From the Guidelines
The treatment algorithm for chronic hepatitis B should prioritize the long-term administration of a potent nucleos(t)ide analogue with high barrier to resistance, such as entecavir, tenofovir disoproxil, or tenofovir alafenamide, as recommended by the EASL 2017 clinical practice guidelines 1. The goal of therapy is to improve survival and quality of life by preventing disease progression and hepatocellular carcinoma (HCC) development.
- Key considerations for treatment initiation include:
- HBV DNA levels ≥ 2,000 IU/ml
- Elevated ALT
- At least moderate histological lesions
- All cirrhotic patients with detectable HBV DNA should be treated
- Additional indications for treatment include:
- Prevention of mother to child transmission in pregnant women with high viremia
- Prevention of HBV reactivation in patients requiring immunosuppression or chemotherapy
- Treatment options, as per the guidelines, are:
- Entecavir
- Tenofovir disoproxil
- Tenofovir alafenamide
- Pegylated interferon-alfa for mild to moderate chronic hepatitis B patients
- Monitoring is crucial and should include:
- Liver function tests
- HBV DNA levels to confirm viral suppression
- Hepatocellular carcinoma screening with ultrasound every 6 months for cirrhotic patients or those at high risk, as recommended by the EASL guidelines 1.
From the FDA Drug Label
In Study 115,106 HBeAg negative (9%) and positive (91%) subjects aged 12 to less than 18 years with chronic HBV infection were randomized to receive blinded treatment with tenofovir disoproxil fumarate 300 mg (N=52) or placebo (N=54) for 72 weeks. At Week 72,88% (46/52) of subjects in the tenofovir disoproxil fumarate group and 0% (0/54) of subjects in the placebo group had HBV DNA <400 copies/mL (69 IU/mL).
The algorithm for chronic hepatitis B treatment is not explicitly stated in the provided drug labels. However, based on the information provided, tenofovir disoproxil fumarate can be considered as a treatment option for chronic hepatitis B.
- The treatment regimen for tenofovir disoproxil fumarate is 300 mg once daily.
- The treatment duration is at least 72 weeks.
- The primary endpoint is HBV DNA <400 copies/mL.
- Patients with renal impairment may require dose adjustment.
- Patients co-infected with HIV-1 and HBV should be treated with a higher dose of lamivudine as part of an appropriate combination regimen 2. The safety and effectiveness of tenofovir disoproxil fumarate in pediatric patients younger than 12 years of age or less than 35 kg with chronic hepatitis B have not been established 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 treatment: IFN-alpha, pegylated interferon, lamivudine, adefovir dipivoxil, entecavir, telbivudine, and tenofovir 4.
Patient Selection
- 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
- Antiviral drugs available for treatment include lamivudine, adefovir, entecavir, telbivudine, and tenofovir disoproxil fumarate, which interfere with viral DNA synthesis 5.
- 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 6.
- Second-generation nucleos(t)ide analogues, such as entecavir and tenofovir, have a high genetic barrier to resistance and potent antiviral action 6.
Treatment Algorithm
- A treatment algorithm for managing chronic hepatitis B virus infection has been updated to reflect new developments, including the introduction of tenofovir alafenamide and the increasing availability of hepatitis B surface antigen quantitation 7.
- The algorithm is intended to serve as a guide for managing chronic hepatitis B, taking into account the natural history of the disease, the presence of comorbidities, and the increasing use of biologics associated with aging 7.
Treatment Goals
- The short-term goal of antiviral treatment is to reduce viral DNA below levels of detection, while the long-term goal is to reduce the progression to cirrhosis, hepatocellular carcinoma, liver decompensation, and death 5.
- Moderate-quality evidence supports the effectiveness of antiviral therapy in reducing the risk of cirrhosis, decompensated liver disease, and hepatocellular carcinoma in patients with immune active chronic HBV infection 8.