Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications

Hepatitis B virus (HBV) genetic variability, shaped by high mutation rates and selective pressures, complicates its management and increases the emergence of drug-resistant and immune-escape variants. This study aims to analyze immune escape mutations (IEMs) and drug resistance mutations (DRMs) in p...

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Main Authors: Maria Antonia De Francesco, Franco Gargiulo, Francesca Dello Iaco, Laert Zeneli, Serena Zaltron, Giorgio Tiecco, Simone Pellizzeri, Emanuele Focà, Arnaldo Caruso, Eugenia Quiros-Roldan
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Language:English
Published: MDPI AG 2025-04-01
Series:Life
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Online Access:https://www.mdpi.com/2075-1729/15/4/672
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author Maria Antonia De Francesco
Franco Gargiulo
Francesca Dello Iaco
Laert Zeneli
Serena Zaltron
Giorgio Tiecco
Simone Pellizzeri
Emanuele Focà
Arnaldo Caruso
Eugenia Quiros-Roldan
author_facet Maria Antonia De Francesco
Franco Gargiulo
Francesca Dello Iaco
Laert Zeneli
Serena Zaltron
Giorgio Tiecco
Simone Pellizzeri
Emanuele Focà
Arnaldo Caruso
Eugenia Quiros-Roldan
author_sort Maria Antonia De Francesco
collection DOAJ
description Hepatitis B virus (HBV) genetic variability, shaped by high mutation rates and selective pressures, complicates its management and increases the emergence of drug-resistant and immune-escape variants. This study aims to analyze immune escape mutations (IEMs) and drug resistance mutations (DRMs) in patients with HBV infection exposed to antiviral therapies and exhibiting detectable plasma HBV viremia. This monocentric retrospective real-life study was carried out at the ASST Spedali Civili di Brescia, Italy, from 2015 to 2023. A total of 102 consecutive patients with detectable serum HBV-DNA exposed to at least one NA and for whom a drug resistance assay was available were included in our study. HBV sequences were amplified, sequenced, and analyzed for mutations using Geno2pheno and Stanford University tools. Phylogenetic analysis and statistical regression were performed to confirm genotypes and identify mutation patterns and associated risk factors. Our study shows a 38.2% prevalence of DRMs, with M204I/V (95%) and L180M (64%) being the most common, and a 43% prevalence of IEMs, primarily in the major hydrophilic region. Genotype D3 exhibited a higher mutation burden than other genotypes. Significant associations were found between HBsAb presence and increased IEM burden, while HBeAg was protective against DRMs. Atypical serological profiles were observed in 18.6% of patients, including cases of HBV reactivation under immunosuppressive therapy. This study highlights the high prevalence of IEMs and DRMs in a real-world setting, particularly among HBV genotype D3 carriers. These findings underscore the importance of mutation surveillance to guide therapeutic strategies, vaccine design, and public health policies to address the challenges posed by HBV genetic variability.
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spelling doaj-art-3e321b4c76114b60a6887600e8197e842025-08-20T03:13:52ZengMDPI AGLife2075-17292025-04-0115467210.3390/life15040672Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological ImplicationsMaria Antonia De Francesco0Franco Gargiulo1Francesca Dello Iaco2Laert Zeneli3Serena Zaltron4Giorgio Tiecco5Simone Pellizzeri6Emanuele Focà7Arnaldo Caruso8Eugenia Quiros-Roldan9Institute of Microbiology, Department of Molecular and Translational Medicine, University of Brescia-ASST Spedali Civili, 25123 Brescia, ItalyInstitute of Microbiology, Department of Molecular and Translational Medicine, University of Brescia-ASST Spedali Civili, 25123 Brescia, ItalyInstitute of Microbiology, Department of Molecular and Translational Medicine, University of Brescia-ASST Spedali Civili, 25123 Brescia, ItalyUnit of Infectious and Tropical Diseases, Department of Clinical and Experimental Sciences, University of Brescia and ASST Spedali Civili di Brescia, 25123 Brescia, ItalyUnit of Infectious and Tropical Diseases, ASST Spedali Civili di Brescia, 25123 Brescia, ItalyUnit of Infectious and Tropical Diseases, Department of Clinical and Experimental Sciences, University of Brescia and ASST Spedali Civili di Brescia, 25123 Brescia, ItalyDepartment of Clinical and Experimental Sciences, University of Brescia, 25123 Brescia, ItalyUnit of Infectious and Tropical Diseases, Department of Clinical and Experimental Sciences, University of Brescia and ASST Spedali Civili di Brescia, 25123 Brescia, ItalyInstitute of Microbiology, Department of Molecular and Translational Medicine, University of Brescia-ASST Spedali Civili, 25123 Brescia, ItalyUnit of Infectious and Tropical Diseases, Department of Clinical and Experimental Sciences, University of Brescia and ASST Spedali Civili di Brescia, 25123 Brescia, ItalyHepatitis B virus (HBV) genetic variability, shaped by high mutation rates and selective pressures, complicates its management and increases the emergence of drug-resistant and immune-escape variants. This study aims to analyze immune escape mutations (IEMs) and drug resistance mutations (DRMs) in patients with HBV infection exposed to antiviral therapies and exhibiting detectable plasma HBV viremia. This monocentric retrospective real-life study was carried out at the ASST Spedali Civili di Brescia, Italy, from 2015 to 2023. A total of 102 consecutive patients with detectable serum HBV-DNA exposed to at least one NA and for whom a drug resistance assay was available were included in our study. HBV sequences were amplified, sequenced, and analyzed for mutations using Geno2pheno and Stanford University tools. Phylogenetic analysis and statistical regression were performed to confirm genotypes and identify mutation patterns and associated risk factors. Our study shows a 38.2% prevalence of DRMs, with M204I/V (95%) and L180M (64%) being the most common, and a 43% prevalence of IEMs, primarily in the major hydrophilic region. Genotype D3 exhibited a higher mutation burden than other genotypes. Significant associations were found between HBsAb presence and increased IEM burden, while HBeAg was protective against DRMs. Atypical serological profiles were observed in 18.6% of patients, including cases of HBV reactivation under immunosuppressive therapy. This study highlights the high prevalence of IEMs and DRMs in a real-world setting, particularly among HBV genotype D3 carriers. These findings underscore the importance of mutation surveillance to guide therapeutic strategies, vaccine design, and public health policies to address the challenges posed by HBV genetic variability.https://www.mdpi.com/2075-1729/15/4/672HBVescape mutationsdrug resistance mutationsgenotypesvaccinesequence
spellingShingle Maria Antonia De Francesco
Franco Gargiulo
Francesca Dello Iaco
Laert Zeneli
Serena Zaltron
Giorgio Tiecco
Simone Pellizzeri
Emanuele Focà
Arnaldo Caruso
Eugenia Quiros-Roldan
Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications
Life
HBV
escape mutations
drug resistance mutations
genotypes
vaccine
sequence
title Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications
title_full Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications
title_fullStr Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications
title_full_unstemmed Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications
title_short Immune Escape and Drug Resistance Mutations in Patients with Hepatitis B Virus Infection: Clinical and Epidemiological Implications
title_sort immune escape and drug resistance mutations in patients with hepatitis b virus infection clinical and epidemiological implications
topic HBV
escape mutations
drug resistance mutations
genotypes
vaccine
sequence
url https://www.mdpi.com/2075-1729/15/4/672
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