Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.
It was a prospective, non-randomized, open-label study that evaluated the efficacy and safety of pegasys treatment in chronic hepatitis B patients with spontaneous HBVDNA decline after acute exacerbation.Patients with spontaneous decline of HBV DNA(a decrease of HBV DNA levels of more than 2 log(10) IU/mL as compared to baseline before antiviral treatment) after acute exacerbation (ALT was 10-30ULN,TBIL was 2-20mg/ml,PTA\>60%)were non-randomly divided into 3 groups: group A, B and C. Before treatment, the patients were counselled on the advantages and disadvantages of taking peginterferon or nucleos(t)ide analogue, and the subsequential treatment were decided by themselves. Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks. Group B and C were control group, cases in group B received an continual entecavir therapy(0.5 mg orally once daily) and those in group C didn't accept any antiviral regiment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
continual entecavir therapy(0.5 mg orally once daily)
Complete viralogic response
Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).
Time frame: week 96
HBsAg loss and seroconversion
HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody. HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only.
Time frame: week 24,48,72 and 96
ALT normalization
ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer).
Time frame: week 24,48,72 and 96
Sick leave in patients in different groups
Time frame: week 48,72 and 96
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