Incidence and determinants of spontaneous hepatitis B surface antigen seroclearance: a community-based follow-up study.

Abstract

BACKGROUND & AIMS:

Seroclearance of hepatitis B surface antigen (HBsAg) is one of the most important clinical outcomes for chronic hepatitis B treatment trials. Few studies have explored the incidence and determinants of spontaneous seroclearance using a long-term follow-up study. This study aimed to examine the natural history and predictors of HBsAg seroclearance.

METHODS:

A total of 3087 individuals with chronic hepatitis B virus infection were enrolled between 1991 and 1992 in this community-based study. Serum samples collected at baseline and follow-up examinations were tested for HBsAg, hepatitis B e antigen (HBeAg), serum hepatitis B virus (HBV)-DNA levels, and anti-hepatitis C virus serostatus. Cox proportional hazards models were used to estimate HBsAg seroclearance rate ratios associated with various determinants.

RESULTS:

HBsAg seroclearance occurred in 562 participants during 24,829 person-years of follow-up evaluation, giving a 2.26% annual seroclearance rate. HBV-DNA levels at baseline and follow-up evaluation were the most significant predictor of seroclearance. Higher HBV viral loads conferred lower HBsAg seroclearance rates (P<.001). A spontaneous decrease in follow-up HBV-DNA level (>or=3 log) was associated significantly with seroclearance, showing an adjusted odds ratio of 4.17 (95% confidence interval, 2.55-6.82). Among those with seroclearance, 95.8% had undetectable HBV-DNA levels before seroclearance. Cumulative incidence of HBsAg seroclearance at 60 and 100 months after serum HBV-DNA level decreased to undetectable was 25.8% and 51.3%, respectively.

CONCLUSIONS:

This study reveals determinants of HBsAg seroclearance, and suggests that a low viral load is an important factor affecting the natural seroclearance of HBsAg, indicating significant clinical implications for the treatment of chronic HBV.

• Authors: Jessica Liu, Hwai-I Yang, Mei-Hsuan Lee, Sheng-Nan Lu, Chin-Lan Jen, Li-Yu Wang, San-Lin You, Uchenna H Iloeje, Chien-Jen Chen, REVEAL-HBV Study Group
• Journal: Gastroenterology (Gastroenterology) Vol. 139 Issue 2 Pg. 474-82 (Aug 2010) ISSN: 1528-0012 [Electronic] United States
• PMID: 20434450 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Biomarkers
• DNA, Viral
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Hepatitis C Antibodies

Topics

• Adult
• Age Factors
• Aged
• Biomarkers (blood)
• DNA, Viral (blood)
• Female
• Follow-Up Studies
• Hepatitis B Surface Antigens (blood)
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (genetics, immunology)
• Hepatitis B, Chronic (diagnosis, drug therapy, epidemiology)
• Hepatitis C Antibodies (blood)
• Humans
• Incidence
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Population Surveillance
• Prognosis
• Proportional Hazards Models
• Prospective Studies
• Risk Assessment
• Risk Factors
• Serologic Tests
• Sex Factors
• Taiwan (epidemiology)
• Time Factors
• Viral Load