

To characterize HBV RNA kinetics during combination therapies involving TDF and pegIFN, with or without NAP.
To investigate the relationship between HBV RNA kinetic patterns and treatment outcomes, including functional cure.
To assess the predictive value of early HBV RNA levels for treatment response.

Main Methods:

A phase-II clinical trial (REP401) involving 40 participants with chronic HBV.
Participants received 48 weeks of triple combination therapy (TDF + pegIFN + NAPs) or sequential TDF/dual therapy followed by triple therapy.
HBV RNA levels were measured every 4 weeks using the Abbott RUO assay.

Main Results:

Novel HBV RNA kinetic patterns were observed, including stable levels, new plateaus, and transient increases followed by declines.
Introduction of NAPs led to a decline in HBV RNA in participants with elevated plateaus.
Failure to reach the lower limit of quantification (LLoQ) for HBV RNA by 16 weeks predicted functional cure with 100% accuracy.
A significantly longer HBV RNA half-life was observed in the virological rebound group compared to partial and functional cure groups (5.7 vs. 2.7 weeks).

Conclusions:

HBV RNA kinetics provide valuable insights into cccDNA activity during antiviral therapy.
Early HBV RNA kinetics, particularly the time to reach LLoQ, can predict functional cure.
Shorter HBV RNA half-life is associated with achieving partial or functional cure, suggesting more effective cccDNA inactivation.