Association Between Severe Serum Alanine Aminotransferase Flares and Hepatitis B e Antigen Seroconversion and HBV DNA...

Area of Science:

• Hepatology
• Virology
• Public Health

Background:

• Chronic hepatitis B virus (HBV) infection affects a diverse population in North America.
• Alanine aminotransferase (ALT) flares are a significant event in HBV natural history.
• Data on ALT flare incidence and outcomes in large, heterogeneous North American cohorts are limited.

Purpose of the Study:

• To determine the incidence and outcomes of ALT flares in a large, racially diverse cohort of untreated adults with chronic HBV infection in North America.
• To identify factors associated with ALT flares during HBV infection.
• To assess the relationship between ALT flares and viral markers.

Main Methods:

• An observational cohort study of 1587 untreated adults with chronic HBV infection was conducted across 21 sites in the US and Canada.
• Data were collected over 5 years, with ALT flares defined as ALT levels at least 10 times the upper limit of normal.
• Multivariable analysis was used to identify factors associated with ALT flares and their outcomes.

Main Results:

• The 4-year cumulative incidence of ALT flares was 5.7%, with flares occurring in 6% of participants.
• Factors associated with ALT flares included male sex, higher baseline HBV DNA, at-risk alcohol use, and higher FIB-4 values.
• Older age was associated with lower odds of ALT flares.
• ALT flares were associated with greater decreases in HBV DNA and HBeAg loss, but not HBsAg loss.

Conclusions:

• Severe ALT flares are infrequent in a large, diverse North American cohort of chronic HBV patients.
• ALT flares are linked to improved viral kinetics, including HBV DNA reduction and HBeAg loss.
• No severe adverse hepatic events were observed in patients experiencing ALT flares.