What is Hepatitis B (Hepatitis B virus infection)?

From the Guidelines

Hepatitis B treatment should prioritize antiviral medications such as entecavir, tenofovir, or lamivudine to suppress viral replication and reduce liver inflammation, as recommended by the most recent guidelines 1. The goal of treatment is to improve survival and quality of life by preventing disease progression, and consequently, hepatocellular carcinoma (HCC) development.

• Chronic hepatitis B requires long-term administration of a potent nucleos(t)ide analogue with high barrier to resistance, such as entecavir, tenofovir disoproxil, or tenofovir alafenamide.
• Pegylated interferon-alfa treatment can also be considered in mild to moderate chronic hepatitis B patients.
• Combination therapies are not generally recommended.
• All patients should be monitored for risk of disease progression and HCC.
• Treated patients should be monitored for therapy response and adherence. Key considerations for treatment include:
• HBV DNA levels
• ALT levels
• Histological abnormalities, including inflammation and fibrosis
• Demographic factors
• Prevention of mother-to-child transmission in pregnant women with high viremia
• Prevention of HBV reactivation in patients requiring immunosuppression or chemotherapy Regular monitoring through blood tests is essential to track liver function and viral load, as recommended by recent studies 1. The virus spreads through contact with infected blood or body fluids, including during childbirth, sexual contact, sharing needles, or exposure to contaminated blood. People with hepatitis B should avoid alcohol, maintain a healthy diet, get vaccinated against hepatitis A, and inform sexual partners and household members who should be tested and vaccinated if not immune. Recent data suggest that antiviral treatment can reduce the risk of HCC by 60% to nearly 80% compared to no treatment 1. Therefore, early initiation of antiviral therapy is crucial to prevent disease progression and reduce the incidence of HCC, as supported by the latest evidence 1.

From the FDA Drug Label

In patients who have discontinued anti-Hepatitis B therapy including Adefovir Dipivoxil Tablets, severe acute exacerbations of hepatitis have been reported. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. The safety and efficacy of entecavir were evaluated in three Phase 3 active-controlled trials [see Clinical Studies (14.1,14. 2)] . These studies included 1633 subjects 16 years of age or older with chronic hepatitis B virus infection (serum HBsAg-positive for at least 6 months) accompanied by evidence of viral replication (detectable serum HBV DNA, as measured by the bDNA hybridization or PCR assay). The treatment of hepatitis B is the primary focus of the provided drug labels, with entecavir and adefovir being the mentioned drugs.

• Entecavir was evaluated in three Phase 3 active-controlled trials, which included 1633 subjects with chronic hepatitis B virus infection.
• Adefovir is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease 2. It is essential to monitor hepatic function closely in patients who discontinue anti-Hepatitis B therapy, as severe acute exacerbations of hepatitis have been reported 2.

From the Research

Hepatitis B Treatment

• The goal of antiviral therapy in patients with chronic hepatitis B is to prevent cirrhosis and hepatocellular carcinoma through persistent suppression of HBV replication 3.
• Seven drugs are available for the treatment of chronic hepatitis B: IFN-alpha, pegylated interferon, lamivudine, adefovir dipivoxil, entecavir, telbivudine, and tenofovir 3.
• The choice of treatment should take into consideration the clinical features of patients, antiviral efficacy, risk of developing resistance, long-term safety profile, method of administration, and cost of therapy 3.

Indications for Treatment

• Treatment is indicated in patients with life-threatening liver disease, compensated cirrhosis, and high levels of serum HBV DNA 4.
• Patients with precirrhotic liver disease should be treated based on clinical, biochemical, or histological evidence of liver disease, such as elevated alanine aminotransferase (ALT) levels, abnormal histology, and high levels of serum HBV DNA 4.
• Treatment is generally indicated in chronic hepatitis B patients with HBV DNA >2000 IU/mL, elevated ALT, and/or at least moderate histological lesions 5.

Patient Selection and Treatment Decisions

• The decision to start treatment should be based on careful patient selection and individualized decisions 5.
• Treatment decisions should take into consideration factors such as desire to start a family, occupational requirement, family history of hepatocellular carcinoma, access to care and insurance coverage, and commitment to long-term treatment and medication compliance 4.
• Emerging non-invasive biomarkers of disease activity will further enhance disease stratification and guide treatment decisions 6.

Treatment Options

• Pegylated interferon alfa-2a, entecavir, and tenofovir are recommended as first-line treatment options for chronic hepatitis B 7.
• Prophylactic treatment is indicated in HBV-related liver transplantation patients, in the last trimester of pregnancy in women with high viraemia, and in patients receiving immunosuppression/chemotherapy to prevent the reactivation of HBV 5.