From the Guidelines
The treatment of hepatitis B typically involves antiviral therapy with medications such as entecavir (0.5-1mg orally once daily) or tenofovir disoproxil fumarate (300mg orally once daily), administered for a minimum of 12 months and often indefinitely 1.
Treatment Options
- Entecavir and tenofovir are preferred first-line treatments due to their high efficacy and safety profile 1.
- Interferon-alpha (5 million units subcutaneously three times weekly) may be used for a finite duration of 12-24 months in selected patients 1.
Special Considerations
- Patients with cirrhosis or liver decompensation may require liver transplantation 1.
- All patients should receive hepatitis A vaccination and be screened for hepatocellular carcinoma 1.
Treatment Goals
- The primary goal of treatment is to suppress HBV replication and prevent disease progression 1.
- HBsAg loss is a desirable outcome, but occurs in only a minority of patients 1.
Monitoring and Follow-up
- Patients should be monitored for therapy response and adherence 1.
- Liver fibrosis and HCC risk should be assessed regularly 1.
From the FDA Drug Label
Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older. The recommended dosage of tenofovir disoproxil fumarate tablets in adults and pediatric patients weighing at least 35 kg is one 300 mg tablet taken orally once daily without regard to food.
The treatment for Hepatitis B (HBV) is tenofovir disoproxil fumarate administered orally once daily. The recommended dosage is:
- One 300 mg tablet for adults and pediatric patients weighing at least 35 kg
- Dosage for pediatric patients 2 years and older weighing between 17 kg and 35 kg is provided in the dosage table 2
From the Research
Treatment Options for Hepatitis B (HBV)
The treatment for HBV aims to prevent cirrhosis, liver decompensation, and hepatocellular carcinoma by suppressing HBV replication. The following are the treatment options:
- Interferon-α (IFNα) and nucleos(t)ide analogues (NAs) are approved medications for the treatment of chronic HBV infection 3.
- IFNα is suitable for young patients with less advanced liver diseases and those infected with HBV genotype A 3.
- NAs, such as lamivudine, adefovir dipivoxil, telbivudine, entecavir, and tenofovir disoproxil fumarate, are typically implemented for patients with more advanced liver diseases 3.
- Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are first-line therapies for NA-naive patients with decompensated cirrhosis due to their potent and prompt HBV suppressive effect and low rate of drug-resistant mutations 4.
Patient Selection for Treatment
The following patients should be treated:
- Those with life-threatening liver disease 5.
- Those with high levels of HBV replication and active or advanced liver disease 5.
- 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 6.
- Patients with compensated or decompensated cirrhosis, even if alanine aminotransferase levels are normal and/or serum HBV DNA levels are low 6.
Treatment Monitoring and Management
- Treatment response should be closely monitored to detect virologic breakthroughs 3, 5.
- The importance of medication adherence should be emphasized 3, 5.
- Management of patients with treatment failure should be tailored according to the type of treatment failure, the treatment that the patient is receiving, history of prior treatment, and the pretreatment characteristics of both the patient and the disease 5.