Prevalence and Risk Factors of Antiviral Resistance in Egyptian HBV Patients

This study aims to determine the prevalence of antiviral drug resistance among Egyptian patients with chronic hepatitis B virus (HBV) infection and to identify the associated demographic, clinical, and virological risk factors. Understanding patterns of resistance will help improve treatment selection and optimize long-term management strategies for HBV patients.

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Key information

Conditions

Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

This study will include all chronic HBV-infected patients, either cirrhotic or not, receiving TDF 300 mg, ETV 0.5 or 1mg, or lamivudine 100 mg, irrespective of HBeAg status. The HBV chronicity is defined by persistence of HbsAg positivity for more than 6 months.

Exclusion criteria

Patients younger than 18 years old.

Treatment and study plan

Primary outcomes

Proportion of Patients Exhibiting Antiviral Resistance Detection of HBV Antiviral Resistance Mutations

Time frame: 6 months

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Sponsors and collaborators

Lead sponsor

Amira Mohamed Zidan

Other

Registry information

Official study title

Prevalence and Risk Factors Associated With Resistance to Antiviral Therapy in Egyptian Patients With Chronic Hepatitis B Virus Infection

Acronym: PRARE-CHB

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Dec 10, 2025
Registry last updated: Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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