From the Guidelines
Chronic hepatitis B should be monitored and not treated in patients who are in the immune tolerant or inactive carrier phases of the disease, specifically those with normal liver enzymes (ALT) and high or low viral loads, depending on their HBeAg status. These patients should receive regular monitoring every 3-6 months with liver function tests and HBV DNA levels, and annual assessment for hepatocellular carcinoma with ultrasound for those at higher risk (over 40 years, male gender, family history of liver cancer, or cirrhosis) 1. The rationale for observation is that in these phases, there is minimal liver inflammation and damage occurring despite viral presence, and the risks of long-term antiviral therapy (resistance, side effects, cost) may outweigh benefits. However, monitoring is essential as disease status can change, and approximately 20-30% of patients in the immune tolerant phase will eventually progress to active disease requiring treatment. Key factors to consider in the decision to monitor rather than treat include:
- HBeAg status
- ALT levels
- HBV DNA levels
- Presence of liver fibrosis or cirrhosis
- Patient age and risk factors for hepatocellular carcinoma If ALT becomes elevated, HBV DNA increases significantly, or there is evidence of liver fibrosis on biopsy or non-invasive testing, treatment should be initiated promptly with antivirals such as entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide 1. It is also important to note that the goal of therapy for CHB is to eliminate or significantly suppress HBV replication and thus prevent progression of liver disease to cirrhosis, liver failure, or HCC, and that the primary aim of treatment should be to reduce and maintain serum HBV DNA at the lowest possible levels (ie, achieve durable HBV DNA suppression) 1. In terms of specific monitoring and treatment strategies, the following are recommended:
- HBeAg-positive patients with normal ALT and HBV DNA < 2000 IU/mL should be monitored every 6-12 months 1
- HBeAg-positive patients with elevated ALT and HBV DNA > 2000 IU/mL should be considered for treatment with entecavir, tenofovir, or peginterferon alfa-2a 1
- HBeAg-negative patients with normal ALT and HBV DNA < 2000 IU/mL should be monitored every 6-12 months 1
- HBeAg-negative patients with elevated ALT and HBV DNA > 2000 IU/mL should be considered for treatment with entecavir, tenofovir, or peginterferon alfa-2a 1.
From the Research
Monitoring and Treatment of Chronic Hepatitis B (CHB)
- CHB patients with low viral load and normal alanine aminotransferase (ALT) levels may not require antiviral treatment, but should be monitored regularly 2, 3, 4
- Patients in the immune tolerance phase with high viral replication and normal ALT levels are generally not recommended for treatment, but should be closely monitored with serial ALT and HBV DNA measurements 5
- The decision to treat or monitor CHB patients depends on various factors, including:
- HBV DNA levels: treatment is recommended for patients with HBV DNA levels ≥ 10^4 copies/mL (2,000 IU/mL) for HBeAg-negative patients and ≥ 10^5 copies/mL (20,000 IU/mL) for HBeAg-positive patients 3, 4
- ALT levels: treatment is recommended for patients with elevated ALT levels 3, 4
- Liver biopsy and fibrosis assessment: may be helpful in determining the therapeutic strategy, especially in patients with normal or mildly elevated ALT levels 6
- Age and individual risk factors: treatment may be recommended for older patients (> 40 years) or those with advanced histological lesions 5
- Specific subgroups of immunotolerant patients may require treatment, including:
- Patients receiving immunosuppressive treatment or chemotherapy
- Women with high HBV DNA levels during pregnancy
- Healthcare professionals with high viraemia levels 5