From the Guidelines
For patients with hepatitis B e antigen, treatment is typically recommended when ALT levels are elevated and HBV DNA is ≥ 2,000 IU/mL, with first-line treatment options including entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide, which are potent antiviral medications with high barriers to resistance 1.
Key Considerations
- The primary goal of treatment is to eliminate or significantly suppress HBV replication, thereby preventing progression of liver disease to cirrhosis, liver failure, or hepatocellular carcinoma (HCC) 1.
- Treatment duration depends on achieving HBeAg seroconversion, which indicates immune control of the virus, and after seroconversion, treatment should continue for at least 12 months before considering discontinuation 1.
- Regular monitoring of liver function, HBV DNA levels, and HBeAg status is essential during treatment to assess response and detect potential complications 1.
Treatment Options
- Entecavir (0.5 mg daily) is a potent antiviral medication with a high barrier to resistance, and is a first-line treatment option for patients with hepatitis B e antigen 1.
- Tenofovir disoproxil fumarate (300 mg daily) and tenofovir alafenamide (25 mg daily) are also first-line treatment options, with high barriers to resistance and potent antiviral activity 1.
- Pegylated interferon-alfa treatment can also be considered in mild to moderate chronic hepatitis B patients, although it is not generally recommended as a first-line treatment option 1.
Monitoring and Follow-up
- Patients should be monitored for risk of disease progression and HCC, and treated patients should be monitored for therapy response and adherence 1.
- Regular monitoring of liver function, HBV DNA levels, and HBeAg status is essential during treatment to assess response and detect potential complications 1.
From the FDA Drug Label
At Week 48, improvement was seen with respect to mean change in serum HBV DNA (log 10 copies/mL), normalization of ALT, and HBeAg seroconversion as compared to placebo in patients receiving Adefovir Dipivoxil Tablets (Table 6)
- HBeAg seroconversion was observed in 12% of patients treated with Adefovir Dipivoxil Tablets in Study 437.
- The effect of continued treatment with Adefovir Dipivoxil Tablets on seroconversion is unknown. The FDA drug label does provide some information on HBeAg seroconversion in patients treated with adefovir dipivoxil, but it does not provide a clear answer to the question of the relationship between hepatitis B little e antigen and hepatitis B treatment. However, based on the available information,
- HBeAg seroconversion can occur in some patients treated with adefovir dipivoxil.
- The clinical relevance of this seroconversion is not fully understood and more research is needed to determine its significance 2.
From the Research
Hepatitis B Treatment Options
- The treatment of chronic hepatitis B (CHB) can be classified into interferon-α (IFN) and nucleos(t)ide analogues (NAs) 3, 4, 5.
- NAs are currently used in most CHB patients due to their excellent tolerability, good safety profile, and high potency in suppressing HBV DNA 3, 4, 5.
- The current first-line NA options, entecavir (ETV) and tenofovir (TDF), have minimal risk of resistance during long-term monotherapy and can achieve high virological remission rates in adherent HBeAg-positive patients 3, 4, 5.
HBeAg Seroconversion
- HBeAg seroconversion is an important goal in the treatment of patients with HBeAg-positive CHB, and is associated with reduced incidence of hepatic complications and improved survival rates 6.
- Treatment with pegylated interferon (PegIFN)-alpha is associated with higher and more durable HBeAg seroconversion rates than lamivudine and adefovir 6.
- Newer generation oral NAs, such as entecavir, telbivudine, and tenofovir, demonstrate superior antiviral potency and efficacy in achieving HBeAg seroconversion 6, 7.
Safety and Efficacy of NAs
- NAs have been shown to be effective in achieving HBeAg seroconversion, HBeAg loss, and undetectable HBV DNA, with a good safety profile and minimal risk of serious adverse events 7.
- Telbivudine was associated with higher HBeAg seroconversion compared with entecavir, while tenofovir ranked as the best for HBeAg loss rate and proportion of achieving undetectable HBV DNA 7.
- Entecavir might be the most potent in the normalization of alanine aminotransferase (ALT) 7.