From the Guidelines
The recommended treatment for chronic Hepatitis B typically involves antiviral medications, with first-line options including entecavir (0.5-1mg daily) or tenofovir (either tenofovir disoproxil fumarate 300mg daily or tenofovir alafenamide 25mg daily) 1. These medications suppress viral replication and are usually taken long-term, often indefinitely, as treatment cessation can lead to viral rebound.
Key Considerations
- Treatment is generally indicated for patients with elevated liver enzymes, high viral load (HBV DNA levels >2,000 IU/mL), significant liver fibrosis or cirrhosis, or those at high risk for liver complications.
- Regular monitoring is essential during treatment, including:
- Liver function tests every 3-6 months
- HBV DNA levels to confirm viral suppression
- Periodic assessment for complications like hepatocellular carcinoma with ultrasound every 6 months in high-risk patients
Mechanism of Action
These antivirals work by inhibiting the viral polymerase, preventing HBV replication and reducing liver inflammation and damage. While they effectively control the virus, they rarely achieve complete cure (elimination of HBsAg) because HBV DNA integrates into the host hepatocyte genome, forming a stable reservoir that current medications cannot eliminate 1.
Choice of Therapy
The choice between entecavir and tenofovir should be based on individual patient factors, including the presence of cirrhosis, renal function, and potential for resistance 1. Peginterferon alfa-2a is also a viable option for some patients, particularly those with a high likelihood of response, such as those with low viral loads and elevated ALT levels 1. However, the use of peginterferon alfa-2a is limited by its injectable route of administration and potential side effects. In general, the treatment of chronic Hepatitis B should be individualized and guided by regular monitoring and assessment of treatment response 1.
From the FDA Drug Label
The recommended dose of Tenofovir disoproxil fumarate tablets in adults and pediatric patients 12 years of age and older (35 kg or more) for the treatment of chronic hepatitis B is one 300 mg tablet once daily taken orally, without regard to food. The optimal duration of treatment is unknown. For the treatment of chronic hepatitis B, the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Tenofovir disoproxil fumarate was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease.
The recommended treatment for chronic Hepatitis B is Tenofovir disoproxil fumarate at a dose of 300 mg once daily for adults and pediatric patients 12 years of age and older (35 kg or more) 2.
- The optimal duration of treatment is unknown.
- Tenofovir disoproxil fumarate is also indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
- Alternatively, Adefovir Dipivoxil Tablets can be used at a dose of 10 mg once daily for patients 12 years of age and older with adequate renal function 3.
From the Research
Treatment Overview
- The goal of antiviral therapy in patients with chronic hepatitis B is to prevent cirrhosis and hepatocellular carcinoma through persistent suppression of HBV replication 4.
- Seven drugs are available for the treatment of chronic hepatitis B: IFN-alpha, pegylated interferon, lamivudine, adefovir dipivoxil, entecavir, telbivudine, and tenofovir 4, 5.
Ideal Candidates for Treatment
- Ideal candidates for treatment are hepatitis B e antigen-positive patients with a prolonged phase of immune clearance and hepatitis B e antigen-negative patients with elevated levels of serum HBV DNA, abnormal alanine aminotransferase, and histologic evidence of moderate or severe liver necroinflammation and/or fibrosis 4.
- Patients with compensated or decompensated cirrhosis should be treated, even if alanine aminotransferase levels are normal and/or serum HBV DNA levels are low, to prevent disease flare and improve liver function 4.
Treatment Options
- The selection of a drug with high potency and low rate of resistance is essential to achieve rapid and long-term viral suppression 5.
- Entecavir, tenofovir, and peginterferon alfa-2a are recommended as initial treatment options 5.
- Entecavir is a valuable first-line option in nucleoside-naive patients with chronic HBV infection and is a useful alternative in lamivudine-refractory patients 6.
Management of Resistance
- The prevention of the sequelae of antiviral drug resistance and appropriate management of viral breakthrough are major goals of current management 5.
- The addition or change to an antiviral agent that is not cross-resistant is critical to restore suppression of viral replication for patients with breakthrough resistance 5.
Current Treatment Guidelines
- Treatment practices for patients with chronic hepatitis B vary across the world, and several professional associations have issued treatment recommendations 7.
- Treatment recommendations are summarized separately for hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients, and are based on a variety of host and viral factors 7.