Abstract
We investigated the efficacy and safety of PEG-IFN alfa-2a (PEG-IFN) in chronic hepatitis B patients.
In this randomized study, HBeAg-positive patients received: PEG-IFN (90 μg/week or 180 μg/week for 24-weeks or 48-weeks) or IFN (6MIU 3×/week for 24-weeks). The primary endpoint was triple response (HBeAg seroconversion, HBV DNA <5 log copies/mL and ALT normalization) at 24-weeks post-treatment.
Triple response rates were increased according to the dose and treatment duration in PEG-IFN treatment group. Difference of response rates between PEG-IFN 48-week treatment group and IFN group was 11.3% (95% CI: 0.0-22.6) and confirmed non-inferiority in efficacy and tolerability of PEG-IFN compare to the IFN.
In HBeAg-negative patients, PEG-IFN 90 μg/week or 180 μg/week for 48-weeks treatment showed 37.5% or 37.9% of HBV-DNA suppression (<4.3 log copies/mL at 24-weeks post-treatment) respectively.
This study confirmed efficacy and safety of PEG-IFN in chronic hepatitis B.
