Year 2025 / Volume 117 / Number 11
Original
Serum hepatitis B virus RNA as a predictive biomarker for HBeAg seroconversion during entecavir and tenofovir disoproxil fumarate therapy in chronic hepatitis B patients

645-653

DOI: 10.17235/reed.2025.11226/2025

Shu Wu, Huiling Kang, Er Huang, Wennan Wu, Lijuan Liu, Ronghua Chen,

Abstract
Background and aim: chronic hepatitis B (CHB) affects millions globally and is a leading cause of liver cirrhosis and hepatocellular carcinoma. Nucleos(t)ide analogues (NAs) such as entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are effective in suppressing hepatitis B virus (HBV) replication. However, functional cure, defined by hepatitis B surface antigen (HBsAg) clearance, remains challenging. Reliable biomarkers are needed to predict treatment outcomes. Methods: this study retrospectively analyzed 293 hepatitis B e antigen (HBeAg) positive CHB patients undergoing TDF or ETV treatment. Serum HBsAg, HBeAg, HBV DNA, and HBV RNA levels were measured at baseline and every six months during 24 months. Kaplan-Meier and Cox regression analyses were performed to evaluate the relationship between HBV RNA levels and HBeAg seroconversion. Results: HBeAg seroconversion occurred in 129 patients, with a median time of 14 months. Lower baseline and six-month HBV RNA levels were associated with higher seroconversion rates. Multivariate analysis confirmed HBV RNA as an independent predictor of seroconversion. Receiver operating characteristic (ROC) analysis showed that HBV RNA levels outperformed other markers to predicting outcome, with the combined use of baseline and six-month levels achieving the highest predictive accuracy. Conclusion: HBV RNA is a promising biomarker to predict HBeAg seroconversion during NAs therapy. Its use could enhance personalized treatment strategies for CHB patients.
Lay Summary
Chronic hepatitis B (CHB) is a serious liver disease affecting millions of people worldwide, often leading to liver damage and even liver cancer. Current antiviral treatments, such as entecavir (ETV) and tenofovir disoproxil fumarate (TDF), help control the virus but rarely lead to a complete cure. Therefore, better ways are needed to predict how well a patient will respond to treatment. In this study, we analyzed data from 293 patients with CHB who were receiving ETV or TDF treatment. We focused on a specific blood marker called HBV RNA and examined its relationship with a key milestone in treatment—HBeAg seroconversion, which indicates a favorable immune response. Our findings showed that lower levels of HBV RNA at the start of treatment and after six months were associated with a higher chance of HBeAg seroconversion. This means that measuring HBV RNA levels can help doctors predict which patients are more likely to respond well to treatment. By using this information, treatment plans can be better tailored to individual patients, potentially improving long-term outcomes for people living with CHB.
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Wu S, Kang H, Huang E, Wu W, Liu L, Chen R, et all. Serum hepatitis B virus RNA as a predictive biomarker for HBeAg seroconversion during entecavir and tenofovir disoproxil fumarate therapy in chronic hepatitis B patients. 11226/2025


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Publication history

Received: 21/03/2025

Accepted: 07/06/2025

Online First: 27/06/2025

Published: 11/11/2025

Article revision time: 72 days

Article Online First time: 98 days

Article editing time: 235 days


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