Treatment of Chronic Hepatitis B in HBsAg-Positive, HBeAg-Positive Patients with HBV DNA >10,000,000 IU/mL, Normal ALT, and Age >40 or Liver Fibrosis/Inflammation

Clinical Scenario

This protocol covers adults with chronic hepatitis B who are HBsAg-positive and HBeAg-positive, without cirrhosis, and present in the immune-tolerant phase: HBV DNA greater than 10,000,000 IU/mL with normal ALT levels. Treatment is indicated when at least one of the following is also present:

• Age over 40 years
• Significant liver inflammation — grade 2 or higher on biopsy or non-invasive testing
• Liver fibrosis of F2 or greater on biopsy or non-invasive testing

Treatment Approach

Despite the absence of elevated ALT, the combination of very high viral replication and age or histological findings supports antiviral intervention. The protocol involves oral antiviral therapy using a nucleos(t)ide analogue — one of three established agents in this class.

The specific agent selection, decision criteria, and full structured regimen are available in the complete protocol below.