What is the management of Hepatitis B (HBV) infection?

From the Guidelines

The management of hepatitis B requires a comprehensive approach with antiviral therapy as the mainstay of treatment, aiming to suppress viral replication, reduce inflammation, and prevent progression to cirrhosis and hepatocellular carcinoma, as recommended by the EASL 2017 clinical practice guidelines 1.

Key Considerations

• The goal of therapy is to improve survival and quality of life by preventing disease progression, and consequently HCC development.
• The induction of long-term suppression of HBV replication represents the main endpoint of current treatment strategies, while HBsAg loss is an optimal endpoint.
• Treatment is typically long-term, often lifelong, as discontinuation can lead to viral rebound and hepatic flares.

Treatment Recommendations

• First-line treatments include entecavir (0.5 mg daily) or tenofovir disoproxil fumarate (300 mg daily), which have high barriers to resistance and excellent safety profiles, as recommended by the EASL 2017 clinical practice guidelines 1.
• Pegylated interferon-alfa treatment can also be considered in mild to moderate chronic hepatitis B patients.
• Combination therapies are not generally recommended.

Patient Monitoring

• Regular monitoring includes liver function tests every 3-6 months, HBV DNA levels every 6-12 months, and annual surveillance for hepatocellular carcinoma with ultrasound in high-risk patients.
• Patients with decompensated cirrhosis require urgent antiviral therapy and evaluation for liver transplantation.

Special Considerations

• Pregnant women with high viral loads (>200,000 IU/mL) should receive tenofovir in the third trimester to prevent vertical transmission, as recommended by the EASL 2017 clinical practice guidelines 1.
• All newborns of HBsAg-positive mothers need hepatitis B immunoglobulin and vaccination within 12 hours of birth.
• Lifestyle modifications include avoiding alcohol, maintaining healthy weight, and preventing transmission to others through safe sex practices and avoiding blood exposure.

From the FDA Drug Label

PEGASYS is an inducer of the innate immune response indicated for the treatment of ... Chronic Hepatitis B (CHB) (1. 2) Adult Patients: Treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) infection who have compensated liver disease and evidence of viral replication and liver inflammation In adult patients with CHB, PEGASYS is dosed as 180 mcg per week for 48 weeks (2. 4). Pediatric Patients: Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive CHB and evidence of viral replication and elevations in serum alanine aminotransferase (ALT) In pediatric patients with CHB, PEGASYS is dosed as 180 mcg/1.73 m2 × BSA per week for 48 weeks (2. 5)

Management of Hepatitis B

• PEGASYS is indicated for the treatment of chronic hepatitis B (CHB) in adults and pediatric patients.
• The recommended dose for adults with CHB is 180 mcg per week for 48 weeks.
• The recommended dose for pediatric patients with CHB is 180 mcg/1.73 m2 × BSA per week for 48 weeks.
• Treatment is recommended for patients with compensated liver disease, evidence of viral replication, and liver inflammation.
• Patients should be closely monitored for signs of hepatic decompensation and other adverse reactions. 2

From the Research

Treatment Options for Hepatitis B

• The treatment of chronic hepatitis B includes monotherapy with either interferons (IFNs) or nucleos(t)ide (NUC) analogs 3.
• Available drugs for the treatment of chronic hepatitis B include recombinant interferons, such as interferon-α and its pegylated formulation, and the nucleos(t)ide analogues, such as lamivudine, adefovir, telbivudine, entecavir, and tenofovir 4.
• Pegylated-interferon is an immune-modulatory agent that works mainly by enhancing the innate immune response, while nucleos(t)ide analogues are oral drugs with direct inhibition of viral replication 4.

Choice of Treatment

• The choice of treatment should take into consideration the clinical features of patients, the antiviral efficacy of each drug, the risk of developing resistance, the long-term safety profile, the method of administration, and the cost of therapy 5.
• 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 5.
• Patients with compensated or decompensated cirrhosis should be treated, even if alanine aminotransferase levels are normal and/or serum HBV DNA levels are low, in order to prevent disease flare and to improve liver function 5.

Efficacy and Safety of Treatment

• Long-term viral suppression is associated with regression of liver fibrosis and reduced risk of hepatocellular carcinoma in cohort studies 6.
• Newer agents (entecavir, tenofovir disoproxil, and tenofovir alafenamide) may be associated with a significantly reduced risk of drug resistance compared with older agents (lamivudine and adefovir) and should be considered as the first-line treatment 6.
• Nucleos(t)ide analogs should be considered as first-line therapy because they are better tolerated and provide excellent viral suppression with a low risk of antiviral resistance 7.

Duration of Treatment

• Pegylated interferon therapy can be completed in 48 weeks and is not associated with the development of resistance 6.
• Prolonged treatment is usually needed with oral antiviral agents, and relapse is common if treatment is discontinued 7.
• Most patients will require therapy indefinitely because cure rates are low 6.