To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
180μg/w
Etecavir 0.5mg qd or Tenofovir 300mg qd
180μg/w for 8 consecutive weeks and cessation for 4 weeks
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China
RECRUITINGThe percentage of patients with undetectable HBV DNA
Time frame: week 24
HBsAg clearance rate
Time frame: week 48
HBsAg conversion rate
Time frame: week 48
The percentage of patients with undetectable HBV DNA
Time frame: week 24 and week 48
The HBsAg level
Time frame: week 24 and week 48
The HBV pgRNA level
Time frame: week 24 and week 48
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