# Biomarkers of Replication and Injury in HBV/HIV

> **NIH NIH R21** · UNIVERSITY OF CINCINNATI · 2021 · $236,658

## Abstract

Abstract
Hepatitis B virus (HBV) is a serious global health concern. In those with HIV it is associated with
increased risk of chronicity after acute infection, and increased rates of liver-associated
mortality. The field of HBV treatment is undergoing evolution, changing focus from HBV DNA
suppression to functional and complete HBV cure. Biomarkers that provide clear guidance
regarding prediction, treatment outcome and accurate information regarding liver injury are
limited. Though research use of newer HBV biomarkers including pgRNA, quantitative surface
antigen and HBV core-related antigen has accelerated in the last year, very limited data exists
with regard to their use and utility among persons living with HIV (PLWH). In this Exploratory
R21 application we propose to evaluate the potential role of several biomarkers that have not
been previously characterized in those with HBV/HIV coinfection. HBV pgRNA represents a
transcript of the cccDNA minichromosome that is central to development and perpetuation of
HBV chronicity. Using 3 complementary cohorts of PLWH, we will evaluate the association of
these biomarkers with CD4 count, HIV viral load and other demographic and serologic HBV
markers stratified by categorical natural history replicative stages of HBV disease. In one AIDS
Clinical Trials Group (ACTG) cohort, we will examine longitudinal changes in these biomarkers
associated with initiation of nucleoside therapy. Our laboratory has recently implemented use of
a new blood-based cccDNA assay which will be utilized in conjunction with the pgRNA assays
to determine the frequency and proportion of gene silencing. Using novel liver-derived exosome
markers of liver injury we will explore whether gene silencing is associated with lower levels of
liver injury than are identified with more traditional markers of response such as serum ALT.
This characterization will provide key information that may inform future cure strategies for HBV,
in PLWH which are being studied within the ACTG and elsewhere.

## Key facts

- **NIH application ID:** 10326569
- **Project number:** 1R21AI165171-01
- **Recipient organization:** UNIVERSITY OF CINCINNATI
- **Principal Investigator:** KENNETH E SHERMAN
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $236,658
- **Award type:** 1
- **Project period:** 2021-07-12 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10326569

## Citation

> US National Institutes of Health, RePORTER application 10326569, Biomarkers of Replication and Injury in HBV/HIV (1R21AI165171-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10326569. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*