This is a prospective, randomized, open-label clinical trial designed to compare the antiviral efficacy and safety of entecavir 0.5 mg once daily versus entecavir 1.0 mg once daily in adult patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis. A total of 48 participants will be randomized equally to the two treatment groups and followed for 24 weeks. The primary outcome is the reduction in serum HBV DNA at week 24. Secondary outcomes include changes in Child-Pugh and MELD scores, HBeAg seroconversion, development or worsening of hepatic decompensation, occurrence of hepatocellular carcinoma, and safety of treatment.
Age: 18 years or older.
HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence.
Detectable level of HBV DNA irrespective of HBeAg status.
Clinical, biochemical, or radiological evidence of hepatocellular carcinoma.
Coinfection with HCV.
Patient is ongoing antiviral treatment.
Cirrhosis due to other causes.
Parallel
Entecavir
DrugParticipants receive oral Entecavir once daily. The dose is either 0.5 mg or 1.0 mg, according to randomized treatment assignment, 24 weeks.
Change in Serum HBV DNA levels
Comparison of the reduction in serum HBV DNA (IU/mL) from baseline to 24 weeks between receiving Entecavir 0.5 mg/day and 1.0 mg/day.
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