Chronic Hepaititis B Clinical Trial
Official title:
An Open-label Trial of 48-week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of Chronic Hepatitis B Patients With HBeAg Seroconversion on Nucleot(s)Ide Analogue Therapy
This is a multi-center, single-arm, open-label study on the virological response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24 weeks after the end of treatment.
Chronic hepatitis B is the commonest cause of liver cirrhosis and hepatocellular carcinoma in
Hong Kong. Treatment with interferon and nucleos(t)ide analogues (NA) can reduce the risk of
HCC. NA is the commonest used medication in Hong Kong. However, most patients require
long-term treatment and premature drug cessation may lead to hepatitis relapse.
Under the current regional guidelines, patients who have positive hepatitis B e antigen
(HBeAg) treated by NA can consider stopping treatment if HBeAg seroconversion has developed
for at least 12 months. However, up to 30-50% of patients may develop virological relapse
and/or HBeAg reversion after cessation of treatment. On the other hand, interferon-based
treatment has a much more durable response. HBeAg seroconversion is maintained in 80% of
patients after successful treatment with peginterferon. Upon long-term follow-up,
peginterferon-treated patients are also more likely to achieve hepatitis B surface antigen
(HBsAg) seroclearance, a condition closest to a cure of chronic hepatitis B.
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