HBV : O-002 ; The efficacy and safety of peginterferon-α-2a in Koreans with hepatitis B: A multicenter study in a real clinical setting = HBV : O-002 ; The efficacy and safety of peginterferon-α-2a in Koreans with hepatitis B: A multicenter study in a real clinical setting

다국어 초록 (Multilingual Abstract)

Background: Genotype C is the principal type of hepatitis B virus in Koreans and is associated with poor prognosis for Peginterferon (PEF-IFN) α-2a therapy. The Korea Health Insurance supports only 24 weeks of therapy in HBeAg positive patients, and there is little report of PEG-IFN α-2a therapy in Korea. Authors investigated the efficacy and compliance to PEG-IFN α-2a therapy in Koreans with chronic hepatitis B (CHB) in a real clinical setting. Methods: CHB patients treated with PEG-IFN α-2a from 2008 to 2011 at four tertiary university hospitals were retrospectively enrolled. Laboratory analyses and adverse events were investigated. Treatment outcomes were evaluated at the end of treatment and at 24 weeks after treatment completion. Results: Eighty-eight patients were enrolled; 67 were HBeAg positive and 50 were men. The mean treatment period was 35.1±8.8 weeks. In 27.3% of the patients, treatment was discontinued due to insufficient antiviral effects (10.2%) and adverse events (9.1%). When patients that completed therapy were analyzed 24 weeks after treatment, 31% of HBeAg positive patients achieved HBV DNA suppression to < 104 c/ml (SVR) and 24.1% of patients achieved HBeAg seroconversion. In HBeAg negative patients, 75% of patients achieved SVR, and 86.7% of patients maintained SVR. By multivariate analysis, a week 24 viral load > 5 log copies/ml was only sig-nificant factor for SVR. During the follow-up period (76.1±46.5 weeks), 29.8% of patients developed a breakthrough HBV DNA level of > 107 c/ml after a reduction to < 104 c/ml and 29.4% of patients reversed HBeAg. No deaths or admissions were attributed to adverse events. Conclusions: These results suggest that PEG-IFN α-2a therapy in Koreans with CHB, showed acceptable virologic response and durability. However, the rate of premature discontinuation was higher in real clinical setting of the present study than in previously reported controlled trials.