From the Guidelines
Treatment for Hepatitis B (HBV) infection is recommended for patients with chronic HBV infection who have HBV DNA ≥ 2,000 IU/ml, elevated ALT and/or at least moderate histological lesions, while all cirrhotic patients with detectable HBV DNA should be treated. The goal of therapy is to improve survival and quality of life by preventing disease progression, and consequently hepatocellular carcinoma (HCC) development, as stated in the EASL 2017 clinical practice guidelines on the management of HBV infection 1.
Key Indications for Treatment
- Chronic HBV infection with HBV DNA ≥ 2,000 IU/ml, elevated ALT and/or at least moderate histological lesions
- All cirrhotic patients with detectable HBV DNA
- Prevention of mother to child transmission in pregnant women with high viremia
- Prevention of HBV reactivation in patients requiring immunosuppression or chemotherapy
First-Line Treatment Options
- Entecavir, a potent nucleos(t)ide analogue with high barrier to resistance
- Tenofovir disoproxil or tenofovir alafenamide, which are also potent nucleos(t)ide analogues with high barrier to resistance
- Pegylated interferon-alfa treatment can also be considered in mild to moderate chronic hepatitis B patients, as per the guidelines 1
Monitoring and Follow-Up
- Regular monitoring of liver function, viral load, and potential medication side effects is essential during treatment
- All patients should be monitored for risk of disease progression and HCC
- Treated patients should be monitored for therapy response and adherence, as HCC remains the major concern for treated chronic hepatitis B patients 1
From the FDA Drug Label
INDICATIONS AND USAGE Adefovir Dipivoxil Tablets are nucleotide analogues indicated for the treatment of chronic hepatitis B in patients 12 years of age and older. ( 1) DOSAGE AND ADMINISTRATION One tablet containing 10 mg adefovir dipivoxil once daily orally with or without food. ( 2.1)
The treatment criteria for Hepatitis B (HBV) infection using adefovir dipivoxil tablets are:
- Indication: Chronic hepatitis B in patients 12 years of age and older
- Dosage: 10 mg once daily orally with or without food
- Key considerations:
- Monitor hepatic function closely in patients who discontinue treatment
- Monitor renal function during therapy, particularly in patients with pre-existing or other risks for renal impairment
- Offer HIV testing to all patients prior to initiating treatment
- Consider modifying treatment if serum HBV DNA remains above 1000 copies/mL with continued treatment 2
From the Research
Treatment Criteria for Hepatitis B (HBV) Infection
The treatment criteria for HBV infection involve the use of nucleos(t)ide analogs (NAs) and pegylated interferon. The following are key points to consider:
- Five NAs are approved for the treatment of chronic hepatitis B (CHB) infection: lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV), and tenofovir disoproxil fumarate (TDF) 3, 4, 5, 6.
- ETV and TDF are recommended as first-line treatment options due to their excellent tolerability, antiviral potency, and high genetic barrier to resistance 3, 4, 5, 6.
- Pegylated interferon is an immune-modulatory agent that can be used for a finite duration without inducing drug resistance, but it has limited efficacy and is associated with adverse effects such as bone marrow suppression and exacerbation of existing neuropsychiatric symptoms 4, 5.
- The treatment of CHB infection typically requires long-term administration of NAs, with the goal of suppressing HBV DNA replication and improving liver inflammation and fibrosis 3, 4, 7, 5, 6.
- The choice of treatment should be individualized based on the patient's disease severity, liver function, and other factors, with consideration of the potential risks and benefits of each treatment option 4, 7, 5.
Treatment Strategies
Different treatment strategies are being explored, including:
- The "treat-all" strategy, which advocates for early and lifelong antiviral therapy to minimize the risk of hepatocellular carcinoma (HCC) and HBV transmission 7.
- The "stop" strategy, which involves stopping NA therapy in patients with HBeAg-negative disease after long-term viral suppression, with the goal of achieving long-term immune control and potentially HBsAg loss off treatment 7.
- Combination therapy, response-guided therapy, and the roadmap concept are also being explored as potential strategies to improve treatment efficacy and avoid resistance 6.
Key Considerations
When treating HBV infection, the following key considerations should be kept in mind:
- The risk of drug resistance is a major concern with NA therapy, and the use of potent agents with high genetic barriers to resistance is recommended 3, 4, 5, 6.
- Long-term treatment is typically required, and patients should be monitored regularly for adverse effects and treatment efficacy 3, 4, 7, 5, 6.
- The treatment of HBV infection should be individualized based on the patient's disease severity, liver function, and other factors, with consideration of the potential risks and benefits of each treatment option 4, 7, 5.