From the Guidelines
Viral hepatitis diagnosis involves serologic and viral markers, liver biopsy, and imaging, while treatment aims to suppress viral replication, alleviate hepatic inflammation, and prevent fibrosis, with antiviral medications like entecavir, tenofovir, or pegylated interferon for hepatitis B, and direct-acting antivirals for hepatitis C. The diagnosis of viral hepatitis is made based on various serologic and viral markers, such as HBsAg, anti-HBs, HBeAg, anti-HBc-IgM/G, and HBV-DNA measurement by PCR assays 1. Liver biopsy is also an effective method for establishing the diagnosis of hepatitis B infection, assessing the severity and prognosis of disease, and should be performed before initiation of antiviral treatment and repeated while on treatment 1. For chronic hepatitis B, treatment goals include decreasing the mortality rate, increasing the survival rate, alleviating hepatic inflammation, and preventing the development of fibrosis, with ultimate goals of normalization of the ALT level, undetectable HBV DNA level, and the clearance or seroconversion of HBsAg and HBeAg 1. Recent studies suggest that universal treatment of HBV with nucleotide reverse transcriptase inhibitors can be cost-effective in preventing cancer and reducing the overall burden of chronic HBV infections and hepatocellular carcinoma 1. Key considerations in the management of viral hepatitis include:
- Transmission routes: hepatitis A and E through contaminated food and water, hepatitis B, C, and D through blood, sexual contact, or from mother to child
- Symptoms: fatigue, jaundice, abdominal pain, nausea, and dark urine, though many infections can be asymptomatic
- Treatment approaches: supportive care for acute viral hepatitis, antiviral medications for chronic forms
- Prevention: vaccination (available for hepatitis A and B), practicing safe sex, avoiding needle sharing, and maintaining good hygiene
- Regular screening: recommended for high-risk individuals to prevent progression to serious complications like cirrhosis or liver cancer.
From the FDA Drug Label
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). Subjects had persistently elevated ALT levels at least 1. 3 times ULN and chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
The diagnosis of viral hepatitis is based on:
- Serum HBsAg-positive for at least 6 months
- Evidence of viral replication (detectable serum HBV DNA)
- Persistently elevated ALT levels at least 1.3 times ULN
- Chronic inflammation on liver biopsy
The treatment for viral hepatitis (specifically chronic hepatitis B virus infection) is:
- Entecavir 0.5 mg once daily, which was shown to be superior to lamivudine in reducing viral load and ALT normalization 2 Key points:
- Entecavir is effective in treating chronic hepatitis B virus infection
- The treatment is given orally, once daily
- The dosage is 0.5 mg per day
From the Research
Diagnosis of Viral Hepatitis
- The diagnosis of viral hepatitis involves assessing the severity of liver damage and prognosis, with the best indicator being the extension of liver fibrosis 3.
- Liver biopsy is traditionally used to define etiology, severity, and prognosis of liver disease, but it is an invasive procedure with associated risks and sampling errors 4, 5.
- Non-invasive methods, including physical and biological approaches, have been proposed as alternatives for diagnosing liver damage 4, 5.
- Serum biomarkers, such as class I and class II biomarkers, can be used to predict liver damage in chronic hepatitis C 4.
- Liver transient elastography (Fibroscan) is a new technology that allows estimation of hepatic fibrosis through measurement of liver stiffness and can reduce the need for liver biopsy in chronic hepatitis 5.
Treatment of Viral Hepatitis
- Treatment guidelines for chronic viral hepatitis are continuously evolving and take into consideration the assessment of liver injury 5.
- Antiviral therapy is used to treat chronic viral hepatitis, and the decision to initiate treatment depends on the severity of liver damage and the presence of other concomitant diseases 3, 6.
- Serological tests and molecular virology, such as genotype and viral load testing, are used to evaluate patients with chronic hepatitis C and plan therapy 7.
- The combination of serological tests and transient elastography can predict liver cirrhosis with high accuracy and may avoid the need for liver biopsy in some patients 3.
Assessment of Liver Disease Severity
- The assessment of liver disease severity is crucial in determining the best course of treatment for patients with chronic viral hepatitis 3.
- Liver biopsy is still considered the gold standard for assessing liver disease severity, but non-invasive methods are becoming increasingly popular due to their safety and accuracy 4, 5, 3.
- Elastography has been shown to have high predictive value for the development of decompensated cirrhosis and portal hypertensive complications 3.